Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer
Phase: NA
Conditions: Cancer, Severe Major Depression, Schizophrenia, Bipolar Disorder, Lung Cancer, Breast Cancer, Head and Neck Cancer, Gastrointestinal Cancer
Sponsor: Massachusetts General Hospital

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DF/HCC SOCIAL-BEHAVIORAL RESEARCH PROTOCOL
Bridge: Proactive Psychiatry Consultation and Case Management for Patients with 
Cancer: 
Version 11.0 - 9.30.2021
SECTION 1: Protocol Schema
Open Pilot
Initial Screen
Enrollment
Baseline Data Collection & Medical Record Review
Interval Data Collection: 4-6 weeks after baseline 
Post-Intervention Data Collection
12 ± 2 weeks after baseline
Post-Intervention Medical Record Review
24 weeks after baseline
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IRB APPROVAL DATE: 10/01/202

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Randomized Controlled Trial
Patient Baseline Data Collection:
Demographics, mental health resource 
utilization, health leads social needs
Patient-Reported Outcomes:
PHQ-9 (Depression)
GAD-7 (Anxiety)
PAM (Activation)
MDASI (Symptom burden)
DMS (Discrimination in Medical Setting)
Clinician-Administered Measures:
Brief Psychiatric Rating Scale (BPRS)
Clinical Global Impression-Severity (CGI-S)
Caregiver Baseline Data 
Collection:
Demographics
Caregiver-Reported Outcomes:
PHQ-9 
GAD-7 
CG-PAM (Activation)
CRA (Caregiver Reaction Assess.)
FAMCARE (Caregiver 
satisfaction with patient’s care)
PMS (Pearlin Mastery Scale)
Patient Baseline Medical 
Record Review:
Cancer history
Charlson Comorbidity Index 
(medical comorbidity)
Smoking behavior
Prior utilization of primary 
care and mental health care
Interval Time Point 
(5-7 weeks after baseline) 
Patient Data Collection:
Patient-Reported Outcomes:
PHQ-9                               PAM
GAD-7                               MDASI
Bridge arm only: 
Clinician Assessment:
Clinical Global Impression-
Improvement (CGI-I)
CGI-S
Interval Time Point
(5-7 weeks after baseline)
Caregiver Data Collection:
Caregiver-Reported Outcomes:
PHQ-9
GAD-7
CG-PAM
CRA
PMS
FAMCARE
Post-Intervention
 (12 weeks  - 2 weeks, + 4 weeks 
after baseline) Patient Data 
Collection:
Patient-Reported Outcomes:
PHQ-9                               FACIT-TS-PS
GAD-7                               PAM
TPS                                    MDASI
Clinician Assessment:
BPRS, CGI-I, CGI-S
*Bridge arm only: Recorded Exit 
Survey (12 weeks – 2 weeks, +4 
week after baseline)
Post-Intervention
(12 weeks  - 2 weeks, + 4 weeks 
after baseline)
Caregiver Data Collection:
Caregiver-Reported Outcomes:
PHQ-9                              CG-PAM
GAD-7                              CRA
PMS                                  FAMCARE
Post-Intervention
(12  weeks +8 weeks after baseline)
Mental Health Clinician Data 
Collection:
Intervention feedback to assess 
acceptability of the intervention
Post-Intervention
(26 weeks ±6 weeks after baseline)
Oncologist Clinician Data 
Collection:
Intervention feedback to assess 
acceptability of the intervention
Post Intervention
Patient Data Collection:
(24 ± 2 weeks after baseline)
PHQ-9                               PAM
GAD-7                               MDASI
                                          
Clinician Assessment:
BPRS, CGI-I, CGI-S
RANDOMIZATION
Proactive Psychiatry Consultation 
(Bridge)
Psychiatric diagnostic interview
Assessment of barriers to care
Co-management from oncology and 
psychiatry
Enhanced Usual Care (EUC) 
Templated email sent upon patient consent 
to treating oncologist informing them of the 
psychiatric diagnosis and available 
psychosocial services. Participants will also be 
informed about available services at consent.
Screening:
Patients with serious mental illness (SMI) and recent diagnosis of lung, breast, gastrointestinal, or head and neck cancer 
within 8 weeks of initial oncology consultation at the Massachusetts General Hospital Cancer Center
Clinician or PI verifies patient is able to consent with the Assessment of Capacity to 
Participate in Clinical Research form and obtains consent
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IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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SECTION 2: Body of Protocol 
*Bridge arm only: Recorded Exit 
Survey
Post-Intervention
(24 weeks after baseline) 
Medical Record Review:
Completion of guideline-
concordant, timely cancer 
treatment
Health care utilization
Communication between oncology 
and mental health team
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IRB APPROVAL DATE: 10/01/202

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TABLE OF CONTENTS
1.0
INTRODUCTION
1.1
Overview
1.2
Background and Rationale
2.0
OBJECTIVES
3.0
PART ONE – OPEN PILOT
3.1     Aim
3.2     Design/Study Type
3.3     Research Subject Selection 
3.4     Research Subject Entry
3.4.1     Registration Procedures 
3.5     Methods
3.5.1     Selection of Instruments
3.5.2     Description of Intervention
3.5.3     Data Collection
3.5.4     Description of Study Process
3.5.5     Adverse Reactions and Their Management 
3.6     Statistical Analysis 
3.6.1     Analysis Plan
4.0
PART TWO – RANDOMIZED-CONTROLLED TRIAL
4.1     Aims
4.2     Study Design 
4.3     Research Subject Selection
4.4     Research Subject Entry 
4.4.1     Registration Procedures 
4.5     Methods
4.5.1     Selection of Instruments
4.5.2     Description of Intervention 
4.5.3     Data Collection
4.5.4     Description of Study Process
4.5.5     Adverse Reactions and Their Management 
4.6     Statistical Analysis 
4.6.1     Primary and Secondary Endpoints
4.6.2     Sample Size and Power Calculation 
4.6.3
 Stratification factors and intervention allocation plan 
4.6.4     Stratification factors and their impact on design 
4.6.5     Analysis Plan
4.6.6     Missing Data Issues 
5.0
PART THREE - DELPHI CONSENSUS METHOD
5.1     Aims
5.2     Study Design
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5.3     Research Study Selection
5.4     Research Study Entry
5.5     Methods
5.5.1     Selection of Instruments
5.5.2     Description of Intervention 
5.5.3     Data Collection
5.5.4     Description of Study Process
5.5.5     Adverse Reactions and their Management 
5.6     Statistical Analysis 
5.6.1
    Analysis Plan 
6.0
PART FOUR – QUALITATIVE INTERVIEWS
6.1
Aims
6.2
Study Design
6.3
Research Study Selection
6.4
Research Study Entry
6.5
Methods
6.5.1
Selection of Instruments
6.5.2
Description of Intervention 
6.5.3
Data Collection
6.5.4
Description of Study Process
6.5.5
Adverse Reactions and their Management 
6.6
Statistical Analysis 
6.6.1
Study Endpoints
6.6.2
Sample Size and Power Calculation
6.6.3
Analysis Plan 
7.0
REFERENCES 
8.0       APPENDICES
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1.0 INTRODUCTION
1.1 Overview
Disparities in cancer treatment markedly increase cancer mortality for patients with 
serious mental illness (SMI). SMI, including schizophrenia, bipolar disorder, and severe major 
depression, affects nearly 13 million U.S. adults who die 15-30 years earlier than the general 
population,1-3 with cancer as the second leading cause of death.3 Patients with SMI are more 
likely to be diagnosed with metastatic disease4,5 and less likely to receive timely, stage-
appropriate treatment.2,4,6,7 Although health disparities research in cancer is a priority,8-10 patients 
with SMI have been understudied and excluded from clinical trials. Without targeted 
interventions, patients with SMI will continue to experience decreased access to cancer care and 
die prematurely from cancer. Despite the challenges of oncology care for patients with SMI, few 
studies have identified remediable drivers of inequities in cancer treatment. High rates of 
smoking, medical comorbidity, and lack of stable primary care affect cancer outcomes but do not 
account for survival disparities.11-13 Patient, clinician, and healthcare systems-level factors may 
impact care delivery: psychiatric symptoms including cognitive disorganization may impair the 
patient’s understanding of a cancer diagnosis; oncologists may lack expertise in communicating 
with patients with mental illness; and mental health care is frequently segregated from cancer 
care. Thus, oncologists often need to make cancer treatment decisions without access to a 
complete medical history or psychiatric consultation. Collectively, these challenges increase the 
risk of cancer care disruptions defined as delays to treatment initiation, deviations from stage-
appropriate treatment, and interruptions in treatment. In our retrospective cohort study of 95 
patients with schizophrenia treated for breast cancer at an NCI-designated comprehensive cancer 
center, one half of patients experienced clinically significant cancer care disruptions; lack of 
psychiatric treatment at cancer diagnosis was the strongest predictor of disruptions in cancer 
care.14 Qualitative interviews with clinicians underscored the need for an interdisciplinary team 
and timely psychiatry consultation.15 Approaches that promote early co-management of cancer 
and SMI are urgently needed to improve outcomes in this underserved population. 
1.2 Background and Rationale
SMI, defined as schizophrenia, bipolar disorder, and severe major depression, 
affects nearly 10 million U.S. adults, who on average die 15-30 years earlier than the 
general population.1-3 Eighty percent of this premature mortality is due to medical illness, and 
cancer is the second leading cause of death.3,16  More than 40% of people with SMI receive no 
mental health treatment.17,18 Furthermore, comorbid mental illness is associated with increased 
utilization of the emergency department, longer hospitalizations, and 2-3 times greater healthcare 
costs.19-21 Patients with schizophrenia and bipolar disorder experience disproportionate rates of 
poverty, homelessness, and social isolation, which represent additional risk factors for decreased 
access to cancer care.11,13,22-24
Delays to cancer diagnosis and inequities in cancer treatment contribute to 
markedly greater cancer mortality for patients with SMI.6,25-27  Compared to individuals 
without mental illness, patients with schizophrenia have 2-4 times greater mortality from breast, 
lung, colorectal, and oral cancers.2,6,11,26 Patients with SMI have decreased access to cancer 
prevention and screening and are more likely to present with metastatic disease.4,5,28 
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Additionally, patients with SMI are less likely to receive guideline-concordant cancer treatment 
including chemotherapy, radiation, and surgery; these inequities in treatment contribute to 
increased cancer mortality.2,4,6,7  Patients with schizophrenia are also less likely to have a 
palliative care consultation at the end of life.29,30 Inequities in cancer treatment and mortality 
persist in countries with universal health care and are not explained by differences in 
socioeconomic status.2,23,31 Patient, clinician, and systems-based factors affect cancer care for 
patients with SMI.22 Psychiatric symptoms including cognitive disorganization and agitation can 
impact a patient’s ability to communicate effectively with the oncologist, leading to delays in 
treatment.2,4,7,32 Physicians with limited experience with SMI may attribute physical complaints 
to a psychiatric illness, leading to missed and delayed diagnoses.33,34 Mental health care is 
segregated from cancer care, and oncologists receive limited training in SMI. Collectively, these 
challenges increase the risk of inequities in cancer treatment that contribute to poor survival. 
Without changes in healthcare delivery, patients with SMI will remain at high risk for premature 
mortality from cancer.
Engaging informal caregivers for cancer patients is one important strategy to 
improve patient care and outcomes, especially for those with SMI.  As cancer care shifts 
from the hospital to the community, informal caregivers have increased responsibility with 
managing complex medications and coordinating complex care. However, clinicians rarely 
include the caregiver in cancer care, and many caregivers feel unprepared, anxious, and 
depressed.35-37  Including caregivers may improve patient outcomes and utilization of care.36 For 
example, family caregiving mastery (perceived control over cancer care), predicted survival of 
patients with glioblastoma.38 Caregivers for patients with SMI and cancer often experience 
additional challenges: patients with SMI may experience cognitive deficits that can impact their 
adherence to medication and how they report their symptoms.39 Moreover, patients may have 
limited insight into the need for cancer treatment and miss appointments.  In such circumstances, 
patients and oncologists find it more difficult to establish a therapeutic alliance.15 Caregivers act 
as advocates to ensure that clinicians ask about and respect patients’ wishes (Preliminary 
Studies). Thus, including caregivers may not only improve caregiver outcomes but also improve 
cancer care for patients with SMI.
Caregivers for patients with SMI are understudied.40 They are likely to be children, 
siblings, or community mental health staff. The NCI has prioritized research including 
caregivers who are adult children/siblings and who are caring for patients underrepresented in 
cancer research.36 Patients with SMI, particularly schizophrenia, may spend the majority of their 
adult lives in residential homes with limited family contact. In our feasibility study conducted in 
2015 (n=30), “Proactive Psychiatry Consultation for Patients with Cancer”, some patients 
identified community mental health staff as their caregivers, who accompanied them to oncology 
appointments. Although staff are paid, they receive minimal training in managing acute medical 
conditions. In our feasibility study, 85% of caregivers recognized the significant challenges of 
caregiving and asked for assistance in advocating for patients, especially those with limited 
insight.41
Although leading oncology organizations prioritize research to ameliorate 
disparities in outcomes for vulnerable populations,10 the disparity in cancer survival 
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experienced by patients with SMI is unrecognized and understudied.  Patients with SMI are 
commonly excluded from clinical trials. For example, mental illness is listed as an exclusion 
criterion on 20% of lung cancer interventional trials on clinicaltrials.gov.42 The integration of 
psychosocial cancer care is recognized as an important component of quality cancer care, and 
distress screening is a national mandate and accreditation standard.43,44 New models of integrated 
cancer and mental health care are needed to meet mandates for accreditation and promote timely, 
flexible, responsive care.
Collaborative care is a patient-centered, evidence-based approach to integrate 
behavioral health informed by Wagner’s Chronic Care Model.45 The proposed intervention 
is informed by the Chronic Care and Collaborative Care models, which aim to bridge the 
community and healthcare system as well as engage the patient and clinician, thereby improving 
health outcomes. Collaborative care utilizes an interdisciplinary team (i.e., a nurse or case 
manager embedded within the medical team) to identify patient goals and engage patients in their 
care. Case managers use evidenced-based treatments and facilitate rapid access to psychiatry. 
Patient outcomes are tracked using validated measures over time. Collaborative care was first 
tested in primary care, with multiple randomized trials demonstrating improved depression, 
functioning, patient satisfaction, and cost-effectiveness compared to enhanced usual care.46-49 
More recently, collaborative care has been adapted to treat depression in patients with cancer, 
and a systematic review showed that collaborative care interventions appear superior to other 
psychosocial interventions for these patients.50-55 Furthermore, among patients with bipolar 
disorder, collaborative care increases access to primary care and improves physical health 
outcomes.56-58 However, no collaborative care studies to date have targeted patients with 
preexisting SMI and cancer, a population that requires a rapid response and specialty 
expertise.  
Conceptual Model
We developed the Proactive Psychiatry Consultation intervention (Bridge) for patients 
with SMI (Figure 1).59 Bridge, is a 12-week patient and caregiver-centered intervention. At the 
time of cancer diagnosis, the oncologist and psychiatrist co-manage the patient and adapt cancer 
treatment. Bridge is informed by the Chronic Care Model: The case manager (social worker) 
engages the patient and caregiver, coordinates care, and facilitates communication among 
clinicians. In addition, the case manager promotes self-management and patient and caregiver 
engagement in care. Bridge decreases the severity of psychiatric symptoms.
Figure 1: The Bridge Care Model for Patients with SMI at Cancer Diagnosis59
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Innovation
The proposed study is highly innovative in terms of the target population, the 
intervention, and the approach. First, individuals with SMI are understudied and frequently 
excluded from clinical trials. Second, collaborative care has not been adapted to patients with 
both SMI and an acute medical condition like cancer, which requires a rapid response, specialty 
expertise, and co-management across systems. Third, we are engaging underrepresented 
caregivers: adult children, siblings, parents and community mental health staff. Fourth, we have 
developed and piloted the first intervention in our feasibility study targeting patients with SMI at 
the time of cancer diagnosis and now propose the first RCT of an intervention for this vulnerable 
population. Fifth, we are utilizing a mixed methods approach including qualitative interviews 
with multiple stakeholders to determine strategies to implement Bridge effectively in the 
community.
Support from Additional Preliminary Studies
Patients with SMI experience frequent and significant disruptions in their cancer care. 
We developed a framework to identify disruptions in cancer care and examined modifiable 
predictors of disruptions for patients with SMI. In a retrospective cohort study of 95 patients with 
preexisting schizophrenia treated for breast cancer at the Dana-Farber/Harvard Cancer Center, 
50% of patients experienced clinically relevant care disruptions defined as delays to diagnosis 
and treatment initiation, deviations from stage-appropriate treatment recommended by the 
clinician, and interruptions in planned cancer treatment. After adjusting for age, insurance, and 
having a primary care physician, lack of psychiatric treatment at cancer diagnosis was the 
strongest predictor of delayed treatment.14 Compared to 1.5% of patients without mental illness 
nationally, 23% of patients with schizophrenia had a delay of more than 90 days from diagnosis 
to surgery.25 More than one quarter of these patients had delays to chemotherapy and 
radiation.60,61 Oncologists documented a treating psychiatrist in only 31% of patients and 
consulted psychiatry for less than 10% of their patients. Patients without a documented 
psychiatrist were four times more likely to have cancer care disruptions.14 Increasing access to 
psychiatric treatment at cancer diagnosis may decrease disruptions in cancer care.
We interviewed 33 oncology and mental health clinicians to identify strategies to address 
barriers to cancer care for people with SMI.  Clinicians emphasized the need for 1) increased 
access to psychiatry consultation at cancer diagnosis, 2) improved communication among 
oncology clinicians and community mental health clinicians, and 3) an interdisciplinary patient-
centered approach to build trust and address complex patient needs including the social 
determinants of health.15 These data support the need for a multi-level, health systems 
intervention to identify SMI and promote joint management of cancer and SMI by psychiatry and 
oncology. To ameliorate inequities in cancer outcomes for individuals with SMI, it appears 
critical to address patient, clinician, and health-systems factors including the stigma of mental 
illness.
From 2015-2016, we conducted a feasibility study (n=30) to assess the feasibility and 
acceptability of Bridge including identifying and enrolling patients and completing the study. 
Participants had SMI (schizophrenia, bipolar disorder, and severe MDD) and a recent diagnosis 
of lung, breast, gastrointestinal, or head/neck cancer (i.e., cancers with mortality disparity in 
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patients with SMI).6,7,11,26,27 Due to the demand for such an intervention, we completed 
recruitment ahead of schedule in 5 months. Eighty-eight percent of patients or their guardians 
consented to the trial (goal 50%), and 88% completed all assessments (goal 75%). Psychiatric 
symptoms improved as measured by the Brief Psychiatric Rating Scale62 (baseline mean total 
BPRS 45.6, 12 week BPRS 41.0, p=0.018). During the trial, we became aware that caregivers 
frequently played a central role in the patients’ cancer care. We asked patients to identify a 
caregiver, defined as a person who accompanied them to cancer center appointments or 
participated in medical decision-making.  Patients were not required to have a caregiver to 
participate in the feasibility study. In exit interviews, 85% of caregivers (n=20) reported that the 
intervention addressed the challenges of caregiving for patients with SMI and cancer. 
Furthermore, 85% of oncology clinicians (n=26), reported that the intervention positively 
impacted cancer care. Five patients who had delays in their cancer care ranging from 4 weeks to 
15 months prior to the intervention, received recommended cancer treatment during the study. 
We now propose to conduct an open pilot study and single-site RCT to refine the intervention 
and assess the preliminary efficacy of Bridge in decreasing disruptions in cancer care.
Next Steps
Our qualitative research, retrospective cohort study, and feasibility study of Bridge have 
highlighted the importance of developing and implementing a model of care that helps connect 
cancer care and mental health care. This single-site RCT will prepare our research team for a 
pragmatic, multi-site, hybrid effectiveness-implementation trial of integrated psychiatry and 
cancer care, utilizing robust research and training plans to implement and disseminate the model 
on a larger scale. We will use the information gathered in this trial to further refine our model of 
proactive psychiatric consultation.
2.0 OBJECTIVES
Our overall goal in this program of research is to eliminate disparities in cancer mortality 
of patients with SMI. With this proposed single-site RCT, we will assess the preliminary efficacy 
of the Bridge model and create an implementation strategy that can be tested in a larger scale, 
R01-funded trial to investigate the effectiveness of Bridge in improving cancer care for patients 
with SMI and their caregivers. 
Specific Aims
Aim 1: To refine the patient and caregiver intervention, pilot patient and caregiver 
measures, and finalize the intervention manual in the open pilot in preparation for 
conducting the RCT. 
Aim 2: To assess the impact of the Proactive Psychiatry Consultation intervention (Bridge) 
on cancer care 
Hypothesis 1: Compared to enhanced usual care (n=60), patients randomized to Bridge (n=60) 
will be less likely to experience cancer care disruptions (delays to treatment initiation, deviations 
from stage-appropriate treatment, and interruptions), have shorter time to cancer treatment 
initiation, and have improved healthcare utilization (fewer missed oncology appointments and 
decreased unplanned acute care).
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Aim 3: To assess the impact of Bridge on patient and caregiver-reported outcomes 
Hypothesis 2a: Patients randomized to Bridge will have greater improvement in psychiatric 
symptoms, engagement in cancer care, and satisfaction with cancer care compared to patients 
in enhanced usual care.
Hypothesis 2b: Caregivers of patients randomized to Bridge will have decreased caregiver 
burden, and greater improvement in caregiving mastery, engagement in cancer care, and 
satisfaction with care, compared to caregivers in enhanced usual care.
Aim 4: To develop metrics for disruptions in cancer care based on cancer type, stage and 
other clinical characteristics.
3.0 PART 1 - OPEN PILOT 
3.1 Aim: To refine the patient and caregiver intervention, pilot patient and 
caregiver measures, and finalize the intervention manual in the open pilot in preparation 
for conducting the RCT. 
3.2 Design/Study Type
Open Pilot: Refining Bridge and Study Procedures (Months 0-2): We will conduct an 
open pilot with 8 patients with SMI and cancer and their caregivers (n=7). We will test the 
procedures to identify, screen, and consent patients and caregivers as well as pilot validated self-
report measures and refine the intervention. The open pilot, a critical component to develop the 
intervention, will enable the team to assess the feasibility and acceptability of the revised 
caregiver procedures and measures. Additionally, we will pilot the qualitative exit surveys for 
oncology and mental health clinicians, developed in partnership with clinicians, patients and 
caregivers and informed by the constructs from the Conceptual Framework of Intervention 
Research (CFIR).63,64 Based on the open pilot, we will refine the intervention manual and final 
measure selection. The study team will submit an amendment to the IRB noting any 
protocol changes before beginning the RCT.
3.2 Research Subject Selection 
Patient Participants:
The following inclusion criteria will be used:
1. Age > 18 years old
2. Verbal fluency in English
3. SMI (Schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder 
with prior psychiatric hospitalization) confirmed by diagnostic evaluation of study 
psychiatrist
4. Invasive breast, lung, gastrointestinal, or head and neck cancer  (suspected or confirmed 
according to documentation by the oncologist or pathology)
5. Oncology consultation at MGH Cancer Center within the past 8 weeks 
The following exclusion criteria will be used: 
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1. Have cognitive impairment severe enough to interfere with completing brief study 
assessments or providing informed consent (and does not have a guardian who can 
provide consent)
2. Refuse participation 
Rationale: Individuals with SMI including schizophrenia, bipolar disorder, and severe 
major depression die 15-30 years earlier than the general population. Patients with SMI experience 
disparities in cancer treatment that contribute to increased risk of cancer mortality. Importantly, 
psychiatric treatment may influence the delivery of guideline concordant care for this underserved 
population. Our previous research study of patients with schizophrenia and breast cancer treated 
at the Dana-Farber/Harvard Cancer Center (DF/HCC) identified that the lack of psychiatric 
treatment at the time of cancer diagnosis was a key predictor of cancer care disruptions. 
Stakeholders called for a team-based approach and early psychiatry involvement. Therefore, we 
hypothesized that the time of cancer diagnosis was a critical target of our intervention because at 
this critical time we can facilitate the collaboration between oncology and psychiatry and influence 
cancer treatment decision-making. We will include patients with breast, lung, gastrointestinal, and 
head and neck cancers because of documented disparities in mortality from these specific cancer 
sites in patients with SMI.6,7,11,26,65 We will include patients with uncontrolled psychiatric 
symptoms and co-morbid substance use to ensure that we are not excluding patients who can 
benefit from the intervention and that we are capturing a sample that is clinically relevant to the 
practicing oncologist because of their significant barriers to engaging in their cancer care. We will 
exclude patients receiving cancer care at a separate institution since our intervention consists of 
intensive collaboration between multiple disciplines within MGH. Coordinating this care for 
patients receiving care at a different hospital is not feasible in this single-site study. However, 
patients with outside mental health clinicians will be integrated into the study. Like our feasibility 
study, we will establish communication with outside mental health clinicians at the time of study 
enrollment. The goal is not to assume responsibility for mental health care, but instead to act as a 
bridge to communication and to provide focused consultation from a psychiatric oncologist 
regarding barriers to cancer care. We will communicate with all mental health clinicians at the 
beginning and conclusion of the study to ensure that direct communication is established between 
the oncology team and the (outside) community mental health team. This model of care is utilized 
frequently within our consultation psychiatry group. We will exclude patients with low English 
literacy to ensure participants can complete study assessments. This will allow us to validate the 
study questionnaires within this patient population. Future trials may tailor this trial for non-
English speaking patients. 
Given the prevalence of guardians for the most vulnerable patients and the low risk of this 
study, we will allow guardians to provide consent for patients to participate. Participants will also 
be asked for their assent to participate in the study. As we found during our feasibility study, 
cognitive deficits in processing speed and understanding of complex, abstract language is 
challenging for many patients with schizophrenia and some patients with bipolar disorder. 
Additionally, the symptom of paranoia (strong fear about the intentions of others) and institutional 
distrust, pose barriers to the act of signing legal documents.  We found that utilizing a verbal 
consent process administered by a clinician with expertise with serious mental illness led to the 
most opportunity to answer questions, use concrete language, and repeat information in digestible 
quantities. The clinicians will complete the Assessment of Participation to Consent form, which 
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offers an additional process to protect patients and ensure full understanding of the risk and 
benefits. If needed or preferred by patients, patients can fill out the questionnaires with the 
guidance of a caregiver or with study staff.   
Caregiver Participants: 
The following inclusion criteria will be used:
1. Age > 18 years old
2. Verbal fluency in English
3. Family or community-based caregiver who accompanies the patient to medical 
appointments or participates in decision-making about cancer care
4. Patient participant identifies or confirms caregiver’s involvement, provides permission to 
contact caregiver
Rationale: We are interested in caregivers who are actively and consistently involved in 
the patients SMI and/or cancer care. From our previous work, we know that these caregivers may 
be family members (frequently children, siblings, or parents) or community mental health staff. 
Although there are differences in the type of relationship, both family caregivers and community 
caregivers provide considerable informational, instrumental, and emotional support for patients 
with SMI and cancer, and therefore are key partners in the intervention. Moreover, exit interview 
data from our previous research and clinical experience underscore the unmet needs of caregivers 
and their role in facilitating the patient’s cancer treatment. Caregivers will need basic English 
literacy to complete study questionnaires and will be valuable to pilot measures of caregiving 
experience, mastery, anxiety and depression symptoms, and engagement in the patient’s cancer 
care.
Clinician Participants:
The following inclusion criteria will be used:
1. Are an oncologist or oncology nurse practitioner primarily providing direct oncology care 
at the MGH Cancer Center; or are a licensed community mental health clinician (e.g. 
psychiatrist, psychiatric nurse practitioner, psychologist, social worker, licensed mental 
health clinician, or mental health nurse) with greater than one year treating patients 
2. Had a patient who participated in the study 
Rationale: We will include clinicians with direct experience with our open pilot study so 
that they can provide informative, personal insights and suggest ways in which we can improve 
for the randomized-controlled trial during the qualitative exit interviews.
3.4 Research Subject Entry 
Patient Recruitment: 
In partnership with the Research Patient Data Registry (RPDR) team at MGH, we are 
developing a population-based system to establish a cohort of MGH patients with SMI and a recent 
diagnosis of breast, lung, gastrointestinal, or head and neck cancer. Our eligibility criteria for 
patients, caregivers, and oncologists are listed above. We will update this registry every 24 hours 
to rapidly detect patients with SMI and track cancer treatment. Additionally, study staff will review 
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new consultation lists regularly distributed by oncology clinics and continue to receive referrals 
from oncologists, social workers, and community mental health providers. Based on enrolling 30 
patients in less than 5 months in the feasibility study, we estimate that we will randomize at least 
90 patients in 16 months (1-2 patients per week) if the consent rate is lower than estimated from 
the feasibility study.
Study staff involved in recruitment include myself (principal investigator), a trained, 
Collaborative Institutional Training Initiative (CITI)-certified research assistant, and CITI-trained 
clinicians with expertise working with patients with mental illness and cancer including: a social 
worker (case manager), and a psychiatrist (study clinician). Our proposed study procedures are 
based on our prior research with individuals with SMI through the MGH Schizophrenia Program 
(particularly regarding protection of vulnerable populations) and our research group’s experience 
with recruitment of patients for our feasibility study. We previously obtained permission from the 
clinical directors of the four disease clinics in which we will recruit, and these procedures worked 
well in the feasibility study. We will screen patients for history of SMI in the following ways: 
1) The research assistant will review the breast, gastrointestinal, thoracic, and head and neck 
oncology schedules of new patient evaluations which are distributed weekly. To facilitate 
identification of potential participants and confirm eligibility, study staff may review 
minimal data in the patients’ electronic medical record including medications 
(antipsychotics and mood stabilizers) and past medical history. 
2) We will collaborate with disease-center specific social workers and oncology clinicians in 
breast, gastrointestinal, thoracic, and head and neck oncology clinics who are integral 
parts of the cancer team and frequently involved with individuals with SMI when starting 
cancer treatment. 
3) We will provide education to access nurses who are often the first point of contact for new 
patient referrals to the cancer clinics. We will also remain in communication with 
community-based cancer navigators who work with patients who have challenges 
accessing cancer care. 
4) We will collaborate with the inpatient oncology consultation service and psychiatry 
consultation service to identify patients with SMI and cancer newly diagnosed during a 
hospitalization.
MGH study staff will approach patients after permission to do so has been obtained from 
the patients’ clinicians (see Open Pilot Appendix F). If potential subjects do not have an upcoming 
oncology appointment within a week, study staff will send a recruitment letter and study fact sheet 
(Open Pilot Appendices B, C) to the patient’s home with the permission of their physician. If the 
patient does not respond within a week, study staff may call the patient to go through the letter 
with the patient and ask if they are interested in meeting with the study PI. Any study activities 
will be coordinated with scheduled oncology appointments when possible to minimize patient 
burden.
All clinicians who are recruited will be caring for patients who are participating in the study 
and will have already received communication from the study team during the trial. We will reach 
out to clinicians via email or phone to participate in exit interview (see Open Pilot Appendices 
R-T) Mental health clinicians may be from both MGH or the community (outside MGH). 
Enrollment: After referral from the oncology team, the PI or a study clinician will meet 
privately with each patient to confirm eligibility, explain participation in the open pilot, and 
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review risks and benefits. If a study clinician (physician, psychologist, or social worker) 
determines that the patient has the capacity to provide informed consent, they will sign the 
Assessment of Capacity to Participate in Clinical Research form (validated in clinical research 
with patients with schizophrenia)66,67 and used in our feasibility study, which verifies that the 
patient is interested in participating, understands that participation is voluntary, and understands 
that declining participation will not affect his or her medical treatment. Patients who are judged 
to have capacity will then meet with the PI or study clinician to review the study protocol and 
consent form and obtain informed consent. If the subject would like to have family or residential 
staff present, they will be invited and encouraged to participate. Subjects will be informed that 
they are free not to participate in the study and may withdraw consent to participate at any time. 
They will be told which alternative treatments are available if they refuse to take part and that 
such refusal will not prejudice future treatment and informed of situations in which a breach of 
confidentiality is possible (such as a psychiatric emergency). Subjects will be given the 
opportunity to ask questions. Once enrolled, patients will be asked to identify a caregiver. Once 
screened as eligible for participation, the PI or study clinician will then perform the same consent 
procedures with the caregiver. A patient’s participation does not depend on the caregiver’s 
participation. The study protocol will be submitted in full to the DF/HCC IRB for review and 
approval. We will make efforts to enroll participants of a minority background within each 
clinic.
Patient Retention: Successful retention procedures based on experience with the feasibility 
study and prior projects will be implemented. The research assistant will track retention and the 
PI and case manager will proactively monitor the process of cancer treatment and maintain 
communication with the participant’s oncology team. Study visits will be scheduled concurrently 
with medical visits. The case manager will be in communication with each patient participant at 
least every 2 weeks, and each caregiver participant at least every 4 weeks. The amount of contact 
will be individually tailored to each participant’s needs, following the principles of patient-
centered care. We will collect extensive locator information on patients in the event that 
participants move, change their care from MGH Cancer Center to a different cancer center, or 
otherwise lose contact. Retention will also be facilitated because patients consult regularly with 
their oncology care team during the course of active treatment and this open pilot will be focused 
on that time period.
3.4.1 Registration Procedures  
General Guidelines for DF/HCC and DF/PCC Institutions
Institutions will register eligible participants in the Clinical Trials Management System (CTMS) 
OnCore as required by DF/HCC SOP REGIST-101. When required by REGIST-101, registration 
must occur prior to the initiation of protocol-specific procedures or assessments.
3.5 METHODS
3.5.1 Selection of Instruments 
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Clinician-Administered Measures
1. The Brief Psychiatric Rating Scale (BPRS), 24 items, is used extensively in bipolar 
disorder, schizophrenia, and major depression, strong psychometric properties and 
sensitivity to change62 
2. The Clinical Global Impression-Severity (CGI-S) scale (range 1-7) is a brief 
measure that has good face validity with clinicians in terms of assessing current illness 
severity (based on observed and reported symptoms, function and behavior. It is 
correlated with the BPRS, and could be integrated into the process of cancer care with 
minimal burden on patients or oncology teams68 89
3. The Clinical Global Impression-Improvement (CGI-I) scale (range 1-7) rates 
clinically meaningful change in the patient condition from the baseline of the study. 
The CGI-I score generally tracks with the CGI-S score such that improvement in one 
follows the other.89
4. The psychiatric diagnostic interview and assessment of barriers to care will be 
conducted by the PI, a psychiatrist with expertise in cancer care and SMI and/or care 
manager, a licensed SW with extensive oncology experience (intervention only). The 
interview will be informed by relevant modules of the MINI CR69 (including 
psychosis and major mental illness) and criteria established by the Diagnostic and 
Statistical Manual, Version 5. Additionally, the psychiatrist will assess the severity of 
current psychiatric symptoms, past psychiatric history, substance use, confirm 
medications, and confirm the presence of mental health clinicians and family supports. 
The interview will assess barriers and facilitators to cancer care, patients’ 
understanding of their cancer diagnosis, and identify the patient’s current priorities for 
treatment. The assessment will take approximately 30 minutes and the psychiatrist and 
case manager will share information to minimize patient burden. 
Patient and Caregiver Self-Report Assessments
1. Demographics will include items about the patient’s race, ethnicity, relationship 
status, work status, education, income, and housing status. The resource utilization 
questions will include previous contact with mental health treaters and primary care.
2. The Patient Health Questionnaire-9 (PHQ-9) is a brief, 9-item depression screen 
that has been used extensively in medically-ill populations, has been validated in 
cancer patients, and used in prior supportive care studies70-73
3. The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a 7-item self-report 
scale to screen for generalized anxiety disorder and assess its severity74
4. The Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-
General (FACIT-TS-PS Version 4) is a 16-item instrument measuring 
communication with the physician and trust in the care team75 
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5. Discrimination in Medical Settings Scale (DMS) is a 7-item measure of perceived 
discrimination in healthcare settings, adapted from the Everyday Discrimination 
scale.90 The measure has excellent internal consistency, reliability, and validity and 
has been used in medically-ill and underserved populations. We will pilot the DMS 
scale in patients with SMI.
Patient Self-Report Assessments
1. Patient Activation Measure (PAM) is a 13-item measure of patient activation that 
captures ability to participate in cancer care, validated in patients with SMI and 
cancer76 
2. The M.D. Anderson Symptom Inventory (MDASI) is a 19-item instrument that 
assesses the most common physical and psychological symptoms related to cancer77 
3. Health Leads Social Need Screening Toolkit is a validated brief screening tool that 
assesses the social determinants of health which focuses on remediable measures of 
material hardship linked with poor health outcomes78
4. Psych Resource Utilization Questionnaire is a description of mental health services 
utilized. 
5. Trust in Physician Scale (TPS) is an 11-item measure to assess a patient’s 
interpersonal trust in his or her physician.91 We will pilot the TPS in patients with 
SMI.
Caregiver Self-Report Assessments
1. Caregiver Patient Activation Measure (CG-PAM) is a 13-item measure of caregiver 
activation and participation in the patient’s cancer care79
2. The Caregiver Reaction Assessment is a 23-item measure of caregiver burden with 5 
subscales, 1 positive, validated in caregivers of cancer patients80
3. The Pearlin Mastery Scale is a 7-item measure of mastery, perception of being able 
to impact and have control over care, validated in caregivers of cancer patients81 
Medical Record Review
We will review the EHR to identify time to cancer treatment (interval from initial 
oncology consultation to cancer treatment initiation), missed oncology appointments, ED visits 
and medical and psychiatric hospitalizations. Additionally, we will assess the systems-level 
factor of integration of care by tracking the number of joint oncology and psychiatry visits. Data 
on healthcare utilization will be obtained by review of the MGH EHR and the Massachusetts All 
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Payers Claims Database which includes private and public claims for healthcare (inpatient, 
outpatient, ED, pharmacy) received Massachusetts residents.82 

Patient demographics (e.g., age, sex)

Cancer diagnosis and treatment factors

Mental illness diagnosis

Smoking behavior

Primary care visits

Mental health visits

Missed oncology appointments

Emergency room visits

Medical and psychiatric hospitalizations

Documented communication between oncology and mental health team
Intervention Feedback 
We will gather patient, caregiver, oncology and mental health clinician perspectives on 
the feasibility, acceptability, and usefulness of the open pilot by conducting brief semi-structured 
surveys (5-10 minutes) at 12 ± 2 weeks post-intervention on the feasibility and usefulness of the 
intervention. The surveys will be completed via email, in-person, or by phone according to the 
participant’s preference. Qualitative responses will be recorded and transcribed verbatim. After 
obtaining consent, we will record the initial proactive psychiatry consultation to elucidate 
intervention components and assess intervention fidelity. Study staff will be trained in qualitative 
methods by the PI and co-investigator and Director of the MGH Qualitative Research Unit, Elyse 
Park, PhD.  
3.5.2 Description of Intervention
Intervention Model of Proactive Psychiatry Consultation and Case Management 
(Bridge): In this open pilot, the goal will be for patients to have psychiatry involved within 8 
weeks of their initial oncology consultation. The PI has published a 2014 review in Cancer that 
identified key components of an initial oncology consultation for patients with SMI.22 The 
intervention is designed to be flexible and tailored to the individual patient’s needs. Patients who 
do not wish to see a psychiatrist in the office may be seen in infusion, the hospital, or together 
with the oncology clinician. The psychiatrist will optimize the management of mental illness and 
collaborate with the oncologist to guide the delivery of optimal cancer treatment. The case 
manager will function as a point of contact for the patient to promote self-management, increase 
engagement in cancer care, identify and engage the caregiver when present, and bridge 
communication between cancer and mental health clinicians. Grounded in the principles of 
collaborative care and drawing from our retrospective cohort study at the MGH Cancer Center 
and qualitative interviews from oncologists, mental health clinicians, and patients with a history 
of SMI and cancer, and our previous feasibility study, Bridge incorporates the following key 
components.
(1) Patient-centered care individualized for the patient’s needs and goals for treatment
(2) Assessment by psychiatrist of the severity of the patient’s symptoms and psychiatric 
history focused on potential impact on cancer treatment and identification of barriers 
to treatment
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(3) Engagement of a case manager who builds a relationship with the patient to promote 
self-management and adherence with cancer care, coordinates communication among 
clinicians
(4) Collaboration with SW and oncology team to address barriers and facilitators to 
cancer treatment 
(5) Ongoing availability of the psychiatrist for consultation in the patient’s care including 
regular communication with the oncology clinicians involved in the patient’s care, 
tracking of psychiatric symptoms and quality of life, and monitoring of the process of 
cancer treatment 
The below table details the components of the Bridge intervention:
Assessment and Follow-Up
Communication
Case Management/Social Work
1.Initial assessment by 
psychiatrist of psychiatric 
symptoms and barriers to 
cancer care, note in EHR
2. Recommendations emailed to 
oncologist, SW, and 
community mental health 
team
3. Study staff review patient 
location daily for encounters
1.Psychiatrist proactively reviews EHR 
weekly
2.Psychiatrists emails oncology 
clinicians at least every 2 weeks 
during intervention
3. Co-management: At least one joint 
visit between oncology and psychiatry 
or telephone discussion about cancer 
care management 
4. Psychiatrist and CM available by page
1. Assess barriers to cancer care
2. Identifies family/community 
caregiver and establishes direct 
communication
3. Communicates with patient 
once every two weeks, has 
direct phone line w/text
4. Bridges clinician-to-clinician 
communication 
3.5.3 Data Collection
We will collect and enter all patient data using written forms which the RA will enter into 
a Research Electronic Data Capture (REDCap) database. The REDCap Survey is a tool for 
building and managing online surveys. Our research team has extensive experience using 
REDCap and will create and design the surveys in a web browser, with institutional information 
technology support. The REDCap Survey system offers secure, HIPAA compliant, web-based 
applications that provide an initiative interface for participants to enter data, with real-time 
validation rules (automated data type and range checks) at the time of entry. Medical record 
review data will also be collected and entered electronically using REDCap.
The following table depicts the measures and time points for the proposed data collection.
Post-Intervention
Data
Baseline
6 Weeks
12 Weeks ± 2 weeks
24 weeks
Clinician-Administered Measures
Psychiatric symptoms (BPRS)
X
X
Psychiatric illness severity (CGI-S)
X
X
X
Psychiatric illness improvement (CGI-I)
X
X
Patient and Caregiver Self-Report
Depression and anxiety symptoms (PHQ-9, GAD-7)
X
X
X
Satisfaction with cancer care (FACIT-TS-PS)
X
Discrimination in healthcare (DMS)
X
X
X
Patient Self-Report
Patient Activation Measure (PAM)
X
X
X
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Symptom burden (MDASI)
X
X
X
Trust in Physician Scale (TPS)
X
X
Resource utilization and social needs screening
X
Caregiver Self-Report
Caregiver Patient Activation Measure (C-PAM)
X
X
X
Caregiver burden (Caregiver Reaction Assessment)
X
X
X
Caregiver mastery (Pearlin Mastery Scale)
X
X
X
Medical Record Review
X
3.5.4 Description of Study Process
Study Instrument Administration 
Patients will complete the baseline survey in the outpatient clinic, in the infusion suite, or 
during hospitalization. If patients and/or caregivers refuse or are unable to complete the 
questionnaires on the computer, they will be permitted to use paper versions. The RA will 
contact patients (in person or via telephone) no more than 4 times over the course of two weeks 
to remind them to complete and return the surveys. If study participants fail to complete to 
surveys within two weeks of the expected time point, we will report the data as missing and 
document the reason for incompletion. If participants are not able to return to the clinic and 
prefer to complete study assessments at their houses, a study clinician or trained research 
assistant will provide that option to subjects. The 12-week assessment of the BPRS will be 
completed by an independent study assessor who is blinded to intervention arm. The 12-week 
clinician exit surveys can be completed via email, phone, or in person, whichever is least 
burdensome for the clinicians. Responses will be recorded and transcribed verbatim. 
Intervention Administration 
The intervention, proactive psychiatry consultation and case management, will be 
administered in a way that supports the privacy of the patient. Patients will be offered to be seen 
in a private room. They will be informed that elements of the psychiatric consultation will 
become parts of their medical record and that they psychiatrist will be in communication with the 
oncology team regarding elements of the consultation that may impact their cancer care.
Special Concerns 
We anticipate that psychiatry consultation with completion of questionnaires constitute a 
low-risk study. The PI, a psychiatrist with expertise in patients with SMI will be available as a 
resource if there are any concerns about impact of the intervention on the patients or caregivers 
who are involved in the study.
Compensation
We will provide $25 to participating patients and caregivers after completion of initial 
questionnaire and evaluation, and an additional $25 after completion of the exit interview, for a 
total of $50. No compensation will be provided for oncology clinicians or mental health 
clinicians who participate in the study.
3.5.5 Adverse Reactions and Their Management
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Reporting Adverse or Unanticipated Events
Anticipated Reactions
As this is a behavioral study, there are no ingested medications, and no biomedical 
procedures. It is unlikely that participants will be at any risk for physical harm because of study 
participation. Should participants exhibit or express distress or anger, they will be reassured by 
the Research Assistant that they need not answer any questions which they find upsetting. They 
will also be reminded that study participation is voluntary. If participants remain distressed, both 
the Principal Investigator and the oncology team will be notified. Should several participants 
express distress over an individual item, the research team will review the questionnaire and 
contact the IRB to consider removing it from the study.
If distressed patients need outpatient services for increased psychiatric symptoms, the 
social worker from the disease center will be contacted. If they require further outpatient 
psychiatric services or are at risk for self-harm requiring hospitalization, the PI (a licensed 
psychiatrist), study clinician (a licensed social worker) or designee (a doctoral-level psychologist 
or psychiatrist) will make the necessary referral for treatment, or be in communication with the 
subject’s oncology and community mental health team.
If participants report severe distress or suicidal ideation during the interview or while 
completing any of the questionnaires, the research team will inform the participants that there is 
an obligation to report this to the patients’ primary oncology team and social worker. The PI will 
be available by page if there are any urgent concerns regarding patient safety. Surveys will also 
be scored in real time. If a study staff member identifies patient distress via survey responses, the 
study staff member will page the PI Kelly Irwin, MD (a licensed psychiatrist), study clinician 
Amy Corveleyn (a licensed social worker), co-investigator April Hirschberg, MD (a licensed 
psychiatrist) or other designee who will be available to evaluate and meet with the patient to 
determine if the patient requires further intervention for his or her symptoms. The PI will also 
assess for any suicidal ideation and ensure that the patient is not at any risk for self-harm. The 
patient will remain on study or be referred to a higher or more intensive level of care as 
appropriate.
Reaction Management 
            If distressed patients need outpatient services for anxiety or depression, or if they are at 
risk for self-harm requiring hospitalization, the PI or designee (a doctoral-level licensed 
psychiatrist or psychologist) will make the necessary referrals for treatment. For instance, 
patients who are distressed but not a danger to self or others may be referred to a counselor at 
MGH oncology social work. If suicidality or risk of harm to others is otherwise discovered at 
any study visit, the participant will be referred to appropriate services. In case the hospitalization 
is required for a participant at MGH Cancer Center, the PI will contact and escort the patient to 
the MGH Acute Psychiatry Service (617-726-2995), with the aid of the MGH Police & Security 
if necessary (617-726-2121). 
3.6 Statistical Analysis 
3.6.1 Analysis plan.
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Aim 1: To refine the patient and caregiver intervention, pilot patient and caregiver 
measures, and finalize the intervention manual in the open pilot in preparation for 
conducting the RCT. 
During an open pilot of 8 patients and 7 caregivers, exit interview data and individual 
interview data with oncology and mental health clinicians will be used to refine and strengthen 
the intervention protocol and assess the acceptability of the measures and study procedures. The 
results of the open pilot will inform the RCT. The study team will submit an amendment to the 
IRB reflecting any changes to the intervention protocol before moving forward with the RCT.
4.0 PART 2 – RANDOMIZED-CONTROLLED TRIAL
4.1 Aims 
Aim 2: To assess the impact of the Proactive Psychiatry Consultation intervention (Bridge) 
on cancer care 
Hypothesis 2: Compared to enhanced usual care (n=60), patients randomized to Bridge (n=60) 
will be less likely to experience cancer care disruptions (delays to treatment initiation, deviations 
from stage-appropriate treatment, and interruptions), have shorter time to cancer treatment 
initiation, and have improved healthcare utilization (fewer missed oncology appointments and 
decreased unplanned acute care).
Aim 3: To assess the impact of Bridge on patient and caregiver-reported outcomes 
Hypothesis 3a: Patients randomized to Bridge will have greater improvement in psychiatric 
symptoms, engagement in cancer care, and satisfaction with cancer care compared to patients 
in enhanced usual care.
Hypothesis 3b: Caregivers of patients randomized to Bridge will have decreased caregiver 
burden, and greater improvement in caregiving mastery, engagement in cancer care, and 
satisfaction with care, compared to caregivers in enhanced usual care.
4.2 Study Design
Conducting the Randomized Controlled Trial (Months 3-39): Over 3 months, we will 
pilot the randomized trial procedures with 3 patients in each arm (n=6) and their caregivers. Over 
the next 33 months, we will conduct a RCT (n=120) to compare the impact of the Bridge model 
with enhanced usual care on disruptions in cancer care (primary outcome). We selected enhanced 
usual care as the control to ensure that if a patient screens positive for SMI, that diagnosis is 
shared with the treating oncologist. We will use qualitative and quantitative methods to assess 
cancer treatment, psychiatric symptoms, engagement in cancer care, and care utilization, while 
gathering feedback from stakeholders on their intervention.
Primary Outcome: Our primary outcome is the proportion of patients who 
experience clinically relevant disruptions in cancer care (defined as at least one delay to 
cancer diagnosis or treatment, deviation from stage-appropriate cancer treatment, or 
interruption in planned treatment) within 6 months of study enrollment. The study team 
previously operationalized the process of identifying cancer care disruptions from the EHR in a 
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cohort of patients with breast cancer and schizophrenia.14 Study investigators will apply that 
framework and NCCN guidelines to create metrics for lung, gastrointestinal, and head/neck 
cancer that will be reviewed by disease-center specific oncologists to define clinically relevant 
delays, deviations from stage-appropriate treatment, and interruptions. Trained study staff will 
use the metric to assess for cancer care disruptions via EHR review at 24 weeks and extract a 
summary of cancer care. A consensus panel of disease-specific oncologists who are blinded to 
intervention arm will review all patients at 24 weeks of care and evaluate for disruptions. Two 
disease-center specific oncologists will review, and if disagreement, the third oncologist will 
resolve the discrepancy. 
Secondary Outcomes and Covariates: We will also collect secondary outcome measures 
from patients and caregivers to assess psychiatric symptoms and illness, depression and anxiety, 
satisfaction with cancer care, activation, symptom burden, caregiver burden, and caregiver 
mastery. EHR and Administrative data: To explore the potential impact of Bridge on cancer 
treatment, we will assess the proportion of recommended cancer treatment received.  
4.3 Research Subject Selection
The research subject selection for patients, caregivers, and clinicians will remain the 
same as outlined in Section 3.3, with the exception of the changes below: 
Patient Participants:
The following inclusion criteria will be used:
1. Age ≥ 18 years old
2. Verbal fluency in English
3. Serious mental illness (Schizophrenia spectrum disorder, bipolar disorder, or major 
depressive disorder with prior psychiatric hospitalization) confirmed by study clinician at 
consent
4. Invasive breast, lung, gastrointestinal, or head and neck cancer (suspected or confirmed 
Stage I-III, or Stage IV cancer that can be treated with curative intent according to 
judgment by the oncologist.) 
5. Medical, surgical, or radiation oncology consultation at MGH Cancer Center within the 
past 8 weeks or a referral placed to the MGH Cancer Center and planned or 
recommended follow-up
The following exclusion criteria will be used: 
1. Have cognitive impairment severe enough to interfere with completing brief study 
assessments or providing informed consent (and does not have a guardian who can 
provide consent)
2. Recurrence of the same cancer type
NOTE: Trained oncology disease champions (oncologists or nurse practitioners) may consent 
patient and caregiver participants. These champions will be added as formal study staff with the 
appropriate CITI training certificates before they are able to consent.  
Caregiver Participants: 
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The following inclusion criteria will be used:
1. Age ≥ 18 years old
2. Verbal fluency in English
3. Identified or confirmed by the patient or guardian as a caregiver
4. Caregiver may be a relative, friend, or community mental health staff upon whom the 
patient relies for support and who is involved in their medical care 
5. The caregiver should either live with the patient or have contact with the patient once per 
week (on average)
6. Patient or guardian must provide permission to contact caregiver
NOTE: We would like to specify that the verbal consent process can be completed with 
participants in-person or via phone. 
Clinician Participants:
The following inclusion criteria will be used:
1. Are an oncologist or oncology nurse practitioner primarily providing direct oncology care 
at the MGH Cancer Center; or are a licensed community mental health clinician (e.g. 
psychiatrist, psychiatric nurse practitioner, psychologist, social worker, licensed mental 
health clinician, mental health nurse, or a prescribing primary care physician or nurse 
practitioner)
2. Had a patient who participated in the study 
NOTE: We would like to remove the clinician inclusion criteria from the eligibility 
checklist and no longer use it for clinician eligibility documentation. Since clinicians are not 
registered on Oncore for this study and many eligibility checklist items are not applicable, the 
study team (with IRB approval) will record clinician eligibility and consent internally. The ODQ 
approved eligibility checklist will continue to be used for patient and caregiver participants. 
4.4 Research Subject Entry 
Recruitment: Specifically, for the RCT: we will approach all oncology clinicians who 
have a patient enrolled in the study, whether on the Bridge or EUC arm. We will approach only 
the mental health clinicians who participate in the Bridge arm of the trial given they will be able 
to provide feedback on the intervention. 
Patients must be consented by a study clinician (licensed mental health clinician, such as 
a psychiatrist or case manager) or a trained physician (oncologist or nurse practitioner). Given 
the nature of the intervention and the primary outcome of impact on cancer care, we want to 
target patients who will receive additional cancer-directed treatment. Caregivers may be 
consented by any member of trained study staff.
All other recruitment procedures will follow Section 3.4, with the exception of the 
following added language:
 
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Referrals from Department of Mental Health funded sites: Participants may learn about the 
study through the patient fact sheet or recruitment letters (Appendices RCT B, C, & D) or 
through providers from Massachusetts General Hospital, or providers from Department of 
Mental Health (DMH) funded sites. Recruitment flyers may be distributed by providers in the 
context of a medical encounter, or they may be distributed at conferences geared towards the 
population of people with cancer and a mental illness. MGH and DMH providers may learn 
about the study through the clinician fact sheet (Appendix RCT A) and/or an email from the 
study staff outlining the aims and eligibility requirements for participants (Appendix RCT E). 
Providers may only refer patients they encounter as they provide usual clinical care for them; 
they will not screen medical records or access personal health information for the purposes of 
identifying eligible patients. If a patient is identified during normal clinical treatment by their 
provider as being potentially eligible for the study, the patient will be provided with a brief 
overview of the study through a patient fact sheet (Appendix RCT B). The patient may be 
offered the option to contact the study staff directly or may offer their provider permission to 
allow the study team to contact them. The provider may only collect the name of the patient and 
contact information, which will then be sent to the study staff at MGH. MGH study staff may use 
this contact information only to reach out to the interested patient to determine ultimate 
eligibility for the study. Though participants will be referred by providers from DMH funded 
sites, all recruitment and research activities will be conducted by staff at the MGH and all 
participants will be accounted for by the DF/HCC IRB. The research relationship between the 
DF/HCC and referring DMH funded sites will be collaborative and used only to identify 
potentially eligible patients to the study staff at the MGH, not to collect or analyze study data. 
Providers will not play a role in the study further than directing potential participants to the study 
staff at the MGH, unless the provider is identified as a caregiver or is a community mental health 
clinician for the patient that is engaged in the coordination of care and contacted for an exit 
interview. After potentially eligible patients are identified to the study team, a member of the 
study staff will contact the patient by phone or in person at an upcoming clinic visit to screen 
them for eligibility. Study staff will maintain confidentiality during any phone outreach and will 
not make any mention of the individuals’ mental illness or cancer diagnosis when leaving 
voicemails. 
Referrals from the MGH Collaborative Care and Community Engagement Program: We 
will receive referrals of eligible patients from the Collaborative Care and Community 
Engagement Program, an initiative based in Massachusetts General Hospital and run by the PI 
(Kelly E. Irwin, MD, MPH) and study clinician (Amy E. Corveleyn, MSW, LICSW). By 
receiving these referrals, we will be able to proactively identify patients from community mental 
health centers with the goal of approaching them to confirm eligibility at their first appointment 
in the MGH Cancer Center. Patient health information will not be screened for trial eligiblity 
until a referral to the MGH Cancer Center is placed. The study team may provide standard 
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language to assist community members in making the first appointment for the patient at MGH 
Cancer Center. 
Recruitment through the Partners Rally Recruitment Portal: We will submit a recruitment 
advertisement to the Partners Rally Recruitment Portal to allow interested and potentially eligible 
patients to send their contact information directly to the study team. The study team will then 
reach out to interested patients to assess fit and eligibility for the study. The study team will 
advertise the Partners Rally recruitment method for the study on social media sites and through 
email as well.
Enrollment: See Section 3.4, with the added language below:
We would like to correct the erroneous language in section 3.4 – the sentence reads: 
Patients who are judged to have capacity will then meet with the PI or study clinician to review 
the study protocol and consent form and obtain informed consent. We would like to remove 
“review the study protocol” as the physical protocol is not reviewed with participants or provided 
to them. Only the relevant study procedures are discussed. The sentence should now read: 
Patients who are judged to have capacity will then meet with the PI or study clinician to review 
the consent form and obtain informed consent.
Additional Language: Patients will be asked to complete baseline demographic and 
study questionnaires ideally in-person at the time of consent, or alternatively via email, 
telephone, or mail within two weeks of consent. An in-person BRPS assessment with a trained 
assessor will also be completed within this window. If it is not possible to complete the 
assessment in person, 18 questions of the BPRS may be completed via phone, or the entire 
assessment can be completed via video conferencing. Once baseline measures are completed, 
patients will be registered for study randomization. Please see Section 4.5.4 Description of Study 
Process for more details regarding instrument administration. 
Randomization: Patients will be randomized in a 1:1 fashion to Bridge or EUC, 
stratified by the presence of a caregiver, using a randomization sequence generated by the MGH 
Biostatistics Unit.  Patients must complete their baseline assessments before being randomized 
and if a caregiver is identified, he or she must consent within one week of the patient’s consent 
date. Bridge: The patient will receive a comprehensive assessment of barriers to care by the 
psychiatrist and/or case manager, co-management from oncology and psychiatry including at 
least one joint appointment with psychiatry and oncology, and follow up with a case manager to 
promote engagement in cancer care and strengthen communication. Participants will be asked to 
identify a family or community caregiver, but patients without caregivers can enroll in the trial. 
Study staff will then contact caregivers, explain the rationale for caregiver involvement and 
document consent for the trial.  
Enhanced usual care (EUC): Study staff will send a templated email to the treating oncologist 
(see RCT Appendix G) for every patient who consents to the trial, prior to randomization. The 
email informs the oncologists of the psychiatric diagnosis and available psychosocial services. 
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Study staff will also inform every patient and caregiver who consents of available psychosocial 
services through a flier (RCT Appendix BB).
Patient Retention: Based on attrition in the feasibility study (2 patients withdrew out of 
30), we estimate that approximately 12 patients will withdraw from the randomized controlled 
trail out of 120. Retention procedures will be followed as detailed in Section 3.4 (pending any 
changes detailed in the amendment)
4.4.1 Registration Procedures 
Like the open pilot, institutions will register eligible participants in the Clinical Trials 
Management System (CTMS) OnCore as required by DF/HCC SOP REGIST-101. When 
required by REGIST-101, registration must occur prior to the initiation of protocol-specific 
procedures or assessments. Participants in the brief three month pilot period (3 patients in each 
arm (n=6) and their caregivers; see page 22, paragraph 1) will not be registered in Oncore; this 
pilot is a review of procedures and is not included in statistical analysis. 
4.5 Methods
4.5.1 Selection of Instruments
Patient, caregiver, and clinician administered measures: the measures used will be the 
same as listed in Section 3.5.1, with the following changes:
Clinician Administered Measures 
1. The Brief Psychiatric Rating Scale (BPRS), 24 items, is used extensively in bipolar 
disorder, schizophrenia, and major depression, strong psychometric properties and 
sensitivity to change62 
Note: The BPRS will be audio-recorded and conducted by a trained study clinician. 
Patient Self-Report Assessments
1. Patient Activation Measure (PAM) is a 10-item measure of patient activation that 
captures ability to participate in cancer care, validated in patients with SMI and 
cancer76 
2. Health Leads Social Need Screening Toolkit is a validated brief screening tool that 
assesses the social determinants of health which focuses on remediable measures of 
material hardship linked with poor health outcomes78 
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Note: this measure will be included in the baseline assessment (given to both the Bridge 
and EUC arms). If a patient in the EUC arm screens positive, the study team will refer 
the patient to social work. 
3. Discrimination in Medical Settings Scale (DMS) is a 7-item measure of perceived 
discrimination in healthcare settings, adapted from the Everyday Discrimination 
scale.90 The measure has excellent internal consistency, reliability, and validity and 
has been used in medically-ill and underserved populations. We will pilot the DMS 
scale in patients with SMI. Note: the prompt has been altered to be more clear for 
participants completing the  measure on their own.
4. 5. Trust in Physician Scale (TPS) is an 11-item measure to assess a patient’s 
interpersonal trust in his or her physician.91 We will pilot the TPS in patients with 
SMI. Note: the prompt has been added as it was missing in the open pilot. We have 
also changed “primary care doctor” to “cancer care doctors” in the prompt.
Caregiver Self-Report Assessments
1. Caregiver Patient Activation Measure (CG-PAM) is a 10-item measure of caregiver 
activation and participation in the patient’s cancer care79
2. FAMCARE - 2 is a 17-item tool used to measure family satisfaction with advanced 
cancer care. FAMCARE – 2 is one of the main versions of the FAMCARE Scale. 
FAMCARE-2 refers more to a team approach to care, references more symptoms than 
pain alone, and offers more response options compared to FAMCARE. Our study 
team has modified the question prompts to say “team” rather than “palliative care 
team”, as patients on study will not all be receiving palliative care.83
3. The Pearlin Mastery Scale is a 7-item measure of mastery, perception of being able 
to impact and have control over care, validated in caregivers of cancer patients81 
We have added a general prompt as this was missing in the open pilot.
Medical Record Review: See Section 3.5.1 (pending any changes in the amendment)
Intervention Feedback: We will gather patient, caregiver, mental health 
clinician(Bridge arm only) and oncology clinician (Bridge arm and EUC arm) perspectives on 
the feasibility, acceptability, and usefulness of the intervention and participation in the enhanced 
usual care arm by conducting brief semi-structured surveys (5-10 minutes) on the feasibility and 
usefulness of the intervention. The patient and caregiver exit surveys will occur during a 4 week 
period in the 12 week window, the mental health clinician exit surveys will occur at 1220 weeks 
post-baseline, and the oncology clinician exit surveys will occur at 20-32 weeks post-baseline. 
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4.5.2 Description of Intervention: See the edited table below. Note: The 
specified communication intervals are the minimum required from baseline to 12 weeks; 
additional communication is at the clinical discretion of the study team. If caregivers are no 
longer involved in the patient’s cancer care, clinicians will assess the need to continue to conduct 
outreach.
Note: Communication is defined as an attempted outreach via phone, email, or text. 
Note: A patient navigator has been added to the study team and will assist with the 
responsibilities of the psychiatrist and the social work case manager, including expanding our 
capacity to see patients in the community. The navigator will be trained in completion of the 
BPRS and have ongoing supervision by a social worker or other study clinician. The navigator 
has received clinical training in the psychiatric symptoms measured by the BPRS.
Assessment and Follow-Up
Communication
Case Manager/Social Work
1.Initial assessment (via 
phone or in-person) by 
study clinician of 
psychiatric symptoms and 
barriers to cancer care, 
note in EHR 
2. Recommendations emailed 
to oncologist, SW, and 
community mental health 
team at beginning and 
conclusion of study
3. Study staff review patient 
location daily for 
encounters
1. Study clinician or study navigator 
proactively reviews EHR weekly and 
communicates with patients bi-weekly
2. Study clinician  emails oncology 
clinicians monthly during intervention
3. Co-management: At least one joint visit 
between oncology and psychiatry or 
telephone discussion about cancer care 
management 
4. Psychiatrist and CM available by page
5. Direct communication established 
between community mental health 
clinicians and oncology team
1. Assess barriers to cancer care
2. Identifies family/community 
caregiver and establishes direct 
communication.
3. Conducts a caregiver risk 
assessment
4. Case manager or navigator 
communicates with caregiver 
monthly 
5. Bridges clinician-to-clinician 
communication 
During the 12-24 week period, for each patient the study team will conduct a monthly chart 
review, and a study clinician will communicate at least once with the patient’s oncology team, 
and communicate monthly with patients and caregivers.
4.5.3 Data Collection: See Section 3.5.3, and the following additional language:
Additional Language: All patient information, including audio recordings, will remain 
confidential and stored on Partners computers and in REDCap. All data and recordings will be 
labeled with a unique study ID number which will be assigned to participants at the time of 
enrollment, and which only the study team will have access to. All audio recordings will be 
transcribed verbatim, and the transcriptions will be stored on Partners computers. All audio 
recordings will be deleted from the recording device after they are transcribed and fully 
analyzed. Since these records necessarily contain patient identifiers, only study staff will have 
access to them. Identifiers such as name will only be used during the initial data retrieval process 
and can be destroyed once all data records have been obtained and data analysis completed.
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Post-Intervention
Data
Baseline 5-7 Weeks 12 Weeks - 2 weeks, 
+4 weeks
24  2 
weeks
Clinician-Administered Measures
Psychiatric symptoms (BPRS)
X
X
X
Psychiatric illness severity (CGI-S)
X
X
X
X
Psychiatric illness improvement (CGI-I)
X
X
X
Patient and Caregiver Self-Report
Depression and anxiety symptoms (PHQ-9, GAD-7)
X
X
X
X
Discrimination in Medical Settings (DMS)
X
Patient Self-Report
Satisfaction with cancer care (FACIT-TS-PS)
X
Patient Activation Measure (PAM 10)
X
X
X
X
Symptom burden (MDASI)
X
X
X
X
Trust in Physician Scale (TPS)
X
Resource utilization Questionnaire
X
X
X
Health Leads Social Needs Screening Toolkit 
X
Caregiver Self-Report
Caregiver Patient Activation Measure (CG-PAM 10)
X
X
X
Caregiver burden (Caregiver Reaction Assessment)
X
X
X
Caregiver mastery (Pearlin Mastery Scale)
X
X
X
Caregiver Satisfaction with Patient Care (FAMCARE 2)
X
X
X
Medical Record Review
X
4.5.4 Description of Study Process: Intervention administration and special 
concerns will follow the same guidelines in the RCT as the open pilot (Section 3.5.4). Please see 
below for revised study instrument administration and compensation sections:
Study Instrument Administration 
Patients will complete the baseline survey in the outpatient clinic, in the infusion suite, or 
during hospitalization. The baseline, and all future study assessments will occur in a private 
consultation room or office space to ensure patient confidentiality. If patients and/or caregivers 
refuse or are unable to complete the questionnaires in person, they will be permitted to do so via 
email or phone with a study clinician or trained research assistant. The RA will contact patients 
(in person or via telephone) no more than 4 times over the course of two weeks to remind them 
to complete and return the surveys. If study participants fail to complete to surveys within the 
expected window, we will report the data as missing and document the reason for incompletion. 
Patients must be approached and consented to the study within 8 weeks of oncology 
consultation at MGH. If the patient consents to the study, they must complete the baseline 
assessments (clinician and self-report assessments) within two weeks. The baseline BPRS will be 
audio-recorded (after obtaining written consent for audio recordings) and conducted by a trained 
study clinician. If no caregiver is identified for the patient, the patient will then be randomized in 
a 1:1 fashion to either the Bridge arm or the EUC arm, and registered in OnCore. If a caregiver is 
identified and the patient gives permission to contact a caregiver, the study team will reach out to 
consent the caregiver. The caregiver must consent to the study within one week of the date the 
patient consented. If the caregiver does not consent to the study within this one week window, 
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the caregiver is no longer eligible to participate. Once the patient completes baseline 
assessments, the patient and caregiver will be randomized together to either the Bridge arm or 
the EUC arm and the patient will be registered in OnCore. The caregiver has two weeks to 
complete the baseline assessment from the date of caregiver consent. When the caregiver 
completes the baseline assessment, he or she will be registered in OnCore. If the caregiver fails 
to complete the baseline assessment within the two-week window from consent, he or she will no 
longer be eligible to participate in the study. If the patient identifies a change in their primary 
caregiver throughout the course of the study, the study team reserves the right to enroll the new 
caregiver in the study and collect their reported outcomes, per the PI’s discretion. The study team 
will document the date of the caregiver switch in the Participant Tracking Log. This change does 
not prevent the study team from providing support to or collecting data from the previous 
caregiver, per clinical judgement.
The caregiver risk assessment must be completed by the case manager (if unavailable, 
may be conducted by another study clinician) in-person or via phone with the caregiver within 
one month of the caregiver baseline completion. With permission, the caregiver risk assessment, 
the joint visit with the oncology team, all BPRS assessments, and the initial clinical assessment 
with the patient (caregiver may or may not be present) will be audio-recorded for data analysis 
and fidelity purposes. We will obtain written consent from patients and caregivers for all study 
recordings before their first recorded assessment. At the time of each subsequent recording, the 
study staff will verbally re-confirm permission to record the current assessment or visit. We will 
record at least 85% of all joint visits and assessments, excluding the baseline BPRS, which 
occurs prior to patient randomization, due to the difficulty of obtaining written consent for audio-
recording during a phone consent. These recordings will be reviewed by the principal 
investigator and trained study staff to ensure key domains are covered. Feedback and targeted 
training will be provided weekly to study clinicians until fidelity is achieved.
In the event that a participant consents to the study over the phone but will not be coming 
into MGH in the near future, study staff will begin the electronic informed consent (EIC) process 
for audio-recording study assessments and visits. Participants will be asked to provide verbal 
permission and a preferred email address to be sent an email with a link through REDCap. The 
REDCap link will direct participants to an encrypted REDCap portal; the Electronic/Paperless 
Consent Template Project will be used. This process begins with the participant verifying their 
date of birth and full name in order to enter the portal. Additionally, this portal will have the 
electronic (paperless) consent form, exactly identical in content to the paper version, to guide the 
participant through the consent discussion with study staff over the phone. At any point, if a 
participant would prefer to receive a hard copy of the consent form, the EIC process will stop 
and study staff will send the participant two copies of the consent form in the mail with a prepaid 
envelope to send it back. The participant will be given ample opportunity to ask questions and 
take their time to consider if they want their study assessments to be recorded. From there, 
participants will digitally sign and date the consent form for recordings. The study staff will then 
sign and date the consent form as the consenting investigator and send a digital or paper copy of 
the signed consent form per the participant’s preference, sent via Send Secure email if digitally 
or informed and given the opportunity to opt-out of Send Secure using the Partners Send Secure 
opt-out language.
Subsequent assessment windows for both patients and caregivers will be anchored on the 
date of the patient’s baseline completion. The 6-week assessment must be completed 5-7 weeks 
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after baseline. The 12-week assessments must be completed 10-16 weeks after baseline. The 24 
week assessments (patients only) must be completed 22-26 weeks after baseline. The 12-week 
exit surveys for patients, caregivers, and mental health clinicians, and the 24-week exit survey 
for oncology clinicians, can be completed via email, phone, or in person, whichever is least 
burdensome. Responses will be recorded and transcribed verbatim. Upon study completion, the 
study team will thank each patient and caregiver participant with a handwritten card. Mental 
health clinicians must complete exit surveys from 12- 20 weeks after the patient baseline 
assessment, and oncology clinicians must complete exit surveys from 20-32weeks after baseline. 
Compensation
Due to the added 24 week time point for patient participants, the $50 remuneration will 
be distributed as follows: $20 after completion of baseline questionnaire and clinician 
assessment; $10 after completion of 12 week questionnaire, exit interview, and clinician 
assessment; $20 after completion of 24 week questionnaire and clinician assessment.
Remuneration for caregivers and clinicians will remain the same as stated in the open 
pilot compensation section (3.5.4).
NOTE: Patients and caregivers will be given the option to accept, decline, or donate their 
remuneration back to the program.
4.5.5 Adverse Reactions and Their Management: 
Anticipated Reactions has been revised to the following:
As this is a behavioral study, there are no ingested medications, and no biomedical 
procedures. It is unlikely that participants will be at any risk for physical harm because of study 
participation. Should participants exhibit or express distress or anger, they will be reassured by 
the Research Assistant that they need not answer any questions which they find upsetting. They 
will also be reminded that study participation is voluntary. If participants remain distressed, both 
the Principal Investigator and the oncology team will be notified. Should several participants 
express distress over an individual item, the research team will review the questionnaire and 
contact the IRB to consider removing it from the study.
Participants who endorse > 0 on the PHQ-9 item #9 (“thoughts that you would be better 
off dead or hurting yourself in some way”) or endorse ≥ mild suicidality (3) on the Brief 
Psychiatric Rating Scale will be assessed by a licensed mental health clinician (the PI Kelly 
Irwin, MD, MPH a licensed psychiatrist; study clinician Amy Corveleyn, MSW, LICSW; co-
investigator April Hirschberg, MD, a licensed psychiatrist; or other designee). The clinician will 
evaluate the participant in-person or via phone to assess for suicidal ideation, determine if the 
patient is at any risk for self-harm, or initiate further intervention for his or her symptoms. Study 
clinicians will tailor individualized follow-up via mail, phone, or text with participants as 
deemed clinically necessary.  
If a participant completes the study questionnaires with a research assistant or online 
through the secure REDCap portal, a study staff member will score the responses and notify a 
licensed mental health clinician on study staff or designee who will follow-up within 72 hours of 
assessment receipt. If a participant endorses a score greater than 0 on question #9 of the PHQ-9 
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and is unable to be reached by the study team for a follow-up risk assessment within 72 hours, 
the study clinician will reach out to an appropriate member of the healthcare team or an 
emergency contact to notify them of this response and decide further steps to ensure participant 
safety.
Reaction Management has been revised to the following:
If distressed participants require further outpatient psychiatric services or are at risk for 
self-harm requiring hospitalization, the PI (a licensed psychiatrist), study clinician (a licensed 
social worker) or designee (a doctoral-level psychologist or psychiatrist) will make the necessary 
referrals for treatment, or be in communication with the participants’ oncology and community 
mental health team. The participant will remain on study and be referred to a higher or more 
intensive level of care as appropriate.
Note: these procedures will be consistent for participants in both arms of the randomized trial. 
Additional Language: Identification of adverse events may come through notification from the 
study participant, caregiver, clinician, or from review of the EHR. In such circumstances, the PIs and 
investigative team will follow the following procedures:
Serious Adverse Events: The study team will adhere to the Department of Mental Health 
guidelines on adverse event reporting. However, given that this study is a minimal risk 
intervention, we do not anticipate any study-related events meeting the FDA definition of a SAE (i.e., 
any fatal event, immediately life-threatening event, permanently or substantially disabling event, 
event requiring or prolonging inpatient hospitalization, or any congenital anomaly). This study 
population is comprised of individuals diagnosed with cancer and a serious mental illness who 
frequently experience disease worsening, high rate of symptoms, and hospitalizations from the 
underlying disease and/or side effects of treatment. Therefore, regular fluctuations in cancer-related 
or mental health-related symptoms, disease worsening, hospitalizations, emergency department 
visits, and even deaths are to be expected throughout the study, and we will not consider or report 
such events as SAEs in this trial. 
Non-Serious Adverse Events: The IRB will be provided with unblinded summaries of study related 
non-serious adverse events by treatment group at the continuing reviews. These reports will include 
types of events, severity, and treatment phase. 
4.6 Statistical Analysis: 
4.6.1 Primary and Secondary Endpoints
Our primary outcome is the proportion of patients who experience clinically relevant disruptions 
(defined as at least one delay to cancer treatment initiation, deviation from stage-appropriate 
cancer treatment, or interruption in planned treatment) within 6 months of study enrollment. The 
study team previously operationalized the process of identifying cancer care disruptions from the 
EHR in a cohort of patients with breast cancer and schizophrenia.84 Based on that validated 
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framework and NCCN and Commission on Cancer guidelines, study investigators met with 
thoracic, gastrointestinal, and head and neck oncologists (medical, surgical, and radiation 
oncologists) and developed metrics for cancer care disruptions based on cancer type, stage, and 
other clinical characteristics. These metrics included: delays to treatment initiation, deviations 
from stage-appropriate treatment, and interruptions in cancer treatment (e.g. > 8 weeks between 
surgery and post-operative chemoradiation for squamous cell head and neck cancer). The research 
team and consensus panel of oncologists operationalized disruptions conservatively (clearly 
different from standard of care), and acknowledged that it may be warranted to modify treatment 
due to comorbidity or treatment toxicity; study staff will track treatment toxicity documented by 
the oncology team. Study staff will use the metric as a checklist to extract a summary of cancer 
treatment received at 24 weeks. Subsequently, a consensus panel of disease-center specific 
oncologists blinded to study arm will review all summaries and evaluate for disruptions. Two 
disease-center specific oncologists will review independently, and a third oncologist will resolve 
any discrepancy. This consensus panel approach has been utilized for review of clinically relevant 
oncology outcomes. 
EHR and Administrative data: To explore the potential impact of Bridge on cancer treatment, we 
will assess the proportion of recommended cancer treatment received.  Study staff will review 
the initial cancer treatment plan, extract the amount of radiation and chemotherapy received at 24 
weeks, and calculate the percentage of recommended radiation and chemotherapy received. Staff 
will track documented reasons for missed treatment (e.g. toxicity). We will assess time to cancer 
treatment (interval from initial oncology consultation to cancer treatment initiation), missed 
oncology appointments, ED visits, and hospitalizations. Although most cancer care will occur 
within one system, psychiatric visits may occur outside MGH and would not be captured by the 
EHR. Therefore, we will link data from the Massachusetts All Payer Claims Database (APCD) 
on outpatient and inpatient claims for study participants. Such linkages require partnership with 
state agencies; Dr. Sanders, medical director of the Massachusetts DMH, supports these efforts
4.6.2 Sample Size and Power Calculation 
We used our previous study results along with published rates of patients with SMI and cancer 
who receive appropriate cancer care to estimate the detectable effect size of this RCT. Given 8% 
attrition in our feasibility study, we will estimate 10% attrition in the RCT to account for 
randomization procedures. We will target an enrollment of 120 patients for a sample size of 108 
completers. With a sample size of 108 completers, 50% disruptions in enhanced usual care, and 
25% cancer disruptions in Bridge, we will have at least 80% power to detect a significant 
difference between Bridge and EUC using a two-tailed Fisher’s exact test with an alpha of 0.05.  
Based on enrolling 30 patients in < 5 months in the feasibility study, we estimate that we will 
randomize at least 120 patients in 33 months (1-2 patients/week) accounting for a lower consent 
rate given the feasibility study was not randomized. Based on our feasibility study, we estimate 
that two-thirds of the 120 patients will identify a caregiver, resulting in a sample size of 80 
caregivers, and 72 caregivers who complete the intervention. Based on our experience in the 
feasibility study, we estimate that we have a sufficient sample size of patients and caregivers to 
detect a clinically meaningful difference.
4.6.3 Stratification factors and intervention allocation plan for randomized 
studies:
We will stratify by presence of caregiver to ensure equal representation of caregivers in the 
Bridge and EUC arms. 
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4.6.4 Stratification factors and their impact on design.
We will stratify by presence of caregiver to ensure equal representation of caregivers in the 
Bridge and EUC arms.  We have chosen to stratify by presence of a caregiver because having a 
caregiver involved could be related to the impact of the intervention on disruptions in cancer 
care. 
4.6.5 Analysis Plan:
 
Aim 2: To assess the impact of the Proactive Psychiatry Consultation intervention (Bridge) 
on cancer care 
Hypothesis 1: Compared to enhanced usual care (n=60), patients randomized to Bridge (n=60) 
will be less likely to experience cancer care disruptions (delays to treatment initiation, deviations 
from stage-appropriate treatment, and interruptions), have shorter time to cancer treatment 
initiation, and have improved healthcare utilization (fewer missed oncology appointments and 
decreased unplanned acute care).
Prior to analysis, we will assess the extent and pattern of missing data (e.g. if at random) and if 
missing ≥ 5%, we will consider using missing imputation techniques (e.g., EM algorithm, multiple 
imputation) to augment data. Given our primary outcome is based on EHR review, we do not 
anticipate missing data. Further, we anticipate low rates of missing data for patient-reported 
outcomes given rare missing data in the pilot (8%), and exclusion of patients with advanced 
cancer. Our primary outcome is the proportion of patients who experience at least one clinically 
relevant disruption in cancer care within 6 months according to the consensus panel of disease-
specific oncologists. We will use logistic regression to compare the proportion of patients who 
experience disruptions in cancer care in the Bridge and EUC arms along with baseline covariates 
that may be imbalanced between study groups (e.g., sex, age, cancer type and stage), while not 
overfitting the model. We will use Cox Proportional Hazards modeling to assess the impact of the 
Bridge vs. EUC on time to cancer treatment. With respect to proportion of recommended cancer 
treatment received, missed appointments, ED visits, and hospitalizations, we will use appropriate 
tests (e.g., independent-samples t-test, nonparametric Wilcoxon rank-sum test, Poisson) 
according to the outcome distributions.  Power Analysis: We used our previous study results along 
with published rates of patients with SMI and cancer who receive appropriate cancer care to 
estimate the detectable effect size of this pilot RCT. With a sample size of 108 patient completers, 
50% disruptions in EUC, and 25% cancer disruptions in Bridge, we will have 82% power to detect 
a significant difference between Bridge and EUC with an alpha of 0.05. 
Aim 3: To assess the impact of Bridge on patient and caregiver-reported outcomes 
Hypothesis 2a: Patients randomized to Bridge will have greater improvement in psychiatric 
symptoms, engagement in cancer care, and satisfaction with cancer care compared to patients 
in enhanced usual care.
Hypothesis 2b: Caregivers of patients randomized to Bridge will have decreased caregiver 
burden, and greater improvement in caregiving mastery, engagement in cancer care, and 
satisfaction with care, compared to caregivers in enhanced usual care.
With the longitudinal data structure, we will use linear mixed models to examine change between 
groups in psychiatric symptoms (BPRS). We will explore differences in depression and anxiety 
symptoms (PHQ-9, GAD-7), patient engagement (PAM) and cancer symptoms (MDASI). The 
linear mixed models will allow us to account for dependency among means over time and control 
for demographic and clinical factors when examining change between groups across time points 
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(baseline, 6, 12, and 24 weeks for patients, baseline, 6, and 12 weeks for caregivers). Based on 
our pilot, we estimate that 2/3 of the 120 patients will identify a caregiver, yielding a sample size 
of 80 caregivers.
4.6.6 Missing Data Issues 
Prior to analysis, we will assess the extent and pattern of missing data and if missing ≥5%, we 
will consider using missing imputation techniques (e.g., EM algorithm, multiple imputation) to 
augment data. The analyses will initially focus on the study completers to estimate the effect of 
care delivery intervention in patients with serious mental illness and cancer who complete the 
intervention without imposing assumptions about missing data. We will also use the intention-to-
treat principle with all randomized subjects, conducting sensitivity analyses to explore how 
various assumptions about missing data and differences between completers and non-completers 
affect the estimated outcomes. If data appear to be missing at random, we will employ multiple 
imputation methods. However, if we find that patients do not complete the study because of 
disease worsening, suggesting missing data are not random, we will employ maximum likelihood 
estimation from incomplete data, under the direction of our biostatistician, Dr. Yuchaio Chang.
5.0 PART 3 – Delphi Consensus Method
5.1 Aim: To develop metrics for disruptions in cancer care based on cancer type, 
stage and other clinical characteristics.
5.2 Study Design:
This is a descriptive, iterative study conducted at four times points using the Delphi 
Method.85 The first questionnaire for each cancer specialty will consist of open-ended questions 
measuring how oncology clinicians would define a clinically significant disruption in care for 
under-represented and underserved populations. 
A second questionnaire will be generated based on the results of round one analysis. This 
will include a sample metric for each cancer specialty, compiled by the PI. Each item on the 
metric will be ranked from 1 (irrelevant) to 5 (relevant) for the second questionnaire of the 
Delphi process. The survey will contain the list of items to be ranked followed by an open-ended 
question at the end of the survey to provide panelists a way to suggest additional items to be 
considered in the third questionnaire.85
The third questionnaire will be generated based on the results of the second round of 
analysis. Each panelist’s previous response, as well as the group median, will be displayed 
alongside each survey item. Panelists will be asked, but not required, to provide reasoning for 
any survey question they responded to that was discordant with the majority. Any additional 
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survey items suggested in the open-ended response of the previous questionnaire will also be 
included for consideration if the study team deems them appropriate. Survey results will be 
collected and analyzed in a process identical to the one performed after round two. 
The final questionnaire will include the updated group median and individual ratings will 
then be sent to all panelists. The results of the Delphi procedure will be the creation of 
specialized metrics to identify clinically relevant delays, deviations from stage-appropriate 
treatment, and interruptions in care for breast, thoracic, gastrointestinal, and head and neck 
cancer.
5.3 RESEARCH STUDY SELECTION
5.4 RESEARCH STUDY ENTRY
From our own clinical practice and research experience, we will select oncology 
clinicians from academic institutions or community health centers who we believe to have 
significant expertise in either breast, thoracic, gastrointestinal, or head and neck specialties. Once 
100 prospective panelists have been identified (25 for each cancer specialty), an introductory 
email will be sent from the PI to each potential panel member detailing why the individual was 
contacted and a brief overview of the Delphi method (Delphi Consensus Method Appendix A). 
The email will also convey the estimated time commitment required, study duration, and 
compensation ($100.00) offered for their active participation. An emailed response affirming 
interest in the study from the prospective panelist, will both confirm study participation and 
denote informed consent. We expect at least 20 members out of the 25 initially contacted for 
each cancer specialty to agree to participate in the study, with 15-25 panelists being standard for 
the Delphi process.
Clinician participants will not be registered in Oncore, nor will they be counted towards 
the overall accrual goal for the study. 
5.5 METHODS
Inclusion Criteria
Exclusion Criteria
1. Oncology clinicians in fields related to medical, 
surgical, or radiation oncology, specializing in 
either breast, thoracic, gastrointestinal, or head 
and neck cancer, and providing care at an 
academic institution or community health center.
1. Unwilling or unable to participate in all four 
rounds of questionnaires
2. Verbal fluency in English
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5.5.1 SELECTION OF INSTRUMENTS
The initial iterations of the metrics used for each cancer type will be created by the PI, 
and reviewed by oncologists with experience in the four cancer types. These metrics include: 
delays to treatment initiation, deviations from stage-appropriate treatment, and interruptions in 
cancer treatment (e.g. > 8 weeks between surgery and post-operative chemo-radiation for 
squamous cell head and neck cancer). We will administer several demographic questions with 
items pertaining to a participants’ age, years practicing, extent of experience with and comfort 
treating patients with cancer and under-represented populations. The estimated time to complete 
each round of questionnaires will be 20 minutes.
5.5.2 DESCRIPTION OF INTERVENTION
This is a descriptive, iterative study conducted at four times points using the Delphi 
Method.
5.5.3 DATA COLLECTION
Data will be collected from survey responses from expert participants regarding clinically 
relevant delays, deviations from stage-appropriate treatment, and interruptions in cancer care. All 
precautions to safeguard participant information and confidentiality will be followed as stated in 
section 4.5.3. 
5.5.4 DESCRIPTION OF STUDY PROCESS
Information will be collected from participants at four time points through email 
correspondence. All emails containing the electronic links to questionnaires will be sent by the 
PI or RA using a structured template based on the results of the former iterations of 
questionnaires. Each questionnaire should take no longer than 20 minutes to complete.
Compensation: We will offer participants a $100 check for remuneration at study 
completion of all four rounds of questionnaires. Participants will have the option to opt out of 
remuneration if that is their preference.
5.5.5 ADVERSE REACTIONS AND THEIR MANAGEMENT
Reporting Adverse or Unanticipated Events:  We do not anticipate any adverse reactions 
as a result of study participation.  The PI will be responsible for ensuring that any adverse events 
are reported to the DF/HCC IRB, as necessary. Study staff will report adverse events to the IRB 
as soon as they are discovered and discussed with the PI or designee (within 24 hours). The PI 
will be responsible for cataloguing and tallying adverse events, and will report these events to the 
DF/HCC IRB. The necessary written forms provided by the DF/HCC IRB will be used to report 
adverse events.
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Anticipated Reactions:  We do not anticipate any adverse reactions as a result of study 
participation. Emails containing electronic links to questionnaires will assure participants that 
they may skip any questions they wish.
Reaction Management:  The PI will be available to discuss any concerns that arise from 
completing the surveys. If study participants become distressed while completing the survey, the 
PI, who is a psychiatrist, will be available to discuss any concerns.  
5.6 STATISTICAL ANALYSIS
This study involves data collection at four time points. We will use descriptive analyses 
to characterize the sample at round one, and will continually use qualitative analyses to explore 
oncologist’s perceptions about the cancer care disruptions.  
Study Endpoints: The endpoint will be the four metrics that emerge from the expert 
panelists on cancer care disruptions. 
Sample Size: We expect at least 20 members out of the 25 initially contacted for each 
cancer specialty to agree to participate in the study (total N=80), which will be a sufficient 
sample size as 15-25 panelists are standard for the Delphi process.86
6.0 PART 4 – Qualitative Interviews
6.1 AIM: To elucidate stakeholder perceptions about the core intervention components 
and approaches for overcoming barriers to implementation and dissemination of the 
Bridge intervention within the cancer center and the community.
6.2 STUDY DESIGN
This is a descriptive study at a single time point. We will use qualitative assessment 
methods to characterize the sample and explore participant perceptions regarding barriers to 
implementation and sustainable dissemination of the Bridge intervention in community settings. 
We will conduct qualitative interviews with 30 stakeholders (10 patients, 10 caregivers, and 10 
mental health clinicians) to learn what would be most helpful in replicating the Bridge 
intervention at other sites.
Compensation: We will offer participants $30 (in cash or check form, depending on 
preference) for remuneration after completing the qualitative interview. Participants will have the 
option to opt out of remuneration if that is their preference
6.3 RESEARCH STUDY SELECTION
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Patient Participants:
The following inclusion criteria will be used:
1. Participated in the 24-week Bridge Study
2. Completed the Bridge Study intervention within the last 18 months
3. Capacity and willingness to complete a 30-minute semi-structured, audio-recorded 
interview
Caregiver Participants: 
The following inclusion criteria will be used:
1. Age ≥ 18 years old
2. Verbal fluency in English
3. Previously identified or confirmed by the patient or guardian as a caregiver
4. Caregiver may be a relative, friend, or community mental health staff upon whom the 
trial participant/patient relies for support and who is involved in their medical care 
5. The caregiver should either live with the patient or have contact with the patient once 
per week (on average)
6. May or may not have been enrolled as a caregiver in the Bridge Study
7. Regardless of whether they were enrolled as a caregiver in the Bridge Study, the trial 
participant for whom the caregiver provided support for must have completed the 
intervention within the last 18 months 
8. Capacity and willingness to complete a 30-minute semi-structured, audio-recorded 
interview
Clinician Participants:
The following inclusion criteria will be used:
1. Are a licensed community mental health clinician (e.g. psychiatrist, psychiatric nurse 
practitioner, psychologist, social worker, licensed mental health clinician, mental health 
nurse, or a prescribing primary care physician or nurse practitioner)
2. Had at least one patient who participated in the study 
a. RESEARCH STUDY ENTRY
We will utilize purposive sampling of patient participants, caregiver participants, mental health 
clinician participants (including a mixture of prescribing and non-prescribing mental health clinicians) to 
ensure thematic saturation.” Study staff trained in qualitative methods will contact eligible 
participants via phone, email or in-person to consent them to the qualitative interview and 
schedule a time to conduct the interview. Study staff will outreach to potential participants no 
more than three times to request participation in the interview. We are requesting to waive the 
written documentation of participants’ informed consent and in its place, secure their verbal 
consent to participate the qualitative interviews to provide feedback that will be used to refine 
the Bridge Intervention. This waiver would grant us the ability to accept verbal consent in lieu of 
the traditionally signed consent form. Our research presents no more than minimal risk of harm 
to subjects, and does not involve procedures where written documentation of consent would 
normally be required outside of the research context. Participants will be reminded during the 
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data collection process that their participation is voluntary, and that they have the right to 
withdraw from the study at any time. In addition, we will inform the participants about the 
confidentiality measures that the research group will take during the process. Only members of 
the research team will have access to the data, and the recorded responses will not contain 
identifiable or confidential information. The verbal consent process will include pertinent 
information on study design, risks and benefits, and voluntary nature of the research and 
confidentiality. The consent process will be executed in a manner consistent with the IRB 
approved protocol, and the most recent version of the IRB-approved protocol will be used. 
Participants will be encouraged to review the Qualitative Interview Information Sheet in its 
entirety, before verbally consenting. Participants will be given a copy of the Qualitative 
Interview Information Sheet to keep.
Patients and caregivers: Individuals will provide their written consent to be audio-
recorded (if they have not already signed the Participant Written Consent for Recordings form 
during the study, see Appendix L) during the qualitative interviews, as these recordings will be 
utilized to gather feedback to systematically strategies to implement Bridge effectively in the 
community. The consent process and the interview will be performed by a study staff member.
Clinicians: Clinician participants will provide verbal consent only.
METHODS
6.5.1
SELECTION OF INSTRUMENTS
Our interview guide comprises broad questions about stakeholders’ understanding of 
barriers and facilitators to cancer care for individuals with severe mental illness, from initial 
diagnosis to end of life. Our interview guide was reviewed by psychiatrists and psychologists 
with experience in qualitative interviewing and research concerning cancer-related disparities. 
The estimated time to complete the qualitative interview is 30 minutes.
6.5.2
DESCRIPTION OF INTERVENTION 
This is a descriptive study at a single time point.
6.5.3
DATA COLLECTION
Data will be collected from interviews of participants about implementation of the Bridge 
intervention for patients with severe mental illness and cancer. The interviews will be audio-
recorded and transcribed for further qualitative analysis.
To safeguard participant information and confidentiality, all data will be stored in locked 
cabinets at MGH as well as password-protected computer files, accessible only to trained study 
staff. Participants' data will be identified by an ID number only, and a link between names and 
ID numbers will be kept in a separate file under lock and key. Participants’ Social Security 
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Number/Individual Taxpayer Identification Number and address, which may need to be collected 
for the purposes of subject remuneration, will be kept in a separate password-protected computer 
file, and will be destroyed following completion of the study. 
6.5.4
DESCRIPTION OF STUDY PROCESS
Information will be collected from participants at a single time point. Interviews may be 
conducted by phone, virtual video-conferencing technology (e.g., Zoom) or in-person, and the 
method chosen will be based on the participants’ preference. All interviews will be conducted by 
study staff trained in qualitative interviewing methods using a structured guide (see RCT 
Appendix; pages 283-289 [Appendix HH] for patient interview guide, pages 290-300 [Appendix 
II] for caregiver interview guides, and pages 301-307 [Appendix JJ] for mental health clinicians). 
The interview will last approximately 30 minutes and will be completed in one study visit.  
We will recruit and consent 30 participants (10 patients, 10 caregivers [a mix of 
family/friends and community mental health clinicians], and 10 mental health clinicians).
Instrument Administration: The trained study staff member will use a semi-structured 
interview guide, including open-ended questions and response probes, to obtain comprehensive 
data collection and to clarify responses. These questions and response probes will inquire about 
participants’ experience with the Bridge intervention for individuals with severe mental illness 
and cancer, and the insights they gained from those experiences regarding barriers and 
facilitators to cancer care that may help to disseminate this intervention to other sites. The 
interview guide will be tailored to the type of participant (e.g., patient vs. caregiver vs. mental 
health clinician). We will also ask a few survey questions about participants’ demographics and 
experience with patients with severe mental illness and cancer. Participants will be asked to be 
frank and will be reminded that there is no right or wrong answer to any question. Participants 
will also be reminded that they may refuse to answer any questions that they choose.
Compensation: We will offer participants $30 (in cash or check form, based on 
preference) for remuneration.  Participants will have the option to opt out of remuneration if that 
is their preference.
6.5.5
ADVERSE REACTIONS AND THEIR MANAGEMENT 
Reporting Adverse or Unanticipated Events:  We do not anticipate any adverse reactions 
as a result of study participation.  The PI will be responsible for ensuring that any adverse events 
are reported to the DF/HCC IRB, as necessary. Study staff will report adverse events to the IRB 
as soon as they are discovered and discussed with the PI or designee (within 24 hours). The PI 
will be responsible for cataloguing and tallying adverse events, and will report these events to the 
DF/HCC IRB. The necessary written forms provided by the DF/HCC IRB will be used to report 
adverse events.
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Anticipated Reactions:  We do not anticipate any adverse reactions as a result of study 
participation. Emails containing electronic links to questionnaires will assure participants that 
they may skip any questions they wish.
Reaction Management:  The PI will be available to discuss any concerns that arise from 
completing the surveys. If study participants become distressed while completing the survey, the 
PI, who is a psychiatrist, will be available to discuss any concerns.
6.6 STATISTICAL ANALYSIS 
This study involves data collection at a single time point.  We will use descriptive 
analyses to characterize the sample and will use qualitative analyses to explore patients’, 
caregivers’, and mental health clinicians’ perceptions about the care of patients with serious 
mental illness and cancer, and how to best implement this care at other sites.  
6.6.1  STUDY ENDPOINTS
The endpoint will be the qualitative themes that emerge related to stakeholders’ 
perceptions of barriers and facilitators to cancer care for individuals with SMI, including cancer 
screening, diagnosis, treatment, communication among providers, and end-of-life care. 
6.6.2  SAMPLE SIZE AND POWER CALCULATION
We will recruit and consent 30 participants (10 patients, 10 caregivers, and 10 mental 
health clinicians).  Based on our team’s prior qualitative research experience, we believe that this 
sample size will be sufficient to achieve thematic saturation (i.e. the point at which no new data 
emerge).  
6.6.3  ANALYSIS PLAN
The interviews will audio-recorded and transcribed, and then coded to explore themes.  
Under the supervision of the PI, content analysis will be used to explore the themes identified. 
Major and minor themes will be extracted through an iterative process. Responses will be coded 
for frequency, intensity, and extensiveness. To ensure consistency (reliability), two study staff 
members will analyze the data independently. Kappa coefficients of agreement will be 
generated; discrepancies will be resolved by reviewing raw data. For quality assurance and 
accuracy (validity), the PI will review the notes from each interview. NVIVO software will be 
utilized in the thematic analysis.
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global impression scale among individuals with social anxiety disorder. Psychological 
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Dana Farber
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Sheehan D, Lecrubier Y, Sheehan K, et al. The Mini-International Neuropsychiatric 
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three depression measures in adult cancer patients. J Pain Symptoms Manage. 
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lung cancer: Effects of early palliative care. J Clin Oncol Off J Am Soc Clin Oncol. 
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Spitzer R, Kroenke K, Williams J, Lowe B. A brief measure for assessing generalized 
anxiety disorder. Arch Intern Med. 2006;166:1092-1097.
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measure (PAM): Conceptualizing and measuring activation in patients and consumers. 
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The M.D. Anderson Symptom Inventory. Cancer. 2000;89:1634-1646.
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Aoun S, Bird S, Kristjanson L, Currow D. Reliability testing of the FAMCARE-2 scale: 
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Irwin K, Park E, Shin J, et al. Predictors of disruptions in breast cancer care for 
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Technical Education. J Career Tech Educ. 2004;20(2).
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7.0 APPENDICES 
Part 1 - Open Pilot:
A. Clinician Fact Sheet 
B. Patient Fact Sheet 
C. Patient Recruitment Letter 
D. Caregiver Recruitment Letter 
E. Clinician Recruitment Email 
F. Clinician Approval to Approach Email
G. Telephone Script (Recruitment)
H. Patient Verbal Consent
I.
Caregiver Verbal Consent
J.
Assessment of Capacity to Participate in Clinical Research
K. Patient Baseline Questionnaire
L. Patient Interval Questionnaire
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M. Patient 12-week Questionnaire and Exit Feedback
N. Caregiver Baseline Questionnaire
O. Caregiver Interval Questionnaire
P. Caregiver 12-week Questionnaire and Exit Feedback
Q. Clinician-Administered Assessments
R. Oncology and Mental Health Clinician Email Consent
S. Oncology Clinician Exit Survey Bridge
T. Mental Health Clinician Exit Survey 
Part 2 - RCT: 
A. Clinician Fact Sheet 
B. Patient Fact Sheet 
C. Patient Recruitment Letter 
D. Caregiver Recruitment Letter 
E. Clinician Email (Recruitment) 
F. Clinician Approval to Approach Email
G. Clinician Email (Sent at Patient Consent)
H. Response to Direct Referral to Principal Investigator 
I.
Telephone Script (Recruitment)
J.
Patient Verbal Consent 
K. Caregiver Verbal Consent 
L. Participant Written Consent for Recordings
M. Assessment of Capacity to Participate in Clinical Research 
N. Patient Baseline Questionnaire 
O. Patient Interval Questionnaire 
P. Patient 12-week Questionnaire
Q. Patient 24-week Questionnaire 
R. Patient 12-week Exit Survey (Bridge arm only)
S. Caregiver Baseline Questionnaire
T. Caregiver Interval Questionnaire
U. Caregiver 12-week Questionnaire 
V. Caregiver 12-week Exit Survey (Bridge arm only)
W. Clinician-Administered Assessments 
X. Oncology and Mental Health Clinician Email Consent
Y. Oncology Clinician Exit Survey (EUC)
Z. Oncology Clinician Exit Survey (Bridge)
AA.
Mental Health Clinician Exit Survey 
BB.
Caregiver Risk Assessment Semi-Structured Guide (Family and Caregiver Versions)
CC.
Patient Initial Assessment Semi-Structured Guide 
DD.
Psychosocial Resources Flyer 
EE. 
Partners Rally Recruitment Advertisement
FF. Clinician Flyer
GG.
 Qualitative Interview Guide: Persons with cancer and mental illness
HH.
Qualitative Interview Guide: Caregivers of persons with cancer and mental illness 
II. Mental Health Clinician Qualitative Interview Guide 
JJ. Qualitative Interviews Verbal Consent
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Part 3 – Delphi Consensus Method
       A.   Clinician Introductory Email
A. Clinician Fact Sheet 
Proactive Psychiatry Consultation and Case Management
for Patients with Serious Mental Illness and Cancer
WHY: Individuals with serious mental illness (SMI) die nearly 25 years younger than the general 
population and are significantly more likely to die from cancer. 

Diagnosed with more advanced stage cancer

Less likely to receive recommended cancer treatment

Collaborative care can improve cancer outcomes but hasn’t been tested in patients with SMI
WHAT: Open pilot study combining screening, proactive psychiatry consultation at cancer diagnosis, 
and case management at the MGH Cancer Center.

Patient-centered care

Collaborative care strengthening communication among providers

Case manager linked to patient throughout cancer treatment
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B. Patient Fact Sheet 
Bridge: Early Psychiatry Consultation and Case Management 
Study for Patients with Cancer
Why participate in this study?

We’re conducting a study to understand if having a psychiatrist and case manager 
be part of your care team improves your cancer care. 
Who can participate? 
HOW: Enrollment
* If you know of a patient who may be eligible for this study please contact:

Kelly Irwin, MD: kedwards7@mgh.harvard.edu, (617) 643-4453

Catherine Callaway: ccallaway@mgh.harvard.edu, (617) 726-2297
* Dr. Irwin will meet with patients at their convenience to confirm eligibility, explain study procedures, 
and obtain consent.
Study Activities 
* After consent, participants will complete a psychiatric assessment with Dr. Irwin focused on 
decreasing symptoms and identifying barriers to care. Participants will complete a brief questionnaire 
at enrollment, 6 weeks, and 12 weeks. 
* Dr. Irwin will communicate recommendations to the participant’s oncology team and SW and remain 
available for ongoing consultation.
*A social work case manager will communicate directly with participants to promote self-
management, coordinate care, bridge communication with providers and document in medical record.
* Participants can receive up to $50 for participation in the study.
Additional Questions
* If you have or encounter additional questions about this study, please contact Kelly Irwin and/or 
Catherine Callaway.
WHO: Patients with SMI and recent diagnosis of cancer.

Diagnosis of psychotic disorder (schizophrenia, schizoaffective disorder), bipolar disorder, or 
major depressive disorder with prior psychiatric hospitalization 

Diagnosed with breast, lung, GI, or head and neck cancer within 8 weeks of initial oncology 
consultation at MGH

Are ≥ 18 years of age 

Have verbal fluency in English 
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
Patients who have recently been diagnosed with cancer and are getting their care 
at the MGH Cancer Center and have a history of mental health concerns, including 
depression, bipolar disorder, and schizophrenia. 
What does the study involve?

You will be connected to a psychiatrist and case manager who will be a part of your 
cancer care team.  

You will be asked to complete 3 brief surveys over 12 weeks and will be reimbursed 
$50. 

Participation involves no additional cost beyond usual care.
Do I have to participate?

Participation is completely voluntary and will not affect the care you receive at 
Massachusetts General Hospital.
What are the benefits of the study?

A psychiatrist and case manager will be available to you and communicate with 
your oncology team throughout your treatment. 

Your participation can help us learn how to provide better care for people with 
cancer and mental health concerns.
What are the risks of the study? 

This is a minimal risk study. 

You may experience distress when responding to certain survey questions. You do 
not have to answer any questions that you find upsetting, and you may stop 
participating in the study at any time.  

In every study, there is a risk for some loss of privacy regarding your health 
information. The study team will work to minimize this risk as much as possible. 
Questions?  Please contact Catherine Callaway (617) 726-2297, ccallaway@partners.org, or Dr. 
Kelly Irwin at (617) 643-4453, kedwards7@partners.org 
C. Patient Recruitment Letter
Date
Joan R, Patient
29 High Street
Boston MA
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Dear Mr./Ms. Patient,
I am writing to tell you about a research study that is being conducted at the Massachusetts General 
Hospital (MGH) Cancer Center by Kelly Irwin, MD, and a team of MGH researchers and clinicians.  You 
are receiving this letter because you have recently been diagnosed with lung, gastrointestinal, breast, or 
head and neck cancer and may receive cancer care at MGH. (Name of Dr/NP who gave permission to 
contact) believes you may be a good fit for this program and gave us permission to contact you.
  
The goal of this study is to understand if having a psychiatrist and case manager be part of your care team 
improves your cancer care.  
If you join this research study, you will have a psychiatrist and case manager as part of your cancer care 
team. 
It will take you about 3 months to complete this research study. You will be asked to complete a set of 
questionnaires with the help of a clinician at 3 points in time; at the first visit (30-45 minutes), at 6 weeks 
(10 minutes), and 3 month follow-up (20 minutes). Questionnaires can be completed via email, phone, or 
in-person, whichever you prefer.
Please contact the principal investigator Dr. Kelly Irwin, at (617) 643-4453 if you would like to learn 
more about the study.  Taking part in this research study is your choice and will not impact the care you 
receive at MGH.  If you do not want to participate in the research study, please call us within one week at 
(617)726-2297.  If we do not hear from you, someone from the study team will call to see if you might 
want to hear more about the research study.  
Attached is a fact sheet which will provide more information about the study. Thank you for thinking 
about being part of this research study.
Sincerely,
 
 
Oncologist/Cancer Clinic Tumor Site Study Liaison
Kelly Irwin, MD
Massachusetts General Hospital Cancer Center
(617) 643-445
D. Caregiver Recruitment Letter 
Date
Joan R, Caregiver
29 High Street
Boston MA
Dear Mr./Ms. Caregiver,
I am writing to tell you about a research study that is being conducted at the Massachusetts General 
Hospital (MGH) Cancer Center by Kelly Irwin, MD, and a team of MGH researchers and clinicians.  You 
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are receiving this letter because you have been identified as a caregiver for someone who has recently 
been diagnosed with lung, gastrointestinal, breast, or head and neck cancer and may receive cancer care 
or monitoring at MGH. (Name of Dr/NP who gave permission to contact) believes him/her may be a good 
fit for this program and (patient name) gave us permission to contact you.
  
The goal of this study is to understand if having a psychiatrist and case manager be part of a patient’s care 
team improves his/her cancer care. 
If you join this research study, a psychiatrist and case manager will be a part of (patient name)’s cancer 
care team and will be available to you throughout treatment. 
It will take you about 3 months to complete this research study. You will be asked to complete a set of 
questionnaires with the help of a clinician at 3 points in time; at the first visit (30-45 minutes), at 6 weeks 
(10 minutes), and 3 month follow-up (20 minutes). Questionnaires can be completed via email, phone, or 
in-person, whichever you prefer.
Please contact the principal investigator Dr. Kelly Irwin, at (617) 643-4453 if you would like to learn 
more about the study. Taking part in this research study is your choice and will not impact the care 
(patient name) receives at MGH.  If you do not want to participate in the research study, please call us 
within one week at (617)726-2297.  If we do not hear from you, someone from the study will be calling to 
see if you might want to hear more about the research study.  
Attached is a fact sheet, which will provide more information about the study.  Thank you for thinking 
about being part of this research study.
Sincerely,
 
 
Oncologist/Cancer Clinic Tumor Site Study Liaison
Kelly Irwin, MD
Massachusetts General Hospital Cancer Center
(617) 643-4453
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E. Clinician Recruitment Email
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients with 
Cancer
Dear Dr. ________,
Dr. Kelly Irwin is conducting an open pilot study focused on patients with both cancer and 
severe mental illness (SMI) including schizophrenia, schizoaffective disorder, bipolar disorder, 
and major depressive disorder with prior hospitalization. The goal of the study is to pilot patient 
and caregiver measures and refine an innovative model of care that incorporates proactive 
psychiatry consultation, collaborative care strengthening communication among providers, and 
engagement of a case manager at cancer diagnosis to optimize cancer care for patients with SMI. 
We are recruiting patients with SMI and a recent diagnosis of breast, lung, GI, or head and neck 
cancer (within 8 weeks of initial oncology consultation at the MGH Cancer Center). If you know 
of a patient who may be eligible for this study, please contact Dr. Irwin 
(kedwards7@mgh.harvard.edu, 617‐643‐4453) or Catherine Callaway 
(ccallaway@mgh.harvard.edu, 617‐726‐2297). Dr. Irwin will meet with patients at their 
convenience to confirm eligibility, explain study procedures, and obtain consent. If you have any 
additional questions about this study, please contact Dr. Irwin and/or Catherine Callaway.
Thank you,
F. Clinician Approval to Approach Email
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients with Cancer 
PI: Kelly E. Irwin, MD, MPH
Hello,
I am a research coordinator working with Dr. Kelly Irwin on an open pilot study to refine an 
innovative model of care that incorporates proactive psychiatry consultation and case 
management for patients with serious mental illness and a recent cancer diagnosis.  
Your patient(s) [name] [MRN] is (are) potentially eligible for the study and I would like to 
approach him/her/them during his/her/their upcoming appointment. Please let me know at your 
earliest convenience if I have your permission to approach this patient. If I do not hear from you, 
I will request your permission in person to approach this patient.
Study participation does not preclude you or the rest of the patient’s care team for consulting 
psychiatry per your clinical judgment. 
Please feel free to let me know if you have any questions or concerns.
Thank you,
Catherine Callaway
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G. Telephone Script 
Proactive Psychiatry Consultation Telephone Script
Hi is this (patient name)? My name is ___________ and I’m calling from Massachusetts General 
Hospital Cancer Center. I am calling about a letter that you may have received in the mail about 
a proactive psychiatry consultation program that you may be eligible for. Did you receive this 
letter?
NOT RECEIVED: I am happy to give you a brief overview if you have a couple of minutes. 
Would that be ok?
YES: Great. This program tests a new model of collaborative care that includes meeting 
with a psychiatrist and a social worker, known as our case manager, for patients at the 
MGH Cancer Center. We want to understand whether this model of care helps patients 
get the best possible cancer care. As part of the study, will be connected to a psychiatrist 
and a case manager who will be a part of your cancer care team. The psychiatrist and case 
manager will follow you for 3 months. We will ask you to complete a brief questionnaire 
at 3 different times during the study which will be coordinated with other appointments 
whenever possible, and can be completed via phone, email, or in-person. Your 
participation is completely voluntary and will not impact the care you receive at MGH.
NO: Is there a better time for me to call you back?
YES RECEIVED: That’s great to hear! Did you have a chance to look over it and think about if 
you might be interested in participating?
YES: Wonderful! Do you have any questions about the program?
NO: I am happy to give you a brief overview if you have a couple of minutes. Would that 
be ok?
YES: Great. This program tests a new model of collaborative care that includes
proactive psychiatry consultation and a social work case manager for patients at
the MGH Cancer Center. We want to understand whether this model of care helps 
patients in navigating cancer care. As part of the study, you will be connected to a 
psychiatrist and a case manager who will be a part of your cancer care team. It 
will take you about 3 months to complete the study, and we will ask you to 
complete a brief questionnaire at 3 different points of the study, and can be 
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completed via email, phone, or in-person. Of course, participation is completely 
voluntary and will not impact the care you receive at MGH.
NO: Is there a better time for me to call you back?
PATIENT WANTS TO ENROLL: Great. The next step is to arrange a time for you to meet 
with the psychiatrist or case manager and learn more about the study. We will try to coordinate 
the meeting with an upcoming oncology appointment. The total visit should take about one hour 
to complete. (If they have an upcoming appointment): I noticed you have an appointment on 
_____ (specific day), are you able to have the study appointment at that time? If not, when are 
you able to come in for this visit?
PATIENT INELIGIBLE/WANTS TO ENROLL: Unfortunately, you’re not eligible to 
participate in this study but we are happy to refer you to the oncology social worker.
PATIENT WANTS TO THINK ABOUT IT: Sure, I understand. Can I give you a call in the 
next week to see what you are thinking and answer any questions?
PATIENT REFUSES: No problem. You do not have to answer this question, but, if you are 
willing, may I ask why? Your response to this question will not affect your care in any way.
VOICEMAIL: Hello this message is for (patient name). Hi (patient name), my name is ____, 
and I’m calling from the MGH Cancer Center about a letter that you should have received in the 
mail about a program that you may be eligible for. Please give a call back at _____________ and 
let me know a good time to contact you.
Dana Farber
IRB NUMBER: 17-396
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H. Patient Verbal Consent 
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients 
with Cancer
Principal Investigator: Kelly Irwin, MD
Contact information: Call 617-643-4453 
Purpose of the Research
It is challenging to cope with cancer.  We are conducting a study to understand if having 
a psychiatrist and case manager as part of your cancer care team at the time of cancer diagnosis 
might improve your cancer care.  Many people with illnesses like major depression, 
schizophrenia and bipolar disorder face barriers to receiving high quality cancer care. It can be 
difficult to get to appointments, have many different doctors, and experience depression or 
worry. Better communication between the patient, the oncology team, and mental health 
providers may improve care. As for all patients, it is important for people with mental illness to 
have access to high quality cancer treatment that is patient-centered and coordinated. Having a 
case manager and psychiatrist at the cancer center may help patients to receive the cancer care 
that they need.
Study Information
We are asking you to participate in this study because we think you may benefit from 
this intervention. If you participate in this study, a psychiatrist and case manager will be a part 
of your cancer care team. They will be available to you and communicate with your oncology 
team throughout your treatment.  The case manager will help identify your needs, find 
resources, and communicate with the people who support you. 
You will complete a set of questionnaires (about 30 minutes) and have a study clinician 
review your mental health history and communicate it to your oncology team. At 6 weeks, we 
will ask you to complete a second set of questionnaires (about 10 minutes), and a third set of 
questionnaires in three months (about 20 minutes) with study staff. These questionnaires can 
be completed over the phone, by email, or in-person, whichever is least burdensome. We will 
also ask you to identify a caregiver who is part of your cancer care. This can be a family 
member, friend, or community-based staff member who comes to visits with you or talks with 
your doctors. Choosing not to identify a caregiver will not prevent you from participating in 
this study. 
Potential Risks and Discomforts
This study does not have any physical risks. You will not be injured or become 
physically sick because of participating in this study. Some of the items on the questionnaire 
may be upsetting. If any of the questions upset you, you can talk to your doctor or members of 
the study team. The research assistant and study clinician will be available to you throughout 
your participation in the study. You can also meet with our case manager or the principal 
investigator, a licensed psychiatrist, for additional support who can refer you to additional 
services as needed. If your responses indicate that you are in severe distress, a study clinician 
will call you to follow-up and assess your safety. At that point, you may be offered a referral to 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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appropriate services, which you may accept or decline. Your healthcare team may be notified of 
this referral. 
Your responses to the questionnaires will be written down on paper or completed 
online.  Your responses will not become part of your medical record, and they will not be seen 
by your care providers. We will also look at relevant parts of your MGH medical record, and 
store relevant data from your medical history. That data will be used only by study staff and 
will be protected by a password. Your identity will be kept confidential and we will be 
extremely careful to protect your privacy. If you receive the intervention, our psychiatrist and 
case manager will document their contacts with you in the medical record and share relevant 
recommendations with your oncology team. Taking part in this research study will not lead to 
added costs to you or your insurance company beyond usual care.
Benefits
You will be linked to a psychiatrist and case manager as part of your cancer care team 
during cancer treatment. We will give you $25 after completing the first set of questionnaires 
and another $25 after completing the third set of questionnaires in the form of cash or check, to 
thank you for your time. 
Confidentiality 
There is little risk involved with study participation. We will be extremely careful to 
protect your privacy and health information by locking survey material in file cabinets and 
storing data on password protected computers. Only our study team can access this 
information.  Your responses will be kept confidential. You can stop participating in the study 
at any time. If the results of this research study are published in a medical journal, they will not 
identify individual patients. We share your health information only when we must, and we ask 
anyone who receives it from us to protect your privacy. For example, if we are concerned about 
your safety or the safety of others, we may need to discuss this information with your medical 
team. 
 
Participation
Please note that participation in this study is completely voluntary and will not affect 
your medical care at the Massachusetts General Hospital. You can stop participating in the 
research study at any time, and you can still get your medical care from your hospital or 
Investigator. We appreciate your time and consideration. 
Contact Information
If you have questions about the study, please contact:
Research assistant: Catherine Callaway (617-726-2297), M-F  9am-5pm. 
Principal investigator (licensed psychiatrist): Dr. Kelly Irwin Irwin (617-643-4453) 
For questions about your rights as a research participant, please contact a 
representative of the Office for Human Research Studies at DFCI (617) 632-3029. This can 
include questions about your participation in the study, concerns about the study, a research 
related injury, or if you feel/felt under pressure to enroll in this research study or to continue 
to participate in this research study.
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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I. Caregiver Verbal Consent 
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients 
with Cancer
Caregiver Consent
Principal Investigator: Kelly Irwin, MD
Contact information: Call 617-643-4453 
Purpose of the Research
It is challenging to cope with cancer.  We are conducting a study to understand if having 
a psychiatrist and case manager as part of the cancer care team at the time of cancer diagnosis 
might improve patients’ cancer care. Many people with illnesses like major depression, 
schizophrenia and bipolar disorder face barriers to receiving high quality cancer care. It can be 
difficult to get to appointments, have many different doctors, and experience depression or 
worry. Better communication between the patient, caregivers, the oncology team, and mental 
health providers may improve care. As for all patients, it is important for people with mental 
illness to have access to high quality cancer treatment that is patient-centered and coordinated.  
We want to understand if is helpful for patients with mental illness to be connected to a case 
manager and psychiatrist at the cancer center. 
Study Information
We are asking you to participate in this study because you are a caregiver for an 
individual who may benefit from this intervention. During the study, the patient will be 
connected to a psychiatrist and case manager who will be a part of their cancer care team. They 
will be available to him/her and communicate with the oncology team throughout cancer 
treatment.  A case manager will help identify the patient’s needs, find resources, and 
communicate with the people who support him/her. 
You will complete a brief set of questionnaires by phone, email, or in-person, whichever 
is least burdensome, which will take about 30-45 minutes. In 6 weeks, we will ask you to 
complete a second set of questionnaires, which will take about 10 minutes. In three months, we 
will ask you to complete a third set of questionnaires with study staff, which will take about 20 
minutes. 
Potential Risks and Discomforts
This study does not have any physical risks. You will not be injured or become 
physically sick because of participating in this study. Some of the items on the questionnaire 
may be upsetting. If any of the questions upset you, you can talk to members of the study team. 
The research assistant and study clinician will be available to you, and you can also meet with 
our case manager or the principal investigator, a licensed psychiatrist, for additional support 
who can refer you to additional services as needed. If your responses indicate that you are in 
severe distress, a study clinician will call you to follow-up and assess your safety. At that point, 
you may be offered a referral to appropriate services, which you may accept or decline. Your 
healthcare team may be notified of this referral. 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Your responses to the questionnaires will be written down on paper or completed 
online. Your identity will be kept confidential and we will be extremely careful to protect your 
privacy. That data will be used only by study staff and will be protected by a password.
Benefits
We hope that participation will help us to understand the needs of caregivers for 
patients with cancer and mental illness and help us to support patients coping with these 
challenges and the network of people who support them. We will give you $25 after completing 
the first set of questionnaires and another $25 after completing the third set of questionnaires 
in the form of cash or check, to thank you for your time.
Confidentiality 
There is little risk involved with study participation. We will be extremely careful to 
protect your privacy by locking survey material in file cabinets and storing data on password 
protected computers. Only our study team can access this information.  Your responses will be 
kept confidential. If the results of this research study are published in a medical journal, they 
will not identify individuals. 
 
Participation
Please note that participation in this study is completely voluntary. You can stop 
participating in the research study at any time, and leaving the research study will not affect 
your loved one’s medical care. You can still get your medical care from your hospital or 
Investigator. We appreciate your time and consideration. 
Contact Information
If you have questions about the study, please contact:
Research assistant: Catherine Callaway (617-726-2297), M-F  9am-5pm. 
Principal investigator (licensed psychiatrist): Dr. Kelly Irwin Irwin (617-643-4453) 
 
For questions about your rights as a research participant, please contact a 
representative of the Office for Human Research Studies at DFCI (617) 632-3029. This can 
include questions about your participation in the study, concerns about the study, a research 
related injury, or if you feel/felt under pressure to enroll in this research study or to continue 
to participate in this research study. 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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J. Assessment of Capacity to Participate in Clinical Research 
Proactive Psychiatry Consultation for Patients with Cancer
Proposed questions to assess capacity to participate in clinical research:
1)
Do you want to participate in this research study?
2)
What is the study about?
3)
What benefits do you get from participating in this study?
4)
Why do you want to participate?
In his/her answers to the above questions, the research subject has indicated that

He/she communicates the choice to participate in the proposed research study.
Participation is his/her choice.
The participation is voluntary.

He/she has a factual understanding of the research study.
Aims
Institutional affiliations of the researcher
Methods 
  
Anticipated benefits
Sources of Funding
Potential Risks
Possible conflicts of interest
Discomfort it may entail 

He/she has an appreciation of the significance of the facts about research participation.
This is a research study, not treatment.
There might be no immediate benefit.

He/she is able to reason about research participation.
Cognitive limitations considered.
Limitations due to psychosis considered.
Limitations due to affective state considered.
SUMMARY STATEMENT 

Informed consent obtained.

Subject has capacity to provide informed consent to participate in research despite the 
following (potentially limiting) factors:
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
____________________________________
__________________
Signature
Date
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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K. Patient Baseline Questionnaires
PATIENT ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: Baseline
 
 Patient-Reported Measures
Date
1
BACKGROUND INFORMATION
 
2
PSYCH RESOURCE UTILIZATION QUESTIONNAIRE
 
3
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
4
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
5
PATIENT ACTIVATION MEASURE (PAM)
 
6
THE M.D. ANDERSON SYMPTOM INVENTORY (MDASI)
 
7
DISCRIMINATION IS MEDICAL SETTINGS SCALE (DMS)
8
TRUST IN PHYSICIAN SCALE (TPS)
9
HEALTH LEADS SOCIAL NEED SCREENING TOOLKIT
10
PARTICIPANT LOCATOR FORM
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Demographics
Please check the appropriate box or boxes.
1. Gender
Man 
Woman
Other
2. Ethnicity
Hispanic or Latino
Not Hispanic or Latino
3. Race (please check all that apply)
American Indian or Alaskan native
Asian
African American or Black
Native Hawaiian or other Pacific Islander
White
Other (please specify) _____________
4. Religion
Catholic Christian
Other Christian (such as Protestant, 
Orthodox, etc.)
Jewish
Muslim
Atheist
None
Other (please specify)_______________
5. Current relationship status
Married or living with someone as if married
Non-cohabiting relationship
Single, never married
Divorced/Separated
Loss of long term partner/ Widowed
6. Please indicate your highest or current 
education level
11th grade or less
High school graduate or GED
2 years of college/AA degree/Technical    
school training
College graduate (BA or BS)
Masters degree
Doctorate/Medical degree/Law degree
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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7. What is your annual combined household 
income?
Less than $25,000
$25,000 – 50,000
$50,000 -100,000
$100,000 – 150,000
Greater than $150,000
8. Please indicate who you live with (you may 
check more than one box)
By myself
Partner/Spouse
Roommate/Friend
Children under 18
Children over 18
Group home/assisted living/nursing home
Parent
Other (please specify) _____________
9. Current employment status
(please check all that apply): 
Employed (full-time or part-time)
Caring for home or family (not currently 
working and not looking for paid work)
Unemployed and looking for work
Unable to work due to illness or disability
Retired
Student
Other (please specify) _____________
10.  Aside from mental health professionals, is there 
a medical health professional you see most often (a 
primary care provider)?
Yes
No
11. If yes, who is your primary care provider?
________________________________
12.  When was your last visit to your primary care 
provider?
______________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Resource Utilization Questionnaire
1. Are you currently receiving any of the following mental health services at MGH? Please 
check all that apply: 

No services at this time

Support Group

Social Worker

Psychologist

Psychiatrist

Other:___________________
2. Are you currently receiving any of the following mental health services outside of MGH? 
Please check all that apply:

No services at this time

Support Group

Social Worker

Psychologist

Psychiatrist

Case manager

Day program

Visiting nurse (VNA)

Department of Mental Health (DMH) Services

Other:___________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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3. Have you ever been hospitalized for mental illness (such as depression, anxiety, bipolar 
disorder, or schizophrenia)?

Yes

No
3a. If yes, have you been hospitalized more than once?

Yes

No
3b. When was your last hospitalization ___________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, 
IN THE PAST WEEK? Please read each item and circle one number in each row to 
indicate your answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a 
lot more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Patient Activation Measure (PAM)
1. When all is said and done, I am the person who is 
responsible for managing my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in my own health care is the 
most important factor in determining my health and 
ability to function
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I am confident that I can take actions that will help 
prevent or minimize some symptoms or problems 
associated with my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I know what each of my prescribed medications do
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident that I can tell when I need to go get 
medical care and when I can handle a health problem 
myself
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident I can tell my health care provider 
concerns I have even when he or she does not ask
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I am confident that I can follow through on medical 
treatments I need to do at home
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I understand the nature and causes of my health 
condition(s)
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I know the different medical treatment options 
available for my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I have been able to maintain the lifestyle changes for 
my health that I have made
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
11. I know how to prevent further problems with my 
health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
12. I am confident I can figure out solutions when new 
situations or problems arise with my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
13. I am confident that I can maintain lifestyle changes 
like diet and exercise even during times of stress
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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MDASI
Part I. How severe are your symptoms?
People with cancer frequently have symptoms that are caused by their disease or by their treatment. 
We ask you to rate how severe the following symptoms have been in the last 24 hours. Please fill in 
the circle below from 0 (symptom has not been present) to 10 (the symptoms was as bad as you can 
imagine it could be) for each item.
Not 
Present
As Bad As You 
Can Imagine
0
1
2
3
4
5
6
7
8
9
10
1. Your pain at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
2. Your fatigue (tiredness) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
3. Your nausea at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
4. Your disturbed sleep at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
5. Your feelings of being distressed 
(upset) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
6. Your shortness of breath at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
7. Your problem with remembering 
things at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
8. You problem with lack of appetite at 
its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
9. Your feeling drowsy (sleepy) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
10.Your having a dry mouth at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
11.Your feeling sad at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
12.Your vomiting at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
13.Your numbness or tingling at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Part II. How have your symptoms interfered with your life?
Symptoms frequently interfere with how we feel and function. How much have your symptoms 
interfered with the following items in the last 24 hours:
Did Not 
Interfere
Interfered 
Completely
0
1
2
3
4
5
6
7
8
9
10
14.General activity?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
15.Mood?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
16.Work (including work around the 
house)?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
17.Relations with other people?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
18.Walking?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
19.Enjoyment of life?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Discrimination in Medical Settings Scale
In your prior experiences receiving health care, how often did the following experiences happen 
to you?
Never
Rarely
Sometime
s
Most of 
the time
Always
1
You are treated with less courtesy 
than other people.
1
2
3
4
5
2
You are treated with less respect 
than other people.
1
2
3
4
5
3
You receive poorer service than 
others.
1
2
3
4
5
4
A doctor or nurse acts as if he or 
she thinks you are not smart.
1
2
3
4
5
5
A doctor or nurse acts as if he or 
she is afraid of you.
1
2
3
4
5
6
A doctor or nurse acts as if he or 
she is better than you.
1
2
3
4
5
7
You feel like a doctor or nurse is 
not listening to what you were 
saying.
1
2
3
4
5
Follow-up Question (Asked only of those answering “Sometimes” or more frequently to at least 
one question.): What do you think is the main reason for these experiences? (CHECK MORE 
THAN ONE IF VOLUNTEERED). 
 
RECOMMENDED OPTIONS 
1. Your Ancestry or National Origins 
2. Your Gender  
3. Your Race 
4. Your Age 
5. Your Mental Illness
6. Your Religion 
7. Your Weight 
8. Some other Aspect of Your Physical Appearance 
9. Your Sexual Orientation 
10. Your Education or Income Level
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Trust in Physician Scale (TPS)
1. I doubt that my doctor really cares 
about me as a person
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
2. My doctor is usually considerate of my 
needs and puts them first
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
3. I trust my doctor so much that I always 
try to follow his/her advice
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
4. If my doctor tells me something is so, 
then it must be true
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
5. I sometimes distrust my doctor’s 
opinion and would like a second one
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
6. I trust my doctor’s judgment about my 
medical care
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
7. I feel my doctor does not do everything 
he/she should for my medical care
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
8. I trust my doctor to put my medical 
needs above all other considerations 
when treating my medical problems
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
9. My doctor is a real expert in taking care 
of medical problems like mine
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
10. I trust my doctor to tell me if a mistake 
was made about my treatment
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
11. I sometimes worry that my doctor may 
not keep the information we discuss 
totally private
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Health Leads Social Need Screening Toolkit
Preferred Language:
Best time to call:
Yes
No
1. In the last 12 months, did you ever eat less than you felt you should 
because there wasn’t enough money or food?
2. In the last 12 months, has your utility company shut off your service 
for not paying your bills?
3. Are you worried that in the next 2 months, you may not have stable 
housing?
4. Do problems getting child care make it difficult for you to work or 
study? 
(leave blank if you do not have children)
5. In the last 12 months, have you needed to see a doctor, but could not 
because of cost?
6. In the last 12 months, have you ever had to go without health care 
because you didn’t have a way to get there?
7. Do you ever need help reading hospital materials?
8. Are you afraid you might be hurt in your apartment building or 
house?
9. If you checked YES to any boxes above, would you like to receive 
assistance with any of these needs?
10. Are any of your needs urgent?
For example: I don’t have food tonight, I don’t have a place to sleep 
tonight
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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PARTICIPANT LOCATOR FORM
Participant name: 
__________________________________________________
Home address: 
__________________________________________________
  
(Street)
    
(Apt.)
__________________________________________________
  
(City, State, Zip)
    
Preferred phone: 
__________________________________________________
Alternate phone: 
__________________________________________________
Email: (will only be used if necessary): 
IN CASE WE HAVE TROUBLE REACHING YOU, PLEASE PROVIDE ONE OTHER PERSON 
WE COULD CONTACT (This is optional and will not affect your participation in the research 
study).
Contact name: 
__________________________________________________
(Last)
    
 
(First)     
 (M.I.)
Relationship to participant: 
__________________________________________________
Preferred phone: 
__________________________________________________
Alternate phone: 
__________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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L. Patient Interval Questionnaire
PATIENT ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 6 Weeks
 
Patient-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
DISCRIMINATION IN MEDICAL SETTINGS SCALE (DMS)
4
PATIENT ACTIVATION MEASURE (PAM)
 
5
THE M.D. ANDERSON SYMPTOM INVENTORY (MDASI)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, 
IN THE PAST WEEK? Please read each item and circle one number in each row to 
indicate your answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a 
lot more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Discrimination in Medical Settings Scale
In your prior experiences receiving health care, how often did the following experiences happen 
to you?
Never
Rarely
Sometimes
Most of 
the time
Always
1
You are treated with less courtesy 
than other people.
1
2
3
4
5
2
You are treated with less respect 
than other people.
1
2
3
4
5
3
You receive poorer service than 
others.
1
2
3
4
5
4
A doctor or nurse acts as if he or she 
thinks you are not smart.
1
2
3
4
5
5
A doctor or nurse acts as if he or she 
is afraid of you.
1
2
3
4
5
6
A doctor or nurse acts as if he or she 
is better than you.
1
2
3
4
5
7
You feel like a doctor or nurse is not 
listening to what you were saying.
1
2
3
4
5
Follow-up Question (Asked only of those answering “Sometimes” or more frequently to at least 
one question.): What do you think is the main reason for these experiences? (CHECK MORE 
THAN ONE IF VOLUNTEERED). 
 
RECOMMENDED OPTIONS 
1. Your Ancestry or National Origins 
2. Your Gender  
3. Your Race 
4. Your Age 
5. Your Mental Illness
6. Your Religion 
7. Your Weight 
8. Some other Aspect of Your Physical Appearance 
9. Your Sexual Orientation 
10. Your Education or Income Level
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Patient Activation Measure (PAM)
1. When all is said and done, I am the person who is 
responsible for managing my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in my own health care is the 
most important factor in determining my health and 
ability to function
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I am confident that I can take actions that will help 
prevent or minimize some symptoms or problems 
associated with my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I know what each of my prescribed medications do
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident that I can tell when I need to go get 
medical care and when I can handle a health problem 
myself
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident I can tell my health care provider 
concerns I have even when he or she does not ask
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I am confident that I can follow through on medical 
treatments I need to do at home
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I understand the nature and causes of my health 
condition(s)
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I know the different medical treatment options 
available for my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I have been able to maintain the lifestyle changes 
for my health that I have made
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
11. I know how to prevent further problems with my 
health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
12. I am confident I can figure out solutions when new 
situations or problems arise with my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
13. I am confident that I can maintain lifestyle changes 
like diet and exercise even during times of stress
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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MDASI
Part I. How severe are your symptoms?
People with cancer frequently have symptoms that are caused by their disease or by their treatment. 
We ask you to rate how severe the following symptoms have been in the last 24 hours. Please fill in 
the circle below from 0 (symptom has not been present) to 10 (the symptoms was as bad as you can 
imagine it could be) for each item.
Not 
Present
As Bad As You 
Can Imagine
0
1
2
3
4
5
6
7
8
9
10
20. Your pain at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
21. Your fatigue (tiredness) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
22. Your nausea at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
23. Your disturbed sleep at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
24. Your feelings of being distressed 
(upset) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
25. Your shortness of breath at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
26. Your problem with remembering 
things at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
27. You problem with lack of appetite at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
28. Your feeling drowsy (sleepy) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
29. Your having a dry mouth at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
30. Your feeling sad at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
31. Your vomiting at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
32. Your numbness or tingling at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
Part II. How have your symptoms interfered with your life?
Symptoms frequently interfere with how we feel and function. How much have your 
symptoms interfered with the following items in the last 24 hours:
Did Not 
Interfere
Interfered 
Completely
0
1
2
3
4
5
6
7
8
9
10
33. General activity?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
34. Mood?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
35. Work (including work around the 
house)?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
36. Relations with other people?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
37. Walking?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
38. Enjoyment of life?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
M. Patient 12 Week Questionnaire and Exit Feedback
PATIENT ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 12 Weeks
 
Patient-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-
TREATMENT SATISFACTION-PATIENT SATISFACTION (FACIT-TS-PS)
 
4
DISCRIMINATION IN MEDICAL SETTINGS SCALE (DMS)
5
PATIENT ACTIVATION MEASURE (PAM)
 
6
THE M.D. ANDERSON SYMPTOM INVENTORY (MDASI)
7
TRUST IN PHYSICIAN SCALE (TPS)
8
PSYCH RESOURCE UTILIZATION QUESTIONNAIRE
9
PARTICIPANT FEEDBACK
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, 
IN THE PAST WEEK? Please read each item and circle one number in each row to 
indicate your answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a 
lot more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
FACIT-TS-PS (Version 4)
These questions are about the quality of the health care services you are currently receiving. All 
of your responses will be kept confidential. Please mark one answer for each of the following 
questions.
Physician Communication
No, not at 
all
Yes, but 
not as 
much as I 
wanted
Yes, 
almost as 
much as I 
wanted
Yes, and 
as much 
as I 
wanted
TS9
Did your doctor(s) give explanations that you 
could understand?
.....................................................................................
0
1
2
3
TS10
Did your doctor(s) explain the possible benefits of 
your treatment?
.....................................................................................
0
1
2
3
TS11
Did your doctor(s) explain the possible side effects 
or risks of your treatment?
.....................................................................................
0
1
2
3
TS12
Did you have an opportunity to ask questions?
.....................................................................................
0
1
2
3
TS13
Did you get to say the things that were important 
to you?
....................................................................................
0
1
2
3
TS14
Did your doctor(s) seem to understand what was 
important to you?
....................................................................................
0
1
2
3
TS15
Did your doctor(s) show genuine concern for you?
....................................................................................
0
1
2
3
TS16
Did your doctor(s) seem to understand your needs?
....................................................................................
0
1
2
3
TS18
Were you able to talk to your doctor(s) when you 
needed to?
....................................................................................
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
TS27
Were you encouraged to participate in decisions 
about your health care?
....................................................................................
0
1
2
3
TS28
Did you have enough time to make decisions about 
your health care?
....................................................................................
0
1
2
3
TS30
Did your doctor(s) seem to respect your opinions?
....................................................................................
0
1
2
3
Confidence and Trust
No, not 
at all
Yes, but 
not as 
much as 
I wanted
Yes, 
almost as 
much as 
I wanted
Yes, and as 
much as I 
wanted
TS34
Did you feel that the treatment staff answered your 
questions honestly?
....................................................................................
0
1
2
3
TS35
Did the treatment staff respect your privacy?
....................................................................................
0
1
2
3
TS36
Did you have confidence in your doctor(s)?
....................................................................................
0
1
2
3
TS37
Did you trust your doctor(s)' suggestions for 
treatment?
0
1
2
3
Overall
No
Maybe
Yes
TS38
Would you recommend this clinic or office to 
others?
..............................................................................
0
1
2
TS39
Would you choose this clinic or office again?
..............................................................................
0
1
2
Poor
Fair
Good
Very 
Good
Excellent
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
TS40
How do you rate the care you received?
...............................................................................
0
1
2
3
4
Thank you! Do you have any comments? 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
Discrimination in Medical Settings Scale
In your prior experiences receiving health care, how often did the following experiences happen 
to you?
Never
Rarely
Sometimes
Most of 
the time
Always
1
You are treated with less courtesy 
than other people.
1
2
3
4
5
2
You are treated with less respect 
than other people.
1
2
3
4
5
3
You receive poorer service than 
others.
1
2
3
4
5
4
A doctor or nurse acts as if he or she 
thinks you are not smart.
1
2
3
4
5
5
A doctor or nurse acts as if he or she 
is afraid of you.
1
2
3
4
5
6
A doctor or nurse acts as if he or she 
is better than you.
1
2
3
4
5
7
You feel like a doctor or nurse is not 
listening to what you were saying.
1
2
3
4
5
Follow-up Question (Asked only of those answering “Sometimes” or more frequently to at least 
one question.): What do you think is the main reason for these experiences? (CHECK MORE 
THAN ONE IF VOLUNTEERED). 
 
RECOMMENDED OPTIONS 
1. Your Ancestry or National Origins 
2. Your Gender  
3. Your Race 
4. Your Age 
5. Your Mental Illness
6. Your Religion 
7. Your Weight 
8. Some other Aspect of Your Physical Appearance 
9. Your Sexual Orientation 
10. Your Education or Income Level
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Patient Activation Measure (PAM)
1. When all is said and done, I am the person who is 
responsible for managing my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in my own health care is the 
most important factor in determining my health and 
ability to function
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I am confident that I can take actions that will help 
prevent or minimize some symptoms or problems 
associated with my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I know what each of my prescribed medications do
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident that I can tell when I need to go get 
medical care and when I can handle a health problem 
myself
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident I can tell my health care provider 
concerns I have even when he or she does not ask
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I am confident that I can follow through on medical 
treatments I need to do at home
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I understand the nature and causes of my health 
condition(s)
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I know the different medical treatment options 
available for my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I have been able to maintain the lifestyle changes 
for my health that I have made
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
11. I know how to prevent further problems with my 
health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
12. I am confident I can figure out solutions when new 
situations or problems arise with my health condition
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
13. I am confident that I can maintain lifestyle changes 
like diet and exercise even during times of stress
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
M.D. Anderson Symptom Inventory
Part I. How severe are your symptoms?
People with cancer frequently have symptoms that are caused by their disease or by their treatment. 
We ask you to rate how severe the following symptoms have been in the last 24 hours. Please fill in 
the circle below from 0 (symptom has not been present) to 10 (the symptoms was as bad as you can 
imagine it could be) for each item.
Not 
Present
As Bad As You 
Can Imagine
0
1
2
3
4
5
6
7
8
9
10
39. Your pain at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
40. Your fatigue (tiredness) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
41. Your nausea at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
42. Your disturbed sleep at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
43. Your feelings of being distressed 
(upset) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
44. Your shortness of breath at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
45. Your problem with remembering 
things at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
46. You problem with lack of appetite at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
47. Your feeling drowsy (sleepy) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
48. Your having a dry mouth at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
49. Your feeling sad at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
50. Your vomiting at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
51. Your numbness or tingling at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Part II. How have your symptoms interfered with your life?
Symptoms frequently interfere with how we feel and function. How much have your 
symptoms interfered with the following items in the last 24 hours:
Did Not 
Interfere
Interfered 
Completely
0
1
2
3
4
5
6
7
8
9
10
52. General activity?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
53. Mood?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
54. Work (including work around the 
house)?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
55. Relations with other people?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
56. Walking?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
57. Enjoyment of life?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Trust in Physician Scale (TPS)
1. I doubt that my doctor really cares about 
me as a person
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
2. My doctor is usually considerate of my 
needs and puts them first
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
3. I trust my doctor so much that I always try 
to follow his/her advice
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
4. If my doctor tells me something is so, then 
it must be true
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
5. I sometimes distrust my doctor’s opinion 
and would like a second one
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
6. I trust my doctor’s judgment about my 
medical care
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
7. I feel my doctor does not do everything 
he/she should for my medical care
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
8. I trust my doctor to put my medical needs 
above all other considerations when treating 
my medical problems
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
9. My doctor is a real expert in taking care of 
medical problems like mine
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
10. I trust my doctor to tell me if a mistake 
was made about my treatment
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
11. I sometimes worry that my doctor may not 
keep the information we discuss totally 
private
Disagree       Disagree     Agree       Agree         
N/A
Strongly                                           Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Resource Utilization Questionnaire
Please answer the following questions if you have a psychiatrist, social worker, case manager, or 
therapist that you saw before your diagnosis of cancer.
1. How many times have you seen your psychiatrist since you learned of your cancer 
diagnosis?

I did not have a psychiatrist before my cancer diagnosis

Not at all

Once

2-5 times

More than 5 times
2. How many times have you seen or talked with your therapist or social worker since 
you learned of your cancer diagnosis?

I did not have a therapist or social worker before my cancer diagnosis

Not at all

Once

2-5 times

More than 5 times
3. How many times have you seen or talked with your case manager since you learned 
of your cancer diagnosis?

I did not have a case manager before my cancer diagnosis.

Not at all

Once

2-5 times

More than 5 times
4. Have you been hospitalized for your mental illness (such as depression, anxiety, 
bipolar disorder, or schizophrenia) since you learned of your cancer diagnosis?

Yes

No
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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PATIENT -12-WEEK PARTICIPANT FEEDBACK
We are now interested to know about your satisfaction with different aspects of this intervention.  There is 
no right or wrong answer. Your answers will be kept confidential and will not affect your participation in 
future research studies, or your access to care at MGH or affiliated sites. As a reminder, you 
participated in a research study of an intervention that involved a psychiatrist (Dr. Irwin or Dr. 
Hirschberg) and a social work case manager (Amy Corveleyn) in your cancer care team.
1.
From your perspective, how useful was the intervention in your cancer care?   
Very useful                Somewhat useful                A little bit useful                    Not at all useful
2.  How useful were the following parts of the intervention? 
3. What did you think was the most useful part about the intervention?
____________________________________________________________________________________
____________________________________________________________________________________
4. What do you feel could be improved about the intervention?  
____________________________________________________________________________________
____________________________________________________________________________________
5. What else, if anything, would you like to add about the intervention that we did not discuss? 
____________
Thank you for being a part of the Proactive Psychiatry Consultation for Patients with Cancer Study. Your 
feedback is valuable to us and we appreciate your responses.
Involving psychiatry early in your cancer care 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful 
Don’t know/ Does 
not apply to me
Meeting with your psychiatrist, (Dr. Irwin/Dr. 
Hirschberg) in person
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Being able to reach your psychiatrist (Dr. Irwin/Dr. 
Hirschberg) by phone or email
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Being able to reach your case manager, Amy, by 
phone or email
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Communicating with your community mental health 
clinicians 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Meeting with your cancer and psychiatry teams 
together
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Helping with barriers to your care (e.g. rides to the 
hospital, insurance, housing)
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Addressing your psychiatric symptoms and 
medications 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Involving your caregiver in your cancer care 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
N. Caregiver Baseline Questionnaire
Date: _________
Study ID: ______
Time point: Baseline
 
 Caregiver-Reported Measures
Date
1
BACKGROUND INFORMATION
 
2
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
3
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
4
CAREGIVER PATIENT ACTIVATION MEASURE (CG-PAM)
 
5
CAREGIVER REACTION ASSESSMENT
 
6
DISCRIMINATION IN MEDICAL SETTINGS SCALE (DMS)
7
PEARLIN MASTERY SCALE
8
PARTICIPANT LOCATOR FORM
 
CAREGIVER ASSESSMENT CHECKLIST
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Demographics
Please check the appropriate box or boxes.
10. Gender
Man 
Woman
Other
11. Ethnicity
Hispanic or Latino
Not Hispanic or Latino
12. Race (please check all that apply)
American Indian or Alaskan native
Asian
African American or Black
Native Hawaiian or other Pacific Islander
White
Other (please specify) _____________
13. Religion
Catholic Christian
Other Christian (such as Protestant, 
Orthodox, etc.)
Jewish
Muslim
Atheist
None
Other (please specify)_______________
14. Current relationship status
Married or living with someone as if 
married
Non-cohabiting relationship
Single, never married
Divorced/Separated
Loss of long term partner/ Widowed
15. Please indicate your highest or current 
education level
11th grade or less
High school graduate or GED
2 years of college/AA degree/Technical    
school training
College graduate (BA or BS)
Masters degree
Doctorate/Medical degree/Law degree
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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16. What is your annual combined household 
income?
Less than $25,000
$25,000 – 50,000
$50,000 -100,000
$100,000 – 150,000
Greater than $150,000
17. Please indicate who you live with (you may 
check more than one box)
By myself
Partner/Spouse
Roommate/Friend
Children under 18
Children over 18
Group home/assisted living/nursing home
Parent
Other (please specify) _____________
18. Current employment status
(please check all that apply): 
Employed (full-time or part-time)
Caring for home or family (not currently 
working and not looking for paid work)
Unemployed and looking for work
Unable to work due to illness or disability
Retired
Student
Other (please specify) _____________
10.  Aside from mental health professionals, is 
there a medical health professional you see 
most often (a primary care provider)?
Yes
No
11. If yes, who is your primary care provider?
________________________________
12.  When was your last visit to your primary 
care provider?
_____________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, IN THE 
PAST WEEK? Please read each item and circle one number in each row to indicate your 
answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every day
1.
Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a lot 
more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Caregiver Activation Measure (CG-PAM)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Caregiver Reaction Assessment
Circle the number corresponding to your answer
Questions:
Strongly 
disagree
Disagree
Neither 
agree nor 
disagree
Agree
Strongly 
agree
1.   I feel privileged to care for ___.
1
2
3
4
5
2.  Others have dumped caring for ___ onto me.
1
2
3
4
5
3.  My financial resources are adequate to pay for things
that are required for caregiving.
1
2
3
4
5
4.  My activities are centered around care for ___.
1
2
3
4
5
5.  Since caring for ___, it seems like I’m tired all of the
time. 
1
2
3
4
5
6.  It is very difficult to get help from my family in 
taking care of ___.
1
2
3
4
5
7.   I resent having to take care of ___.
1
2
3
4
5
8.   I have to stop in the middle of work.
1
2
3
4
5
9.   I really want to care for ___.
1
2
3
4
5
10. My health has gotten worse since I’ve been caring 
for ___.
1
2
3
4
5
11. I visit family and friends less since I have been 
caring for ___.
1
2
3
4
5
12.  I will never be able to do enough caregiving to 
repay ___.
1
2
3
4
5
13. My family works together at caring for ___.
1
2
3
4
5
14. I have eliminated things from my schedule since 
caring for ___.
1
2
3
4
5
15. I have enough physical strength to care for ___.
1
2
3
4
5
16. Since caring for ___, I feel my family has 
abandoned me.
1
2
3
4
5
17. Caring for ___ makes me feel good.
1
2
3
4
5
18. The constant interruptions make it difficult to find 
time for relaxation.
1
2
3
4
5
19. I am healthy enough to care for ___.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
20. Caring for ___ is important to me.
1
2
3
4
5
21. Caring for ___ has put a financial strain on the 
family.
1
2
3
4
5
22. My family (brothers, sisters, children) left me alone 
to care for ___.
1
2
3
4
5
23. I enjoy caring for ___.
1
2
3
4
5
24. It's difficult to pay for ___'s health needs and 
services.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Discrimination in Medical Settings Scale
In your experience as a caregiver for this patient, how often have you witnessed the patient 
experience the following in the his/her health care?
Never
Rarely
Sometimes
Most of 
the time
Always
1
You are treated with less courtesy 
than other people.
1
2
3
4
5
2
You are treated with less respect 
than other people.
1
2
3
4
5
3
You receive poorer service than 
others.
1
2
3
4
5
4
A doctor or nurse acts as if he or she 
thinks you are not smart.
1
2
3
4
5
5
A doctor or nurse acts as if he or she 
is afraid of you.
1
2
3
4
5
6
A doctor or nurse acts as if he or she 
is better than you.
1
2
3
4
5
7
You feel like a doctor or nurse is not 
listening to what you were saying.
1
2
3
4
5
 
Follow-up Question (Asked only of those answering “Sometimes” or more frequently to at least 
one question.): What do you think is the main reason for the patient’s experiences? (CHECK 
MORE THAN ONE IF VOLUNTEERED). 
 
RECOMMENDED OPTIONS 
1. Ancestry or National Origins 
2. Gender  
3. Race 
4. Age 
5. Mental Illness
6. Religion 
7. Weight 
8. Some other Aspect of Physical Appearance 
9. Sexual Orientation 
10. Education or Income Level
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Pearlin Mastery Scale
1. There is really no way I can solve some of 
the problems that I have
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
2. Sometimes I feel that I’m being pushed 
around in life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
3. I have little control over the things that 
happen to me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
4. I can do just about anything I really set my 
mind to
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
5. I often feel helpless in dealing with the 
problems of life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
6. What happens to me in the future mostly 
depends on me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
7. There is little I can do to change many of 
the important things in my life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
PARTICIPANT LOCATOR FORM
Participant name: 
__________________________________________________
Home address: 
__________________________________________________
  
(Street)
    
(Apt.)
__________________________________________________
  
(City, State, Zip)
    
Preferred phone: 
__________________________________________________
Alternate phone: 
__________________________________________________
Email: (will only be used if necessary): 
IN CASE WE HAVE TROUBLE REACHING YOU, PLEASE PROVIDE ONE OTHER PERSON 
WE COULD CONTACT (This is optional and will not affect your participation in the research 
study).
Contact name: 
__________________________________________________
(Last)
    
 
(First)     
 (M.I.)
Relationship to participant: 
__________________________________________________
Preferred phone: 
__________________________________________________
Alternate phone: 
__________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
O. Caregiver Interval Questionnaire
CAREGIVER ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 6 Weeks
 
Caregiver-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
DISCRIMINATION IN MEDICAL SETTINGS SCALE (DMS)
4
CAREGIVER PATIENT ACTIVATION MEASURE (CG-PAM)
 
5
CAREGIVER REACTION ASSESSMENT
6
PEARLIN MASTERY SCALE
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, IN THE 
PAST WEEK? Please read each item and circle one number in each row to indicate your 
answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every day
1.
Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a lot 
more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Discrimination in Medical Settings Scale
In your experience as a caregiver for this patient, how often have you witnessed the patient experience 
the following in the his/her health care?
Never
Rarely
Sometimes
Most of 
the time
Always
1
You are treated with less courtesy 
than other people.
1
2
3
4
5
2
You are treated with less respect 
than other people.
1
2
3
4
5
3
You receive poorer service than 
others.
1
2
3
4
5
4
A doctor or nurse acts as if he or she 
thinks you are not smart.
1
2
3
4
5
5
A doctor or nurse acts as if he or she 
is afraid of you.
1
2
3
4
5
6
A doctor or nurse acts as if he or she 
is better than you.
1
2
3
4
5
7
You feel like a doctor or nurse is not 
listening to what you were saying.
1
2
3
4
5
Follow-up Question (Asked only of those answering “Sometimes” or more frequently to at least 
one question.): What do you think is the main reason for the patient’s experiences? (CHECK 
MORE THAN ONE IF VOLUNTEERED). 
 
RECOMMENDED OPTIONS 
1. Ancestry or National Origins 
2. Gender  
3. Race 
4. Age 
5. Mental Illness
6. Religion 
7. Weight 
8. Some other Aspect of Physical Appearance 
9. Sexual Orientation 
10. Education or Income Level
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Caregiver Activation Measure (CG-PAM)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Caregiver Reaction Assessment
Circle the number corresponding to your answer
Questions:
Strongly 
disagree
Disagree
Neither 
agree nor 
disagree
Agree
Strongly 
agree
1.   I feel privileged to care for ___.
1
2
3
4
5
2.  Others have dumped caring for ___ onto me.
1
2
3
4
5
3.  My financial resources are adequate to pay for 
things that are required for caregiving.
1
2
3
4
5
4.  My activities are centered around care for ___.
1
2
3
4
5
5.  Since caring for ___, it seems like I’m tired all of the 
time. 
1
2
3
4
5
6.  It is very difficult to get help from my family in 
taking care of ___.
1
2
3
4
5
7.   I resent having to take care of ___.
1
2
3
4
5
8.   I have to stop in the middle of work.
1
2
3
4
5
9.   I really want to care for ___.
1
2
3
4
5
10. My health has gotten worse since I’ve been caring 
for ___.
1
2
3
4
5
11. I visit family and friends less since I have been 
caring for ___.
1
2
3
4
5
12.  I will never be able to do enough caregiving to 
repay ___.
1
2
3
4
5
13. My family works together at caring for ___.
1
2
3
4
5
14. I have eliminated things from my schedule since 
caring for ___.
1
2
3
4
5
15. I have enough physical strength to care for ___.
1
2
3
4
5
16. Since caring for ___, I feel my family has abandoned
me.
1
2
3
4
5
17. Caring for ___ makes me feel good.
1
2
3
4
5
18. The constant interruptions make it difficult to find 
time for relaxation.
1
2
3
4
5
19. I am healthy enough to care for ___.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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20. Caring for ___ is important to me.
1
2
3
4
5
21. Caring for ___ has put a financial strain on the 
family.
1
2
3
4
5
22. My family (brothers, sisters, children) left me alone 
to care for ___.
1
2
3
4
5
23. I enjoy caring for ___.
1
2
3
4
5
24. It's difficult to pay for ___'s health needs and 
services.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Pearlin Mastery Scale
1. There is really no way I can solve some of the 
problems that I have
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
2. Sometimes I feel that I’m being pushed around 
in life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
3. I have little control over the things that happen 
to me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
4. I can do just about anything I really set my 
mind to
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
5. I often feel helpless in dealing with the 
problems of life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
6. What happens to me in the future mostly 
depends on me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
7. There is little I can do to change many of the 
important things in my life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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P. Caregiver 12 Week Questionnaire and Exit Feedback
CAREGIVER ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 12 Weeks
 
Caregiver-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-
TREATMENT SATISFACTION-PATIENT SATISFACTION (FACIT-TS-PS)
 
4
DISCRIMINATION IN MEDICAL SETTINGS SCALE (DMS)
5
CAREGIVER PATIENT ACTIVATION MEASURE (CG-PAM)
 
6
CAREGIVER REACTION ASSESSMENT
7
PEARLIN MASTERY SCALE 
8
PARTICIPANT FEEDBACK
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, IN THE 
PAST WEEK? Please read each item and circle one number in each row to indicate your 
answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every day
1.
Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a lot 
more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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FACIT-TS-PS (Version 4)
These questions are about the quality of the health care services you are currently receiving. All of your 
responses will be kept confidential. Please mark one answer for each of the following questions.
Physician Communication
No, not at 
all
Yes, but 
not as 
much as I 
wanted
Yes, 
almost as 
much as I 
wanted
Yes, and 
as much 
as I 
wanted
TS9
Did your doctor(s) give explanations that you could 
understand?
..........................................................................................
0
1
2
3
TS10
Did your doctor(s) explain the possible benefits of your 
treatment?
..........................................................................................
0
1
2
3
TS11
Did your doctor(s) explain the possible side effects or 
risks of your treatment?
..........................................................................................
0
1
2
3
TS12
Did you have an opportunity to ask questions?
..........................................................................................
0
1
2
3
TS13
Did you get to say the things that were important to 
you?
...........................................................................................
0
1
2
3
TS14
Did your doctor(s) seem to understand what was 
important to you?
...........................................................................................
0
1
2
3
TS15
Did your doctor(s) show genuine concern for you?
...........................................................................................
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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TS16
Did your doctor(s) seem to understand your needs?
...........................................................................................
0
1
2
3
TS18
Were you able to talk to your doctor(s) when you 
needed to?
...........................................................................................
0
1
2
3
TS27
Were you encouraged to participate in decisions about 
your health care?
...........................................................................................
0
1
2
3
TS28
Did you have enough time to make decisions about 
your health care?
...........................................................................................
0
1
2
3
TS30
Did your doctor(s) seem to respect your opinions?
...........................................................................................
0
1
2
3
Confidence and Trust
No, not 
at all
Yes, but 
not as 
much as I 
wanted
Yes, 
almost as 
much as I 
wanted
Yes, and as 
much as I 
wanted
TS34
Did you feel that the treatment staff answered your 
questions honestly?
...........................................................................................
0
1
2
3
TS35
Did the treatment staff respect your privacy?
...........................................................................................
0
1
2
3
TS36
Did you have confidence in your doctor(s)?
...........................................................................................
0
1
2
3
TS37
Did you trust your doctor(s)' suggestions for 
treatment?
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Overall
No
Maybe
Yes
TS38
Would you recommend this clinic or office to 
others?
.....................................................................................
0
1
2
TS39
Would you choose this clinic or office again?
.....................................................................................
0
1
2
Poor
Fair
Good
Very 
Good
Excellent
TS40
How do you rate the care you received?
....................................................................................
0
1
2
3
4
Thank you! Do you have any comments? 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
____________________________________________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Discrimination in Medical Settings Scale
In your experience as a caregiver for this patient, how often have you witnessed the patient experience 
the following in the his/her health care?
Never
Rarely
Sometimes
Most of 
the time
Always
1
You are treated with less courtesy 
than other people.
1
2
3
4
5
2
You are treated with less respect 
than other people.
1
2
3
4
5
3
You receive poorer service than 
others.
1
2
3
4
5
4
A doctor or nurse acts as if he or she 
thinks you are not smart.
1
2
3
4
5
5
A doctor or nurse acts as if he or she 
is afraid of you.
1
2
3
4
5
6
A doctor or nurse acts as if he or she 
is better than you.
1
2
3
4
5
7
You feel like a doctor or nurse is not 
listening to what you were saying.
1
2
3
4
5
Follow-up Question (Asked only of those answering “Sometimes” or more frequently to at least 
one question.): What do you think is the main reason for the patient’s experiences? (CHECK 
MORE THAN ONE IF VOLUNTEERED). 
 
RECOMMENDED OPTIONS 
1. Ancestry or National Origins 
2. Gender  
3. Race 
4. Age 
5. Mental Illness
6. Religion 
7. Weight 
8. Some other Aspect of Physical Appearance 
9. Sexual Orientation 
10. Education or Income Level
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Caregiver Activation Measure (CG-PAM)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Caregiver Reaction Assessment
Circle the number corresponding to your answer
Questions:
Strongly 
disagree
Disagree
Neither 
agree nor 
disagree
Agree
Strongly 
agree
1.   I feel privileged to care for ___.
1
2
3
4
5
2.  Others have dumped caring for ___ onto me.
1
2
3
4
5
3.  My financial resources are adequate to pay for 
things that are required for caregiving.
1
2
3
4
5
4.  My activities are centered around care for ___.
1
2
3
4
5
5.  Since caring for ___, it seems like I’m tired all of the 
time. 
1
2
3
4
5
6.  It is very difficult to get help from my family in 
taking care of ___.
1
2
3
4
5
7.   I resent having to take care of ___.
1
2
3
4
5
8.   I have to stop in the middle of work.
1
2
3
4
5
9.   I really want to care for ___.
1
2
3
4
5
10. My health has gotten worse since I’ve been caring 
for ___.
1
2
3
4
5
11. I visit family and friends less since I have been 
caring for ___.
1
2
3
4
5
12.  I will never be able to do enough caregiving to 
repay ___.
1
2
3
4
5
13. My family works together at caring for ___.
1
2
3
4
5
14. I have eliminated things from my schedule since 
caring for ___.
1
2
3
4
5
15. I have enough physical strength to care for ___.
1
2
3
4
5
16. Since caring for ___, I feel my family has abandoned
me.
1
2
3
4
5
17. Caring for ___ makes me feel good.
1
2
3
4
5
18. The constant interruptions make it difficult to find 
time for relaxation.
1
2
3
4
5
19. I am healthy enough to care for ___.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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20. Caring for ___ is important to me.
1
2
3
4
5
21. Caring for ___ has put a financial strain on the 
family.
1
2
3
4
5
22. My family (brothers, sisters, children) left me alone 
to care for ___.
1
2
3
4
5
23. I enjoy caring for ___.
1
2
3
4
5
24. It's difficult to pay for ___'s health needs and 
services.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Pearlin Mastery Scale
1. There is really no way I can solve some of the 
problems that I have
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
2. Sometimes I feel that I’m being pushed around 
in life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
3. I have little control over the things that happen 
to me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
4. I can do just about anything I really set my 
mind to
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
5. I often feel helpless in dealing with the 
problems of life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
6. What happens to me in the future mostly 
depends on me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
7. There is little I can do to change many of the 
important things in my life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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CAREGIVER - 12-WEEK PARTICIPANT FEEDBACK
We are now interested to know about your satisfaction with different aspects of this intervention. There 
are no right or wrong answers. Your answers will be kept confidential and will not affect your participation 
in future research studies, or your access to care at MGH or affiliated sites. As a reminder, you 
participated as a caregiver in a research study of an intervention that involved a psychiatrist (Dr. 
Irwin or Dr. Hirschberg) and a social work case manager (Amy Corveleyn) in the patient’s cancer 
care team. 
1.
From your perspective, how useful was the intervention in the patient’s cancer care?   
Very useful                Somewhat useful                A little bit useful                    Not at all useful 
2.    How useful was the intervention for you as a caregiver? 
Very useful                Somewhat useful                A little bit useful                    Not at all useful
3.  How useful were the following parts of the intervention? 
4. What do you think was the most useful part about the intervention in the patient’s cancer care? 
____________________________________________________________________________________
____________________________________________________________________________________
5. What do you think was the most useful part about the intervention for you as a caregiver?
____________________________________________________________________________________
____________________________________________________________________________________
6. What changes, if any, did you notice in your relationship with the patient because of the 
intervention? 
Involving psychiatry early in the patient’s cancer care 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful 
Don’t know/ 
Does not apply 
to me
Meeting with the psychiatrist (Dr. Irwin/Dr. Hirschberg) in 
person
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ 
Does not apply 
to me
Being able to reach the psychiatrist (Dr. Irwin/Dr. 
Hirschberg) by phone or email
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ 
Does not apply 
to me
Being able to reach the case manager, Amy, by phone or 
email
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ 
Does not apply 
to me
Communicating with the patient’s community mental health 
clinicians 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ 
Does not apply 
to me
Meeting with the patient’s cancer and psychiatry teams 
together
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ 
Does not apply 
to me
Helping with barriers to the patient’s care (e.g. rides to the 
hospital, insurance, housing)
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ 
Does not apply 
to me
Addressing the patient’s psychiatric symptoms and 
medications 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ 
Does not apply 
to me
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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____________________________________________________________________________________
____________________________________________________________________________________
7. What do you think could be improved about the intervention? 
____________________________________________________________________________________
____________________________________________________________________________________
8. What else, if anything, would you like to add about the intervention that we did not discuss? 
_____________________________________________
Thank you for being a part of the Proactive Psychiatry Consultation for Patients with Cancer Study. Your 
feedback is valuable to us and we appreciate your responses.
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Q. Clinician Administered Assessments
ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Timepoints: Baseline, 6-week, 12-week
Clinician-Administered Measures
Date
1
BRIEF PSYCHIATRIC RATING SCALE (BPRS)
2
CLINICAL GLOBAL IMPRESSION – SEVERITY (CGI-S)
3
CLINICAL GLOBAL IMPRESSION – IMPROVEMENT (CGI-I)
4
ASSESSMENT OF CAPACITY TO PARTICIPATE
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Baseline Assessments
BRIEF PSYCHIATRIC RATING SCALE (BPRS)
Please enter the score for the term that best describes the patient’s condition
0 = Not assessed, 1 = Not present, 2 = Very mild, 3 = Mild, 4 = Moderate, 5 = 
Moderately severe, 6 = Severe, 7 = Extremely severe 
Score
Condition
1. SOMATIC CONCERN 
2. ANXIETY 
3. DEPRESSION 
4. SUICIDALITY 
5. GUILT 
6. HOSTILITY 
7. ELEVATED MOOD 
8. GRANDIOSITY 
9. SUSPICIOUSNESS 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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10. HALLUCINATIONS 
11. UNUSUAL THOUGHT CONTENT
12. BIZARRE BEHAVIOR
13. SELF-NEGLECT 
14. DISORIENTATION
15. CONCEPTUAL DISORGANIZATION 
16. BLUNTED AFFECT 
17. EMOTIONAL WITHDRAWAL
18. MOTOR RETARDATION
19. TENSION
20. UNCOOPERATIVENESS
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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21. EXCITEMENT
22. DISTRACTABILITY 
23. MOTOR HYPERACTIVITY
24. MANNERISMS AND POSTURING
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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CGI
SEVERITY OF ILLNESS
1. Considering your total clinical experience with this particular population, how 
mentally ill is the patient at this time? 
□ Not Assessed (0)
□ Normal, not at all ill (1)
□ Borderline mentally ill (2)
□ Mildly ill (3)
□ Moderately ill (4)
□ Markedly ill (5)
□ Severely ill (6)
□ Among the most extremely ill patients  (7)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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6-week Interval Assessments 
CGI
SEVERITY OF ILLNESS
1. Considering your total clinical experience with this particular population, how 
mentally ill is the patient at this time? 
□ Not Assessed (0)
□ Normal, not at all ill (1)
□ Borderline mentally ill (2)
□ Mildly ill (3)
□ Moderately ill (4)
□ Markedly ill (5)
□ Severely ill (6)
□ Among the most extremely ill patients  (7)
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CGI
IMPROVEMENT OF ILLNESS
1. Compared to the patient’s condition at admission to the project, this patient’s 
condition is: 
Very much improved since the initiation of treatment (1)
Much improved (2)
Minimally improved (3)
No change from baseline (the initiation of treatment) (4)
Minimally worse (5)
Much worse (6)
Very much worse since the initiation of treatment (7)
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12-week Post Intervention Assessments
BRIEF PSYCHIATRIC RATING SCALE (BPRS)
Please enter the score for the term that best describes the patient’s condition
0 = Not assessed, 1 = Not present, 2 = Very mild, 3 = Mild, 4 = Moderate, 5 = 
Moderately severe, 6 = Severe, 7 = Extremely severe 
Score
Condition
1. SOMATIC CONCERN 
2. ANXIETY 
3. DEPRESSION 
4. SUICIDALITY 
5. GUILT 
6. HOSTILITY 
7. ELEVATED MOOD 
8. GRANDIOSITY 
9. SUSPICIOUSNESS 
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10. HALLUCINATIONS 
11. UNUSUAL THOUGHT CONTENT
12. BIZARRE BEHAVIOR
13. SELF-NEGLECT 
14. DISORIENTATION
15. CONCEPTUAL DISORGANIZATION 
16. BLUNTED AFFECT 
17. EMOTIONAL WITHDRAWAL
18. MOTOR RETARDATION
19. TENSION
20. UNCOOPERATIVENESS
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21. EXCITEMENT
22. DISTRACTABILITY 
23. MOTOR HYPERACTIVITY
24. MANNERISMS AND POSTURING
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CGI
SEVERITY OF ILLNESS
1. Considering your total clinical experience with this particular population, how 
mentally ill is the patient at this time? 
□ Not Assessed (0)
□ Normal, not at all ill (1)
□ Borderline mentally ill (2)
□ Mildly ill (3)
□ Moderately ill (4)
□ Markedly ill (5)
□ Severely ill (6)
□ Among the most extremely ill patients  (7)
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CGI
IMPROVEMENT OF ILLNESS
1. Compared to the patient’s condition at admission to the project, this patient’s 
condition is: 
Very much improved since the initiation of treatment (1)
Much improved (2)
Minimally improved (3)
No change from baseline (the initiation of treatment) (4)
Minimally worse (5)
Much worse (6)
Very much worse since the initiation of treatment (7)
Dana Farber
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R. Oncology and Mental Health Clinician Email Consent
Proactive Psychiatry Consultation and Case Management for Patients with Cancer
Dear [Clinician Name],
I am emailing about your patient [Patient Name], who recently completed participation in Dr. 
Kelly Irwin’s open pilot study of proactive psychiatry consultation and case management for 
patients with serious mental illness. We would love your feedback on how useful the 
intervention has been for [Patient name] and for you, as a clinician.
Can I schedule a 5-10 minute call at a time that is convenient for you? If preferred, you 
can complete the survey via email or in-person.  
Your responses may be used for research purposes.  All data will be kept confidential and 
accessible only to study staff.  Responses will be aggregated and de-identified prior to 
publication. 
Completion of the brief survey will count as your consent to participate in the study.  Please feel 
free to contact the PI, Dr. Kelly Irwin, with any questions or concerns.  
Thank you for your time,
[Study Staff]
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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S. Oncology Clinician Exit Survey 
Proactive Psychiatry Consultation for Patients with Cancer Study 
ONCOLOGY CLINICIANS
We are currently conducting a research study of an intervention involving proactive psychiatry 
consultation and a social work case manager for patients with serious mental illness and a recent 
cancer diagnosis. Your patient, XXXXXX XXXXX, participated in this intervention. We would 
like your feedback on the challenges and benefits of this intervention and how it can be most 
useful to you as an oncology clinician. You will not be compensated for participating in this 
study. 
There are minimal risks involved with providing this feedback. However, it is possible that 
providing feedback may make you feel uncomfortable. The benefits of your participation are that 
researchers may better understand the challenges and benefits of this intervention for patients 
with serious mental illness and cancer. Your participation is voluntary and your responses will be 
kept confidential. We will not collect your name or other identifying information. You can 
withdraw from the study, stop the survey, or choose not to answer any questions. Neither your 
feedback nor your decision to participate will affect your employment or care at Massachusetts 
General Hospital.  If you have questions about the study, you may contact Dr. Kelly Irwin at 
617-643-4453 or kirwin1@partners.org. 
Thank you very much for your time!
1. Please choose what best describes your job. 
Medical Oncologist
Surgical Oncologist
Radiation Oncologist 
Oncologist Nurse Practitioner 
2.   What year did you complete your professional training? ___________
3. Gender: Please choose one answer. 
Male
Female
Other: please specify _________
4. Of the patients you currently care for, how many have cancer and bipolar disorder? 
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Approximate #: _______________
5. Of the patients you currently care for, how many have cancer and schizophrenia? 
Approximate #: _______________
6. Of the patients you currently care for, how many have cancer and severe major depression 
(with prior psychiatric hospitalization or suicide attempt)? 
Approximate #: _______________
The following questions are specifically about your experience caring for your pt XXXX 
who participated in the intervention.
1. How useful was the intervention in the patient’s cancer care? 
Very useful                Somewhat useful                A little bit useful            Not at all useful
What was most useful?
___________________________________________________________________________
___________________________________________________________________________
What would you change to improve the intervention? 
___________________________________________________________________________
___________________________________________________________________________
2. Did this patient receive the same regimen and intensity of cancer treatment as other patients 
who present with the same stage of disease? 
Yes
No
If not, how was the treatment different? 
___________________________________________________________________________
___________________________________________________________________________
3. How much of the cancer treatment that you recommended at the time of cancer diagnosis did 
your patient receive?
100%
Most
Some
A little bit
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None
4. Did this patient have a delay in starting cancer treatment? 
Yes
No
5.   Did this patient have a deviation from guideline-concordant treatment at the time of cancer 
diagnosis? 
Yes
No
6.   Did this patient have an interruption in cancer treatment received?
Yes
No
7. What impact did the intervention have on the cancer care for your patient? 
Large positive 
Small positive
No impact
Small negative
Large negative
impact
     impact
      impact
        impact
7a) Did the intervention impact the cancer treatment plan? 
Yes
No
If yes, how so? 
_________________________________________________________________________
7b) Did the intervention impact your relationship with this patient? 
Yes
No 
If yes, how so? 
__________________________________________________________________________
7c) Did the intervention impact your communication with the patient or caregiver?
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Yes
No 
If yes, how so? 
__________________________________________________________________________
8. Did the intervention help you as the oncologist care for the patient? 
Yes 
No
      If yes, how so? 
__________________________________________________________________________
9. What else, if anything, would you like to add about the intervention that we have not 
discussed?
______________________________________________________________________________
______________________________________________________________________________
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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T. Mental Health Clinician Exit Survey
Proactive Psychiatry Consultation for Patients with Cancer Study 
MENTAL HEALTH CLINICIANS
We are completing a research study of a care delivery model intervention for patients with 
serious mental illness and a recent cancer diagnosis which includes a psychiatry consultation and 
access to a social work case manager. Your patient, XXXXXX XXXXX, participated in this 
study. We would like your feedback on the challenges and benefits of this intervention, and ideas 
on how this intervention can be most useful to you. We estimate that participation will take 5-10 
minutes. You will not be compensated for participating in this study. 
There are minimal risks involved with providing feedback. However, it is possible that providing 
feedback may make you feel uncomfortable. The benefits of your participation are that 
researchers may better understand the challenges and benefits of psychiatry and social work 
interventions for patients with serious mental illness who have been recently diagnosed with 
cancer. Your participation is voluntary and your responses will be kept confidential. We will not 
collect your name or other identifying information about you. You can stop participating, choose 
not to answer any of the questions, or withdraw from the study at any time.  Neither your 
feedback nor your decision to participate will affect your care or your patient’s care at 
Massachusetts General Hospital.  If you have questions about the study, you may contact Dr. 
Kelly Irwin at 617-643-4453 or kirwin1@partners.org. 
Thank you very much for your time!
1. Please select what best describes your clinical discipline: 
 
Licensed Mental Health Clinician
Social Work
Psychology 
Psychiatry
Psychiatric Nurse Practitioner
Other: ____________________
2. What year did you complete your professional training? _________
3. Gender: Please choose one answer. 
Male
Female
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Other: please specify _________
4. Where do you see patients clinically? Please check all that apply. 
A private office
Community mental health clinic 
Academic hospital
Other: ________________
5. Of the patients you currently care for, how many have cancer and bipolar disorder? 
Approximate # ___________
6. Of the patients you currently care for, how many have cancer and schizophrenia? 
Approximate # ___________
7. Of the patients you currently care for, how many have cancer and severe major depression 
(with prior psychiatric hospitalization or suicide attempt)? 
Approximate # ___________
The following questions are specifically about your experience caring for your pt XXXX, 
who participated in the 12-week intervention which combined proactive psychiatry 
consultation and case management for patients with serious mental illness and cancer.
8. How useful was the intervention in the patient’s cancer care? 
Very useful                Somewhat useful                A little bit useful            Not at all useful
What was most useful?
___________________________________________________________________________
___________________________________________________________________________
What would you change to improve the intervention? 
___________________________________________________________________________
___________________________________________________________________________
9. How did the intervention impact the coordination of cancer and mental health care?
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______________________________________________________________________________
______________________________________________________________________________
10. How did the intervention impact your communication with the oncology team?
______________________________________________________________________________
______________________________________________________________________________
11. What worked best to communicate with you? Please check all that apply.
Phone            
Email
Text 
   
12. Have you seen XXXX since they completed the intervention? 
Yes
No
If not, why? 
______________________________________________________________________________
______________________________________________________________________________
13. What information, assistance or support would be helpful to you after your patient completes 
the intervention? 
______________________________________________________________________________
______________________________________________________________________________
14. What else, if anything, would you like to add that we have not discussed?
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
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Thank you for your participation in the study and for offering your feedback!
 
RANDOMIZED CONROLLED TRIAL
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IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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A. Clinician Fact Sheet 
Proactive Psychiatry Consultation and Case Management
for Patients with Serious Mental Illness and Cancer
HOW: Enrollment
* If you know of a patient who may be eligible for this study please contact:

Kelly Irwin, MD: kirwin1@partners.org, (617) 643-4453

Zoe Nelson: znelson@mgh.harvard.edu, (617) 726-2297
* Dr. Irwin will meet with patients at their convenience to confirm eligibility, explain study procedures, 
and obtain consent.
Study Activities 
* If randomized to receive the intervention: 

Participants will complete a psychiatric assessment with Dr. Irwin focused on decreasing 
symptoms and identifying barriers to care. Participants will complete a brief questionnaire at 
enrollment, 6 weeks, 12 weeks, and 24 weeks. 

Dr. Irwin will communicate recommendations to the participant’s oncology team and SW and 
remain available for ongoing consultation.

A social work case manager will communicate directly with participants to promote self-
management, coordinate care, bridge communication with providers and document in medical 
record.
* If randomized to receive enhanced usual care:

The treating oncologist will receive information about available mental health services at MGH
* All study participants can receive up to $50 for participation in the study.
WHO: Patients with SMI and recent diagnosis of cancer.

Diagnosis of psychotic disorder (schizophrenia, schizoaffective disorder), bipolar disorder, or 
major depressive disorder with prior psychiatric hospitalization 

Diagnosed with breast, lung, GI, or head and neck cancer that can potentially be treated with 
curative intent

Within 8 weeks of initial oncology consultation at MGH

Are ≥ 18 years of age 

Have verbal fluency in English 
WHY: Individuals with serious mental illness (SMI) die nearly 25 years younger than the general 
population and are significantly more likely to die from cancer. 

Diagnosed with more advanced stage cancer

Less likely to receive recommended cancer treatment

Collaborative care can improve cancer outcomes but hasn’t been tested in patients with SMI
WHAT: Randomized controlled trial combining screening, proactive psychiatry consultation at cancer 
diagnosis, and case management at the MGH Cancer Center.

Patient-centered care

Collaborative care strengthening communication among providers

Case manager linked to patient throughout cancer treatment
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Additional Questions
* If you have or encounter additional questions about this study, please contact Kelly Irwin and/or Zoe 
Nelson.
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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B. Patient Fact Sheet
Bridge: Early Psychiatry Consultation and Case Management 
Study for Patients with Cancer
Why participate in this study?

We’re conducting a study to understand if having a psychiatrist and case 
manager be part of your care team improves your cancer care. 
Who can participate? 

Patients who have recently been diagnosed with cancer and are getting their 
care at the MGH Cancer Center and have a history of mental health concerns, 
including depression, bipolar disorder, and schizophrenia. 
What does the study involve?

You have an equal chance of either: 
1) Having a psychiatrist and case manager be part of your cancer care team 
OR
2) Your oncologist being informed about available mental health supports 

You will be asked to complete 4 brief surveys over 24 weeks and be reimbursed 
$50. 

You may choose to identify a caregiver to participate in the study, but this is not 
required.

Participation involves no additional cost.
Do I have to participate?

Participation is completely voluntary and will not affect the care you receive at 
Massachusetts General Hospital or Department of Mental Health services.
What are the benefits of the study?

Your oncologist will receive information about mental health supports.  

Your participation can help us learn how to provide better care for people with 
cancer and mental health concerns.
What are the risks of the study? 

This is a minimal risk study. 

You may experience distress when responding to certain survey questions. You 
do not have to answer any questions that you find upsetting, and you may stop 
participating in the study at any time.  

In every study, there is a risk for some loss of privacy regarding your health 
information. The study team will take measures to minimize this risk as much as 
possible. 
Questions?  Please contact Zoe Nelson at (617) 726-2297, znelson@mgh.harvard.edu, or 
Dr. Kelly Irwin at (617) 643-4453, kirwin1@partners.org
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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C. Patient Recruitment Letter
Date
Joan R, Patient
29 High Street
Boston MA
Dear Mr./Ms. Patient,
I am writing to tell you about a research study that is being conducted at the Massachusetts General 
Hospital (MGH) Cancer Center by Kelly Irwin, MD, MPH, and a team of MGH researchers and 
clinicians.  You are receiving this letter because you have recently been diagnosed with lung, 
gastrointestinal, breast, or head and neck cancer and may receive cancer care at MGH. (Name of Dr/NP 
who gave permission to contact) believes you may be a good fit for this program and gave us permission 
to contact you.
  
The goal of this study is to understand if having a psychiatrist and case manager be part of your care team 
improves your cancer care.  
If you join this research study, you have an equal chance of either: 

Your oncologist being told about available mental health supports
OR 

Having a psychiatrist and case manager as part of your cancer care team. 
It will take you about 3 months to complete this research study. You will be asked to complete a set of 
questionnaires with the help of a clinician at 3 points in time; at the first visit (30-45 minutes), at 6 weeks 
(10 minutes), 3 month follow-up (20 minutes), and 6 month follow-up (20 minutes). Questionnaires can 
be completed via email, phone, or in-person, whichever you prefer.
Please contact the principal investigator Dr. Kelly Irwin, at (617) 643-4453 if you would like to learn 
more about the study.  Taking part in this research study is your choice and will not impact the care you 
receive at MGH.  If you do not want to participate in the research study, please call us within one week at 
(617) 726-2297.  If we do not hear from you, someone from the study team will call to see if you might 
want to hear more about the research study.  
Attached is a fact sheet which will provide more information about the study. Thank you for thinking 
about being part of this research study.
Sincerely,
 
Oncologist/Cancer Clinic Tumor Site Study Liaison
Kelly Irwin, MD, MPH
Massachusetts General Hospital Cancer Center
(617) 643-4453
Dana Farber
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IRB APPROVAL DATE: 10/01/202

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D. Caregiver Recruitment Letter
Date
Joan R, Caregiver
29 High Street
Boston MA
Dear Mr./Ms. Caregiver,
I am writing to tell you about a research study that is being conducted at the Massachusetts General 
Hospital (MGH) Cancer Center by Kelly Irwin, MD, MPH, and a team of MGH researchers and 
clinicians.  You are receiving this letter because you have been identified as a caregiver for someone who 
has recently been diagnosed with lung, gastrointestinal, breast, or head and neck cancer and may receive 
cancer care or monitoring at MGH. (Name of Dr/NP who gave permission to contact) believes him/her 
may be a good candidate for this program and (patient name) gave us permission to contact you.
  
The goal of this study is to understand if having a psychiatrist and case manager be part of a patient’s care 
team improves cancer care. 
If you join this research study, you have an equal chance of either: 

(Patient name)’s oncologist being told about available mental health supports
             OR

Having a psychiatrist and case manager as part of (patient name)’s cancer care team. 
It will take you about 3 months to complete this research study. You will be asked to complete a set of 
questionnaires with the help of a clinician at 3 points in time; at the first visit (30-45 minutes), at 6 weeks 
(10 minutes), and 3 month follow-up (20 minutes). Questionnaires can be completed via email, phone, or 
in-person, whichever you prefer.
Please contact the principal investigator Dr. Kelly Irwin, at (617) 643-4453 if you would like to learn 
more about the study. Taking part in this research study is your choice and will not impact the care 
(patient name) receives at MGH.  If you do not want to participate in the research study, please call us 
within one week at (617)726-2297.  If we do not hear from you, someone from the study will be calling to 
see if you might want to hear more about the research study.  
Attached is a fact sheet, which will provide more information about the study.  Thank you for thinking 
about being part of this research study.
Sincerely,
 
Oncologist/Cancer Clinic Tumor Site Study Liaison
Kelly Irwin, MD, MPH
Massachusetts General Hospital Cancer Center
(617) 643-4453
Dana Farber
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E. Clinician Recruitment Email
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients with 
Cancer
Dear Dr. ________,
Dr. Kelly Irwin is conducting a randomized controlled trial focused on patients with both cancer 
and serious mental illness (SMI) including schizophrenia, schizoaffective disorder, bipolar 
disorder, and major depressive disorder with prior hospitalization. The goal of the study is to 
pilot a randomized controlled trial to assess the acceptability and feasibility of an innovative 
model of care that incorporates proactive psychiatry consultation, collaborative care 
strengthening communication among providers, and engagement of a case manager at cancer 
diagnosis to optimize cancer care for patients with SMI. We are recruiting patients with SMI and 
a recent diagnosis of breast, lung, GI, or head and neck cancer (within 8 weeks of initial 
oncology consultation at the MGH Cancer Center). If you know of a patient who may be eligible 
for this study, please contact Dr. Irwin (kirwin1@partners.org, 617‐643‐4453) or Zoe Nelson 
(znelson@mgh.harvard.edu, 617‐726‐2297). Dr. Irwin will meet with patients at their 
convenience to confirm eligibility, explain study procedures, and obtain consent. If you have any 
additional questions about this study, please contact Dr. Irwin and/or Zoe Nelson.
Thank you,
F. Clinician Approval to Approach Email
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients with Cancer 
PI: Kelly E. Irwin, MD, MPH
Hello,
I am a research coordinator working with Dr. Kelly Irwin on a randomized controlled trial to 
investigate the effectiveness of proactive psychiatry consultation and case management for 
patients with serious mental illness and a recent cancer diagnosis.  
Your patient(s) [name] [MRN] is (are) potentially eligible for the study and I would like to 
approach him/her/them during his/her/their next appointment or call him/her/them on the phone 
to discuss the study. Please let me know at your earliest convenience if I have your permission to 
approach this patient. If I do not hear from you, I will request your permission in person to 
approach this patient.
Study participation does not preclude you or the rest of the patient’s care team for consulting 
psychiatry per your clinical judgment. 
Please feel free to let me know if you have any questions or concerns.
Thank you,
Zoe Nelson
Dana Farber
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IRB APPROVAL DATE: 10/01/202

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G. Clinician Email (Sent at Patient Consent)
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients with Cancer 
PI: Kelly E. Irwin, MD, MPH
Dear Dr. _______, 
Your patient XXXXX XXXXX has consented to Dr. Kelly Irwin’s randomized controlled trial: 
BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients with Cancer. 
XXXXX XXXXX has ____________ (psychiatric diagnosis). This trial does not preclude you 
from referring XXXX XXXX to available mental health services. To consult psychiatric 
oncology, you can place a consult through EPIC or call 617-643-6833. 
Thank you,
H. Response to Direct Referral to Principal Investigator 
Dear Dr. ________, 
Thank you for your referral. Dr. Irwin will only be able to see patients who are assigned to the 
intervention arm of the study. Please direct your referral to psychiatric oncology. To refer, please 
place a consult through EPIC or call 617-647-6833.
Thank you, 
I. Telephone Script (Recruitment)
Proactive Psychiatry Consultation Telephone Script
Hi is this (patient name)? My name is ___________ and I’m calling from Massachusetts General 
Hospital Cancer Center. I am calling about a letter that you may have received in the mail about 
a proactive psychiatry consultation program that you may be eligible for. Did you receive this 
letter?
NOT RECEIVED: I am happy to give you a brief overview if you have a couple of minutes. 
Would that be ok?
YES: Great. This program tests a new model of collaborative care that includes meeting 
with a psychiatrist and a social worker, known as our case manager, for patients at the 
MGH Cancer Center. We want to understand whether this model of care helps patients 
get the best possible cancer care. As part of the study, you have an equal chance of your 
oncologist being informed about mental health supports, or being connected to a 
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psychiatrist and a case manager who will be a part of your cancer care team. The 
psychiatrist and case manager will follow you for 3 months. We will ask you to complete 
a brief questionnaire at 3 different times during the study which will be coordinated with 
other appointments whenever possible, and can be completed via phone, email, or in-
person. Your participation is completely voluntary and will not impact the care you 
receive at MGH.
NO: Is there a better time for me to call you back?
YES RECEIVED: That’s great to hear! Did you have a chance to look over it and think about if 
you might be interested in participating?
YES: Wonderful! Do you have any questions about the program?
NO: I am happy to give you a brief overview if you have a couple of minutes. Would that 
be ok?
YES: Great. This program tests a new model of collaborative care that includes
proactive psychiatry consultation and a social work case manager for patients at
the MGH Cancer Center. We want to understand whether this model of care helps 
patients in navigating cancer care. As part of the study, you have an equal chance 
of your oncologist being informed about mental health supports, or being 
connected to a psychiatrist and a case manager who will be a part of your cancer 
care team. It will take you about 3 months to complete the study, and we will ask 
you to complete a brief questionnaire at 3 different points of the study, and can be 
completed via email, phone, or in-person. Of course, participation is completely 
voluntary and will not impact the care you receive at MGH.
NO: Is there a better time for me to call you back?
PATIENT WANTS TO ENROLL: Great. The next step is to arrange a time for you to meet 
with the psychiatrist or case manager and learn more about the study. We will try to coordinate 
the meeting with an upcoming oncology appointment. The total visit should take about one hour 
to complete. (If they have an upcoming appointment): I noticed you have an appointment on 
_____ (specific day), are you able to have the study appointment at that time? If not, when are 
you able to come in for this visit?
PATIENT INELIGIBLE/WANTS TO ENROLL: Unfortunately, you’re not eligible to 
participate in this study but we are happy to refer you to the oncology social worker.
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PATIENT WANTS TO THINK ABOUT IT: Sure, I understand. Can I give you a call in the 
next week to see what you are thinking and answer any questions?
PATIENT REFUSES: No problem. You do not have to answer this question, but, if you are 
willing, may I ask why? Your response to this question will not affect your care in any way.
VOICEMAIL: Hello this message is for (patient name). Hi (patient name), my name is ____, 
and I’m calling from the MGH Cancer Center about a letter that you should have received in the 
mail about a program that you may be eligible for. Please give a call back at _____________ and 
let me know a good time to contact you.
J. Patient Verbal Consent 
Bridge: Proactive Psychiatry Consultation and Case Management for Patients with Cancer
Principal Investigator: Kelly Irwin, MD, MPH
Contact information: Call 617-643-4453 
Purpose of the Research
It is challenging to cope with cancer.  We are conducting a study to understand if having a 
psychiatrist and case manager as part of your cancer care team at the time of cancer diagnosis might 
improve your cancer care.  Many people with illnesses like major depression, schizophrenia and 
bipolar disorder face barriers to receiving high quality cancer care. It can be difficult to get to 
appointments, have many different doctors, and experience depression or worry. Better 
communication between the patient, the oncology team, and mental health providers may improve 
care. As for all patients, it is important for people with mental illness to have access to high quality 
cancer treatment that is patient-centered and coordinated. Having a case manager and psychiatrist at 
the cancer center may help patients to receive the cancer care that they need.
Study Information
We are asking you to participate in this study because we think you may benefit from this 
intervention. This is a randomized research study, which means that study participants are assigned 
to a study group based on chance alone, like flipping a coin. If you choose to participate in this study, 
you will have an equal chance of being assigned to two options, either: One, you and your oncologist 
will be informed about mental health supports, or: Two, a psychiatrist and case manager will be a 
part of your cancer care team. If you are assigned to be connected to a psychiatrist and case manager, 
they will be available to you and communicate with your oncology team throughout your treatment.  
A case manager will help identify your needs, find resources, and communicate with the people who 
support you. 
The study team will tell you which option you will receive after you agree to participate in 
the study. All study participants (regardless of which study option they are assigned) will complete 
a set of questionnaires (about 30-45 minutes) and have a study clinician review their mental health 
history and communicate it to their oncologist. At 6 weeks, we will ask all study participants to 
complete a second set of questionnaires (about 10 minutes), at 12 weeks, a third set of questionnaires 
(about 20 minutes), and a fourth set at the 24 week time point (about 10 minutes) with study staff. 
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These questionnaires can be completed over the phone, by email, or in-person, whichever is least 
burdensome. With your permission, we will audio record parts of these assessments and certain study 
team visits during study participation. These recordings will be used for data analysis purposes only. 
If you do not want to be recorded, you may still participate. We will also ask you to identify a 
caregiver who is part of your cancer care. This can be a family member, friend, or community-based 
staff member who comes to visits with you or talks with your doctors. If you choose to include a 
caregiver in the study, the caregiver will be informed of your mental health and cancer diagnosis with 
your permission. Choosing not to identify a caregiver will not prevent you from participating in this 
study. 
Following the completion of this study, you may also be asked to participate in a 30-minute 
audio-recorded interview. You are free to decline. If you do participate, the hope is to better 
understand your experience with our study and how we might increase access to mental health and 
oncology care in other healthcare settings. If you are asked to participate in a 30-minute interview 
following the completion of the intervention, you will also be offered $30 in the form of cash or 
check to thank you for your time.
A description of this clinical trial will be available on http:www.ClinicalTrials.gov , as 
required by U.S. Law. This Web site will not include information that can identify you. At most, 
the Web site will include a summary of the results. You can search this Web site at any time.
Potential Risks and Discomforts
This study does not have any physical risks. You will not be injured or become physically 
sick because of participating in this study. Some of the items on the questionnaire may be upsetting. 
If any of the questions upset you, you can talk to your doctor or members of the study team. The 
research assistant and study clinician will be available to you throughout your participation in the 
study. You can also meet with our case manager or the principal investigator, a licensed psychiatrist, 
for additional support who can refer you to additional services as needed. If your responses indicate 
that you are in severe distress, a study clinician will call you to follow-up and assess your safety. At 
that point, you may be offered a referral to appropriate services, which you may accept or decline. 
Your healthcare team may be notified of this referral. 
Your responses to the questionnaires will be written down on paper or completed online.  
Your responses will not become part of your medical record, and they will not be seen by your care 
providers. We will also look at relevant parts of your MGH medical record, and store relevant data 
from your medical history.  We may request authorization to receive medical records and to share 
information/communicate with current providers for those who are not part of the MGH system. That 
data will be used only by study staff and will be protected by a password. Your identity will be kept 
confidential and we will be extremely careful to protect your privacy. If you receive the intervention, 
our psychiatrist and case manager will document their contacts with you in the medical record and 
share relevant recommendations with your oncology team. Taking part in this research study will not 
lead to added costs to you or your insurance company beyond usual care.
Benefits
All study participants will have access to an oncologist that is informed of available mental 
health supports at the cancer center. Additionally, participants who receive the intervention are linked 
to a psychiatrist and case manager as part of their cancer care team during cancer treatment. We will 
give you $20 after completing the first set of questionnaires, $10 after completing the third set of 
questionnaires, and $20 after completing the third set of questionnaires in the form of cash or check, 
to thank you for your time. 
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IRB APPROVAL DATE: 10/01/202

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Confidentiality 
There is little risk involved with study participation. We will be extremely careful to protect 
your privacy and health information by locking survey material and audio recorders in file cabinets 
and storing data and audio recordings on password protected computers. Only our study team can 
access this information.  Your responses will be kept confidential. You can stop participating in the 
study at any time. If the results of this research study are published in a medical journal, they will not 
identify individual patients. We share your health information only when we must, and we ask 
anyone who receives it from us to protect your privacy. For example, if we are concerned about your 
safety or the safety of others, we may need to discuss this information with your medical team. A 
Certificate of Confidentiality from the Department of Health and Human Services has been issued on 
this study as an additional protection of your privacy. Despite the study team’s precautions, you and 
your family must also actively protect your own privacy. 
Participation
Please note that participation in this study is completely voluntary and will not affect your 
medical care at the Massachusetts General Hospital or your access to Department of Mental Health 
services. You can stop participating in the research study at any time, and you can still get your 
medical care from your hospital or Investigator. We appreciate your time and consideration. 
Contact Information
If you have questions about the study, please contact:
Research assistant: Zoe Nelson (617-726-2297), M-F  9am-5pm. 
Principal investigator (licensed psychiatrist): Dr. Kelly Irwin (617-643-4453) 
For questions about your rights as a research participant, please contact a representative of 
the Office for Human Research Studies at DFCI (617) 632-3029. This can include questions about 
your participation in the study, concerns about the study, a research related injury, or if you feel/felt 
under pressure to enroll in this research study or to continue to participate in this research study.
K. Caregiver Verbal Consent 
Bridge: Proactive Psychiatry Consultation and Case Management for Patients with Cancer
Principal Investigator: Kelly Irwin, MD, MPH
Contact information: Call 617-643-4453 
Purpose of the Research
It is challenging to cope with cancer.  We are conducting a study to understand if having a 
psychiatrist and case manager as part of the cancer care team at the time of cancer diagnosis might 
improve patients’ cancer care. Many people with illnesses like major depression, schizophrenia and 
bipolar disorder face barriers to receiving high quality cancer care. It can be difficult to get to 
appointments, have many different doctors, and experience depression or worry. Better 
communication between the patient, caregivers, the oncology team, and mental health providers may 
improve care. As for all patients, it is important for people with mental illness to have access to high 
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quality cancer treatment that is patient-centered and coordinated.  We want to understand if is helpful 
for patients with mental illness to be connected to a case manager and psychiatrist at the cancer 
center. 
Study Information
We are asking you to participate in this study because you are a caregiver for an individual 
who may benefit from this intervention. This is a randomized research study, which means that study 
participants are assigned to a study group based on chance alone, like flipping a coin. If the patient 
agrees to participate in this study, he or she has an equal chance of receiving to two options, either: 
One, his/her oncologist will be informed about mental health supports, or: Two, a psychiatrist and 
case manager will be a part of his/her cancer care team. If the patient is assigned to be connected to a 
psychiatrist and case manager, they will be available to him/her and you as a caregiver and 
communicate with the oncology team throughout cancer treatment.  A case manager will help 
identify the patient’s needs, find resources, and communicate with the people who support him/her, 
such as yourself. 
The study team will tell you which option the patient will receive after he or she agrees to 
participate in the study. All study participants (both patients and caregivers), will complete a brief 
set of questionnaires by phone, email, or in-person, whichever is least burdensome, which will take 
about 30-45 minutes. In 6 weeks, we will ask you to complete a second set of questionnaires, which 
will take about 10 minutes. In three months, we will ask you to complete a third set of questionnaires 
with study staff, which will take about 20 minutes. These questionnaires can be completed over the 
phone, by email, or in-person, whichever is least burdensome. With your permission, we will audio 
record certain study team visits during study participation accessed only by study staff and used only 
for the study. If you do not want to be recorded, you may still participate.
Following the completion of this study, you may also be asked to participate in a 30-minute 
audio-recorded interview. You are free to decline. If you do participate, the hope is to better 
understand your experience with our study and how we might increase access to mental health and 
oncology care in other healthcare settings. If you are asked to participate in a 30-minute interview 
following the completion of the intervention, you will also be offered $30 in the form of cash or 
check to thank you for your time.
A description of this clinical trial will be available on http:www.ClinicalTrials.gov , as 
required by U.S. Law. This Web site will not include information that can identify you. At most, the 
Web site will include a summary of the results. You can search this Web site at any time.
Potential Risks and Discomforts
This study does not have any physical risks. You will not be injured or become physically 
sick because of participating in this study. Some of the items on the questionnaire may be upsetting. 
If any of the questions upset you, you can talk to members of the study team. The research assistant 
and study clinician will be available to you, and you can also meet with our case manager or the 
principal investigator, a licensed psychiatrist, for additional support who can refer you to additional 
services as needed. If your responses indicate that you are in severe distress, a study clinician will 
call you to follow-up and assess your safety. At that point, you may be offered a referral to 
appropriate services, which you may accept or decline. The patient’s healthcare team may be notified 
of this referral. If a study clinician is not able to reach you, they may reach out to your emergency 
contact or a member of the patient’s healthcare team. 
Your responses to the questionnaires will be written down on paper or completed online. 
Your identity will be kept confidential and we will be extremely careful to protect your privacy. That 
data will be used only by study staff and will be protected by a password.
Dana Farber
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Benefits
We hope that participation will help us to understand the needs of caregivers for patients with 
cancer and mental illness and help us to support patients coping with these challenges and the 
network of people who support them. We will give you $25 after completing the first set of 
questionnaires and another $25 after completing the third set of questionnaires in the form of cash or 
check, to thank you for your time.
Confidentiality 
There is little risk involved with study participation. We will be extremely careful to protect 
your privacy by locking survey material and audio recorders in file cabinets and storing data and 
recordings on password protected computers. Only our study team can access this information.  Your 
responses will be kept confidential. If the results of this research study are published in a medical 
journal, they will not identify individuals. A Certificate of Confidentiality from the Department of 
Health and Human Services has been issued on this study as an additional protection of your privacy. 
Despite the study team’s precautions, you and your family must also actively protect your own 
privacy. 
Participation
Please note that participation in this study is completely voluntary. You can stop participating 
in the research study at any time, and leaving the research study will not affect the patient’s medical 
care at Massachusetts General Hospital or the patient’s access to Department of Mental Health 
services. You can still get your medical care from your hospital or Investigator. We appreciate your 
time and consideration. 
Contact Information
If you have questions about the study, please contact:
Research assistant: Zoe Nelson (617-726-2297), M-F  9am-5pm. 
Principal investigator (licensed psychiatrist): Dr. Kelly Irwin (617-643-4453) 
 
For questions about your rights as a research participant, please contact a representative of 
the Office for Human Research Studies at DFCI (617) 632-3029. This can include questions about 
your participation in the study, concerns about the study, a research related injury, or if you feel/felt 
under pressure to enroll in this research study or to continue to participate in this research study. 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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L. Participant Written Consent for Recordings
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M. Assessment of Capacity to Participate in Clinical Research 
Proposed questions to assess capacity to participate in clinical research:
1)
Do you want to participate in this research study?
2)
What is the study about?
3)
What benefits do you get from participating in this study?
4)
Why do you want to participate?
In his/her answers to the above questions, the research subject has indicated that

He/she communicates the choice to participate in the proposed research study.
Participation is his/her choice.
The participation is voluntary.

He/she has a factual understanding of the research study.
Aims
Institutional affiliations of the researcher
Methods 
Anticipated benefits
Possible conflicts of interest
Potential risks or discomfort it may entail

He/she has an appreciation of the significance of the facts about research participation.
This is a research study, not treatment.
There might be no immediate benefit.

He/she is able to reason about research participation.
Cognitive limitations considered.
Limitations due to psychosis considered.
Limitations due to affective state considered.
SUMMARY STATEMENT 

Informed consent obtained.

Subject has capacity to provide informed consent to participate in research despite the 
following (potentially limiting) factors:
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
I, the undersigned representative of the Investigator and staff member of the research project attest 
that the afore signed individual showed understanding of the research project and what is involved in 
participating as evidenced by replies to queries on each section as the informed consent was explained. 
Further I attest that the individual agreed to participate voluntarily
____________________________________
__________________
Signature
Date
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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N. Patient Baseline Questionnaire
PATIENT ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: Baseline
 
 Patient-Reported Measures
Date
1
BACKGROUND INFORMATION
 
2
PSYCH RESOURCE UTILIZATION QUESTIONNAIRE
 
3
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
4
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
5
UCLA 3-ITEM LONELINESS SCALE
6
PATIENT ACTIVATION MEASURE (PAM 10)
 
7
THE M.D. ANDERSON SYMPTOM INVENTORY (MDASI)
 
8
DISCRIMINATION IS MEDICAL SETTINGS SCALE (DMS)
10
HEALTH LEADS SOCIAL NEED SCREENING TOOLKIT
11
PARTICIPANT LOCATOR FORM
 
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Demographics
1. Gender: __________
Please check the appropriate box or boxes.
2. Ethnicity
Hispanic or Latino
Not Hispanic or Latino
3. Race (please check all that apply)
American Indian or Alaskan native
Asian
African American or Black
Native Hawaiian or other Pacific 
Islander
White
Other (please specify) _____________
4. Religion
Catholic Christian
Other Christian (such as Protestant, 
Orthodox, etc.)
Jewish
Muslim
Atheist
None
Other (please 
specify)_______________
5. Current relationship status
Married or living with someone as if 
married
Non-cohabiting relationship
Single, never married
Divorced/Separated
Loss of long term partner/ Widowed
6. Please indicate your highest or current 
education level
11th grade or less
High school graduate or GED
2 years of college/AA 
degree/Technical    school training
College graduate (BA or BS)
Masters degree
Doctorate/Medical degree/Law degree
7. What is your annual combined 
household income?
Less than $25,000
$25,000 – 50,000
$50,000 -100,000
$100,000 – 150,000
Greater than $150,000
8. Do you currently have stable housing 
that you own, rent, or stay in as part of a 
household?
Yes
No
9. Please indicate who you live with (you 
may check more than one box)
By myself
Partner/Spouse
Roommate/Friend
Children under 18
Children over 18
Group home/assisted living/nursing 
home
Parent
Other (please specify) _____________
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10. Have you ever lacked stable housing in 
the past (not known where you would be 
sleeping night to night)?
Yes
No
11. Current employment status
(please check all that apply): 
Employed (full-time or part-time)
Caring for home or family (not 
currently working and not looking for 
paid work)
Unemployed and looking for work
Unable to work due to illness or 
disability
Retired
Student
Other (please specify) _____________
12.  Aside from mental health professionals, 
is there a medical health professional you 
see most often (a primary care provider)?
Yes
No
13. If yes, who is your primary care 
provider?
________________________________
14.  When was your last visit to your 
primary care provider?
_________________________________
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Resource Utilization Questionnaire
1. Are you currently receiving any of the following mental health services at MGH? Please 
check all that apply: 
No services at this time
Support Group
Social Worker
Psychologist
Psychiatrist
Other:___________________
2. Are you currently receiving any of the following mental health services outside of MGH? 
Please check all that apply:
No services at this time
Support Group
Social Worker
Psychologist
Psychiatrist
Case manager
Day program
Visiting nurse (VNA)
Department of Mental Health (DMH) Services
Other:___________________
3. Have you ever been hospitalized for mental illness (such as depression, anxiety, bipolar 
disorder, or schizophrenia)?
Yes
No
3a. If yes,  please list the number of hospitalizations: 
3b. Briefly, what was the reason for the hospitalization(s)?__________________
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3c. When was your last hospitalization? ___________________
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, 
IN THE PAST WEEK? Please read each item and circle one number in each row to 
indicate your answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a 
lot more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
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IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
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IRB APPROVAL DATE: 10/01/202

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UCLA 3-ITEM LONELINESS SCALE
INSTRUCTIONS: Please read each item below and circle one number in each row to 
indicate how often each statement is descriptive of you.
1 indicates “I hardly ever feel this way”
2 indicates “I sometimes feel this way” 
3 indicates “I often feel this way”
Hardly 
ever
Some of 
the time
Often
1. How often do you feel that you lack companionship?
1
2
3
2. How often to you feel left out?
1
2
3
3. How often do you feel isolated from others?
1
2
3
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Patient Activation Measure (PAM 10)
Below are some statements that people sometimes make when they talk about their health. Please 
indicate how much you agree or disagree with each statement as it applies to you personally by 
circling your answer. Your answers should be what is true for you and not just what you think 
the doctor wants you to say.
If the statement does not apply to you, circle N/A. 
1. When all is said and done, I am the person who is 
responsible for taking care of my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in my own health care is the 
most important thing that affects my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I know what each of my prescribed medications do.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I am confident that I can tell whether I need to go to 
the doctor or whether I can take care of a health problem 
myself.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident that I can tell a doctor concerns I have 
even when he or she does not ask.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident that I can follow through on medical 
treatments I may need to do at home.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I have been able to maintain (keep up with) lifestyle 
changes, like eating right or exercising.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I know how to prevent problems with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I am confident I can figure out solutions when new 
problems arise with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I am confident that I can maintain lifestyle changes, 
like eating right and exercising, even during times of 
stress.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
MDASI
Part I. How severe are your symptoms?
People with cancer frequently have symptoms that are caused by their disease or by their treatment. 
We ask you to rate how severe the following symptoms have been in the last 24 hours. Please fill in 
the circle below from 0 (symptom has not been present) to 10 (the symptoms was as bad as you can 
imagine it could be) for each item.
Not 
Present
As Bad As You 
Can Imagine
0
1
2
3
4
5
6
7
8
9
10
1. Your pain at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
2. Your fatigue (tiredness) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
3. Your nausea at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
4. Your disturbed sleep at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
5. Your feelings of being distressed 
(upset) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
6. Your shortness of breath at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
7. Your problem with remembering 
things at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
8. Your problem with lack of appetite 
at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
9. Your feeling drowsy (sleepy) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
10.Your having a dry mouth at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
11.Your feeling sad at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
12.Your vomiting at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
13.Your numbness or tingling at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Part II. How have your symptoms interfered with your life?
Symptoms frequently interfere with how we feel and function. How much have your symptoms 
interfered with the following items in the last 24 hours? Please select a number from 0 
(symptoms have not interfered) to 10 (symptoms interfered completely) for each item.
Did Not 
Interfere
Interfered 
Completely
0
1
2
3
4
5
6
7
8
9
10
14.General activity?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
15.Mood?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
16.Work (including work around the 
house)?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
17.Relations with other people?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
18.Walking?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
19.Enjoyment of life?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Discrimination in Medical Settings Scale
In your prior experiences receiving health care, how often did the following experiences happen 
to you?
Never
Rarely
Sometimes
Most of 
the time
Always
1
You are treated with less courtesy 
than other people.
1
2
3
4
5
2
You are treated with less respect than 
other people.
1
2
3
4
5
3
You receive poorer service than 
others.
1
2
3
4
5
4
A doctor or nurse acts as if he or she 
thinks you are not smart.
1
2
3
4
5
5
A doctor or nurse acts as if he or she 
is afraid of you.
1
2
3
4
5
6
A doctor or nurse acts as if he or she 
is better than you.
1
2
3
4
5
7
You feel like a doctor or nurse is not 
listening to what you were saying.
1
2
3
4
5
Follow-up Question (complete this section only if you answered “Sometimes” or more 
frequently to at least one question.): What do you think is the main reason for these experiences? 
(YOU MAY CHECK MORE THAN ONE). 
 
RECOMMENDED OPTIONS 
1. Your Ancestry or National Origins 
2. Your Gender  
3. Your Race 
4. Your Age 
5. Your Mental Illness
6. Your Religion 
7. Your Weight 
8. Some other Aspect of Your Physical Appearance 
9. Your Sexual Orientation 
10. Your Education or Income Level
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Health Leads Social Need Screening Toolkit
Preferred Language:
Best time to call:
Yes
No
1. In the last 12 months, did you ever eat less than you felt you should 
because there wasn’t enough money or food?
2. In the last 12 months, has your utility company shut off your service 
for not paying your bills?
3. Are you worried that in the next 2 months, you may not have stable 
housing?
4. Do problems getting child care make it difficult for you to work or 
study? 
(leave blank if you do not have children)
5. In the last 12 months, have you needed to see a doctor, but could not 
because of cost?
6. In the last 12 months, have you ever had to go without health care 
because you didn’t have a way to get there?
7. Do you ever need help reading hospital materials?
8. Are you afraid you might be hurt in your apartment building or 
house?
9. If you checked YES to any boxes above, would you like to receive 
assistance with any of these needs?
10. Are any of your needs urgent?
For example: I don’t have food tonight, I don’t have a place to sleep 
tonight
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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PARTICIPANT LOCATOR FORM
Participant name: 
__________________________________________________
Home address: 
__________________________________________________
  
(Street)
    
(Apt.)
__________________________________________________
  
(City, State, Zip)
    
Preferred phone: 
__________________________________________________
Alternate phone: 
__________________________________________________
Email: (will only be used if necessary):  ____________________________________
IN CASE WE HAVE TROUBLE REACHING YOU, PLEASE PROVIDE ONE OTHER PERSON 
WE COULD CONTACT (This is optional and will not affect your participation in the research 
study).
Contact name:      __________________________________________________
(Last)
    
 
(First)     
 (M.I.)
Relationship to participant:   __________________________________________
Preferred phone:    __________________________________________________
Alternate phone:    __________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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O. Patient 6-Week Questionnaire
PATIENT ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 6 Weeks
 
Patient-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
PATIENT ACTIVATION MEASURE (PAM 10)
 
4
THE M.D. ANDERSON SYMPTOM INVENTORY (MDASI)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Caregiver Change
Do you have a different primary caregiver than you had when you completed the last survey?
Yes
No
If no, please skip to the next page.
If yes, please explain why: ________________________________________________________
When did this change occur? ____________________________________________________
Who is your new caregiver? _____________________________________________________
Please indicate your relationship with the new caregiver: 
Married or living as if married
Non-cohabitating relationship
Divorced/Separate
Friend
Family Member
Parent (mother or father)
Child (daughter or son)
Sibling (brother or sister)
Other relative
The caregiver is a community mental health worker
Other: ____________
Do you live with the caregiver?
Yes
No
Caregiver contact information:
Home address: 
__________________________________________________
  
(Street)
    
(Apt.)
__________________________________________________
  
(City, State, Zip)
    
Preferred phone: 
__________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Alternate phone: 
__________________________________________________
Email (will only be used if necessary):   ___________________________________
Time Spent with Caregiver
We understand that time spent with your caregiver may change over time. Think about the past 
two weeks. Please estimate the number of hours per week (on average) that your caregiver 
provided direct care (in-person or virtual) to you:
Less than 1 hour per week
1-2 hours per week
2-5 hours per week
5-10 hours per week
10-15 hours per week
Over 15 hours per week 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, 
IN THE PAST WEEK? Please read each item and circle one number in each row to 
indicate your answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a 
lot more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Patient Activation Measure (PAM 10)
Below are some statements that people sometimes make when they talk about their health. Please 
indicate how much you agree or disagree with each statement as it applies to you personally by 
circling your answer. Your answers should be what is true for you and not just what you think 
the doctor wants you to say.
If the statement does not apply to you, circle N/A. 
1. When all is said and done, I am the person who is 
responsible for taking care of my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in my own health care is the 
most important thing that affects my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I know what each of my prescribed medications do.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I am confident that I can tell whether I need to go to 
the doctor or whether I can take care of a health problem 
myself.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident that I can tell a doctor concerns I have 
even when he or she does not ask.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident that I can follow through on medical 
treatments I may need to do at home.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I have been able to maintain (keep up with) lifestyle 
changes, like eating right or exercising.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I know how to prevent problems with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I am confident I can figure out solutions when new 
problems arise with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I am confident that I can maintain lifestyle changes, 
like eating right and exercising, even during times of 
stress.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
MDASI
Part I. How severe are your symptoms?
People with cancer frequently have symptoms that are caused by their disease or by their treatment. 
We ask you to rate how severe the following symptoms have been in the last 24 hours. Please fill in 
the circle below from 0 (symptom has not been present) to 10 (the symptoms was as bad as you can 
imagine it could be) for each item.
Not 
Present
As Bad As You 
Can Imagine
0
1
2
3
4
5
6
7
8
9
10
1. Your pain at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
2. Your fatigue (tiredness) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
3. Your nausea at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
4. Your disturbed sleep at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
5. Your feelings of being distressed 
(upset) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
6. Your shortness of breath at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
7. Your problem with remembering 
things at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
8. Your problem with lack of appetite 
at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
9. Your feeling drowsy (sleepy) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
10.Your having a dry mouth at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
11.Your feeling sad at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
12.Your vomiting at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
13.Your numbness or tingling at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
Part II. How have your symptoms interfered with your life?
Symptoms frequently interfere with how we feel and function. How much have your symptoms 
interfered with the following items in the last 24 hours? Please select a number from 0 
(symptoms have not interfered) to 10 (symptoms interfered completely) for each item.
Did Not 
Interfere
Interfered 
Completely
0
1
2
3
4
5
6
7
8
9
10
14.General activity?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
15.Mood?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
16.Work (including work around the 
house)?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
17.Relations with other people?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
18.Walking?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
19.Enjoyment of life?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
P. Patient 12 Week Questionnaire
PATIENT ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 12 Weeks
 
Patient-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
UCLA 3-ITEM LONELINESS SCALE
4
PATIENT ACTIVATION MEASURE (PAM 10)
 
5
THE M.D. ANDERSON SYMPTOM INVENTORY (MDASI)
6
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-
TREATMENT SATISFACTION-PATIENT SATISFACTION (FACIT-TS-PS)
7
TRUST IN PHYSICIAN SCALE (TPS)
8
PSYCH RESOURCE UTILIZATION QUESTIONNAIRE
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Caregiver Change
Do you have a different primary caregiver than you had when you completed the last survey?
Yes
No
If no, please skip to the next page.
If yes, please explain why: ________________________________________________________
When did this change occur? ____________________________________________________
Who is your new caregiver? _____________________________________________________
Please indicate your relationship with the new caregiver: 
Married or living as if married
Non-cohabitating relationship
Divorced/Separate
Friend
Family Member
Parent (mother or father)
Child (daughter or son)
Sibling (brother or sister)
Other relative
The caregiver is a community mental health worker
Other: ____________
Do you live with the caregiver?
Yes
No
Caregiver contact information:
Home address: 
__________________________________________________
  
(Street)
    
(Apt.)
__________________________________________________
  
(City, State, Zip)
    
Preferred phone: 
__________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Alternate phone: 
__________________________________________________
Email (will only be used if necessary):   ___________________________________
Time Spent with Caregiver
We understand that time spent with your caregiver may change over time. Think about the past 
two weeks. Please estimate the number of hours per week (on average) that your caregiver 
provided direct care (in-person or virtual) to you:
Less than 1 hour per week
1-2 hours per week
2-5 hours per week
5-10 hours per week
10-15 hours per week
Over 15 hours per week 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, 
IN THE PAST WEEK? Please read each item and circle one number in each row to 
indicate your answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a 
lot more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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UCLA 3-ITEM LONELINESS SCALE
INSTRUCTIONS: Please read each item below and circle one number in each row to 
indicate how often each statement is descriptive of you.
1 indicates “I hardly ever feel this way”
2 indicates “I sometimes feel this way” 
3 indicates “I often feel this way”
Hardly 
ever
Some of 
the time
Often
1. How often do you feel that you lack companionship?
1
2
3
2. How often do you feel left out?
1
2
3
3. How often do you feel isolated from others?
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Patient Activation Measure (PAM 10)
Below are some statements that people sometimes make when they talk about their health. Please 
indicate how much you agree or disagree with each statement as it applies to you personally by 
circling your answer. Your answers should be what is true for you and not just what you think 
the doctor wants you to say.
If the statement does not apply to you, circle N/A. 
1. When all is said and done, I am the person who is 
responsible for taking care of my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in my own health care is the 
most important thing that affects my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I know what each of my prescribed medications do.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I am confident that I can tell whether I need to go to 
the doctor or whether I can take care of a health problem 
myself.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident that I can tell a doctor concerns I have 
even when he or she does not ask.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident that I can follow through on medical 
treatments I may need to do at home.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I have been able to maintain (keep up with) lifestyle 
changes, like eating right or exercising.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I know how to prevent problems with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I am confident I can figure out solutions when new 
problems arise with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I am confident that I can maintain lifestyle changes, 
like eating right and exercising, even during times of 
stress.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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MDASI
Part I. How severe are your symptoms?
People with cancer frequently have symptoms that are caused by their disease or by their treatment. 
We ask you to rate how severe the following symptoms have been in the last 24 hours. Please fill in 
the circle below from 0 (symptom has not been present) to 10 (the symptoms was as bad as you can 
imagine it could be) for each item.
Not 
Present
As Bad As You 
Can Imagine
0
1
2
3
4
5
6
7
8
9
10
1. Your pain at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
2. Your fatigue (tiredness) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
3. Your nausea at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
4. Your disturbed sleep at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
5. Your feelings of being distressed 
(upset) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
6. Your shortness of breath at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
7. Your problem with remembering 
things at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
8. Your problem with lack of appetite 
at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
9. Your feeling drowsy (sleepy) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
10.Your having a dry mouth at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
11.Your feeling sad at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
12.Your vomiting at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
13.Your numbness or tingling at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Part II. How have your symptoms interfered with your life?
Symptoms frequently interfere with how we feel and function. How much have your symptoms 
interfered with the following items in the last 24 hours? Please select a number from 0 
(symptoms have not interfered) to 10 (symptoms interfered completely) for each item.
Did Not 
Interfere
Interfered 
Completely
0
1
2
3
4
5
6
7
8
9
10
14.General activity?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
15.Mood?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
16.Work (including work around the 
house)?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
17.Relations with other people?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
18.Walking?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
19.Enjoyment of life?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
FACIT-TS-PS (Version 4)
These questions are about the quality of the cancer care services you are currently receiving. All 
of your responses will be kept confidential. Please mark one answer for each of the following 
questions.
Please list the name of your oncologist(s): ________________________
Physician Communication
No, not at 
all
Yes, but 
not as 
much as I 
wanted
Yes, 
almost as 
much as I 
wanted
Yes, and 
as much 
as I 
wanted
TS9
Did your doctor(s) give explanations that you 
could understand?
.....................................................................................
0
1
2
3
TS10
Did your doctor(s) explain the possible benefits of 
your treatment?
.....................................................................................
0
1
2
3
TS11
Did your doctor(s) explain the possible side effects 
or risks of your treatment?
.....................................................................................
0
1
2
3
TS12
Did you have an opportunity to ask questions?
.....................................................................................
0
1
2
3
TS13
Did you get to say the things that were important 
to you?
....................................................................................
0
1
2
3
TS14
Did your doctor(s) seem to understand what was 
important to you?
....................................................................................
0
1
2
3
TS15
Did your doctor(s) show genuine concern for you?
....................................................................................
0
1
2
3
TS16
Did your doctor(s) seem to understand your needs?
....................................................................................
0
1
2
3
TS18
Were you able to talk to your doctor(s) when you 
needed to?
....................................................................................
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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TS27
Were you encouraged to participate in decisions 
about your health care?
....................................................................................
0
1
2
3
TS28
Did you have enough time to make decisions about 
your health care?
....................................................................................
0
1
2
3
TS30
Did your doctor(s) seem to respect your opinions?
....................................................................................
0
1
2
3
Confidence and Trust
No, not 
at all
Yes, but 
not as 
much as 
I wanted
Yes, 
almost as 
much as 
I wanted
Yes, and as 
much as I 
wanted
TS34
Did you feel that the treatment staff answered your 
questions honestly?
....................................................................................
0
1
2
3
TS35
Did the treatment staff respect your privacy?
....................................................................................
0
1
2
3
TS36
Did you have confidence in your doctor(s)?
....................................................................................
0
1
2
3
TS37
Did you trust your doctor(s)' suggestions for 
treatment?
0
1
2
3
Overall
No
Maybe
Yes
TS38
Would you recommend this clinic or office to 
others?
..............................................................................
0
1
2
TS39
Would you choose this clinic or office again?
..............................................................................
0
1
2
Poor
Fair
Good
Very 
Good
Excellent
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
TS40
How do you rate the care you received?
...............................................................................
0
1
2
3
4
Thank you! Do you have any comments? 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Trust in Physician Scale (TPS)
Below are some statements referring to your cancer care doctors. Please rate how 
much you agree or disagree with each statement. Response choices vary from “strongly 
disagree” to “strongly agree”.
1. I doubt that my doctor really cares 
about me as a person
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
2. My doctor is usually considerate of my 
needs and puts them first
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
3. I trust my doctor so much that I always 
try to follow his/her advice
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
4. If my doctor tells me something is so, 
then it must be true
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
5. I sometimes distrust my doctor’s 
opinion and would like a second one
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
6. I trust my doctor’s judgment about my 
medical care
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
7. I feel my doctor does not do everything 
he/she should for my medical care
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
8. I trust my doctor to put my medical 
needs above all other considerations 
when treating my medical problems
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
9. My doctor is a real expert in taking care 
of medical problems like mine
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
10. I trust my doctor to tell me if a mistake 
was made about my treatment
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
11. I sometimes worry that my doctor may 
not keep the information we discuss 
totally private
Disagree       Disagree     Agree       Agree       N/A
Strongly                                           Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Resource Utilization Questionnaire
Please answer the following questions if you have a psychiatrist, social worker, case manager, or 
therapist that you saw before your diagnosis of cancer.
1. How many times have you seen your psychiatrist since you learned of your cancer 
diagnosis?

I did not have a psychiatrist before my cancer diagnosis

Not at all

Once

2-5 times

More than 5 times
2. How many times have you seen or talked with your therapist or social worker since 
you learned of your cancer diagnosis?

I did not have a therapist or social worker before my cancer diagnosis

Not at all

Once

2-5 times

More than 5 times
3. Have you been hospitalized for mental illness (such as depression, anxiety, bipolar 
disorder, or schizophrenia) since you learned of your cancer diagnosis?

Yes

No
3a. If yes, please list the number of hospitalizations: ___________
3b. Briefly, what was the reason for the hospitalization(s)? 
_____________________________________________________________________________
3c. When was your last hospitalization? _____________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Q. Patient 12-week Exit Survey (Bridge arm only)
PATIENT -12-WEEK PARTICIPANT FEEDBACK
We are now interested to know about your satisfaction with different aspects of this intervention.  There is 
no right or wrong answer. Your answers will be kept confidential and will not affect your participation in 
future research studies, or your access to care at MGH or affiliated sites. As a reminder, you 
participated in a research study of an intervention that involved a psychiatrist (Dr. Irwin or Dr. 
Marouf) and a social work case manager (Amy Corveleyn) in your cancer care team.
1.
From your perspective, how useful was the intervention in your cancer care?   
Very useful                Somewhat useful                A little bit useful                    Not at all useful
2.  How useful were the following parts of the intervention? 
3. What did you think was the most useful part about the intervention?
____________________________________________________________________________________
____________________________________________________________________________________
4. What do you feel could be improved about the intervention?  
____________________________________________________________________________________
____________________________________________________________________________________
5. What else, if anything, would you like to add about the intervention that we did not discuss? 
____________
Thank you for being a part of the Proactive Psychiatry Consultation for Patients with Cancer Study. Your 
feedback is valuable to us and we appreciate your responses.
Involving psychiatry early in your cancer care 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful 
Don’t know/ Does 
not apply to me
Meeting with your psychiatrist, (Dr. Irwin/Dr. Marouf) 
in person
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Being able to reach your psychiatrist (Dr. Irwin/Dr. 
Marouf) by phone or email
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Being able to reach your case manager, Amy, by 
phone or email
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Communicating with your community mental health 
clinicians 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Meeting with your cancer and psychiatry teams 
together
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Helping with barriers to your care (e.g. rides to the 
hospital, insurance, housing)
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Addressing your psychiatric symptoms and 
medications 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Involving your caregiver in your cancer care 
Very 
useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
R. Patient 24 Week Questionnaire
PATIENT ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 24 Weeks
 
Patient-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
3
UCLA 3-ITEM LONELINESS SCALE
4
PATIENT ACTIVATION MEASURE (PAM 10)
5
THE M.D. ANDERSON SYMPTOM INVENTORY (MDASI)
6
PSYCH RESOURCE UTILIZATION QUESTIONNAIRE
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Caregiver Change
Do you have a different primary caregiver than you had when you completed the last survey?
Yes
No
If no, please skip to the next page.
If yes, please explain why: ________________________________________________________
When did this change occur? ____________________________________________________
Who is your new caregiver? _____________________________________________________
Please indicate your relationship with the new caregiver: 
Married or living as if married
Non-cohabitating relationship
Divorced/Separate
Friend
Family Member
Parent (mother or father)
Child (daughter or son)
Sibling (brother or sister)
Other relative
The caregiver is a community mental health worker
Other: ____________
Do you live with the caregiver?
Yes
No
Caregiver contact information:
Home address: 
__________________________________________________
  
(Street)
    
(Apt.)
__________________________________________________
  
(City, State, Zip)
    
Preferred phone: 
__________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Alternate phone: 
__________________________________________________
Email (will only be used if necessary):   ___________________________________
Time Spent with Caregiver
We understand that time spent with your caregiver may change over time. Think about the past 
two weeks. Please estimate the number of hours per week (on average) that your caregiver 
provided direct care (in-person or virtual) to you:
Less than 1 hour per week
1-2 hours per week
2-5 hours per week
5-10 hours per week
10-15 hours per week
Over 15 hours per week 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, 
IN THE PAST WEEK? Please read each item and circle one number in each row to 
indicate your answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing 
things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or 
sleeping too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you 
are a failure or have let yourself or your 
family down
0
1
2
3
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the 
opposite – being so fidgety or restless 
that you have been moving around a 
lot more than usual
0
1
2
3
9. Thoughts that you would be better off 
dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following 
problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
UCLA 3-ITEM LONELINESS SCALE
INSTRUCTIONS: Please read each item below and circle one number in each row to 
indicate how often each statement is descriptive of you.
1 indicates “I hardly ever feel this way”
2 indicates “I sometimes feel this way” 
3 indicates “I often feel this way”
Hardly 
ever
Some of 
the time
Often
1. How often do you feel that you lack companionship?
1
2
3
2. How often do you feel left out?
1
2
3
3. How often do you feel isolated from others?
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Patient Activation Measure (PAM 10)
Below are some statements that people sometimes make when they talk about their health. Please 
indicate how much you agree or disagree with each statement as it applies to you personally by 
circling your answer. Your answers should be what is true for you and not just what you think 
the doctor wants you to say.
If the statement does not apply to you, circle N/A. 
1. When all is said and done, I am the person who is 
responsible for taking care of my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in my own health care is the 
most important thing that affects my health.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I know what each of my prescribed medications do.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I am confident that I can tell whether I need to go to 
the doctor or whether I can take care of a health problem 
myself.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident that I can tell a doctor concerns I have 
even when he or she does not ask.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident that I can follow through on medical 
treatments I may need to do at home.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I have been able to maintain (keep up with) lifestyle 
changes, like eating right or exercising.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I know how to prevent problems with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I am confident I can figure out solutions when new 
problems arise with my health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I am confident that I can maintain lifestyle changes, 
like eating right and exercising, even during times of 
stress.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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MDASI
Part I. How severe are your symptoms?
People with cancer frequently have symptoms that are caused by their disease or by their treatment. 
We ask you to rate how severe the following symptoms have been in the last 24 hours. Please fill in 
the circle below from 0 (symptom has not been present) to 10 (the symptoms was as bad as you can 
imagine it could be) for each item.
Not 
Present
As Bad As You 
Can Imagine
0
1
2
3
4
5
6
7
8
9
10
1. Your pain at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
2. Your fatigue (tiredness) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
3. Your nausea at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
4. Your disturbed sleep at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
5. Your feelings of being distressed 
(upset) at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
6. Your shortness of breath at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
7. Your problem with remembering 
things at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
8. Your problem with lack of appetite 
at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
9. Your feeling drowsy (sleepy) at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
10.Your having a dry mouth at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
11.Your feeling sad at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
12.Your vomiting at its WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
13.Your numbness or tingling at its 
WORST?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Part II. How have your symptoms interfered with your life?
Symptoms frequently interfere with how we feel and function. How much have your symptoms 
interfered with the following items in the last 24 hours? Please select a number from 0 
(symptoms have not interfered) to 10 (symptoms interfered completely) for each item.
Did Not 
Interfere
Interfered 
Completely
0
1
2
3
4
5
6
7
8
9
10
14.General activity?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
15.Mood?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
16.Work (including work around the 
house)?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
17.Relations with other people?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
18.Walking?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
19.Enjoyment of life?
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Ο
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Resource Utilization Questionnaire
Please answer the following questions if you have a psychiatrist, social worker, case manager, or 
therapist that you saw before your diagnosis of cancer.
1. How many times have you seen your psychiatrist since you learned of your cancer 
diagnosis?

I did not have a psychiatrist before my cancer diagnosis

Not at all

Once

2-5 times

More than 5 times
2. How many times have you seen or talked with your therapist or social worker since 
you learned of your cancer diagnosis?

I did not have a therapist or social worker before my cancer diagnosis

Not at all

Once

2-5 times

More than 5 times
3. Have you been hospitalized for mental illness (such as depression, anxiety, bipolar 
disorder, or schizophrenia) since you learned of your cancer diagnosis?

Yes

No
3a. If yes, please list the number of hospitalizations: ___________
3b. Briefly, what was the reason for the hospitalization(s)? 
_____________________________________________________________________________
3c. When was your last hospitalization? _____________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
S. Caregiver Baseline Questionnaire
Date: _________
Study ID: ______
Time point: Baseline
 
 Caregiver-Reported Measures
Date
1
BACKGROUND INFORMATION
 
2
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
3
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
4
UCLA 3-ITEM LONELINESS SCALE
5
CAREGIVER PATIENT ACTIVATION MEASURE (CG-PAM 10)
 
6
CAREGIVER REACTION ASSESSMENT
 
7
FAMCARE 2
8
PEARLIN MASTERY SCALE
9
PARTICIPANT LOCATOR FORM
 
CAREGIVER ASSESSMENT CHECKLIST
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Version 6.0, 3/26/2019
Demographics
Please check the appropriate box or boxes.
1. Date of Birth: ________
2. Gender: __________
3. Ethnicity
Hispanic or Latino
Not Hispanic or Latino
4. Race (please check all that apply)
American Indian or Alaskan native
Asian
African American or Black
Native Hawaiian or other Pacific 
Islander
White
Other (please specify) _____________
5. Religion
Catholic Christian
Other Christian (such as Protestant, 
Orthodox, etc.)
Jewish
Muslim
Atheist
None
Other (please 
specify)_______________
6. Current relationship status
Married or living with someone as if 
married
Non-cohabiting relationship
Single, never married
Divorced/Separated
Loss of long term partner/ Widowed
7. Please indicate your highest or current 
education level
11th grade or less
High school graduate or GED
2 years of college/AA 
degree/Technical    school training
College graduate (BA or BS)
Masters degree
Doctorate/Medical degree/Law degree
8. What is your annual combined 
household income?
Less than $25,000
$25,000 – 50,000
$50,000 -100,000
$100,000 – 150,000
Greater than $150,000
9. Please indicate who you live with (you 
may check more than one box)
By myself
Partner/Spouse
Roommate/Friend
Children under 18
Children over 18
Group home/assisted living/nursing 
home
Parent
Other (please specify) _____________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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10. Current employment status
(please check all that apply): 
Employed (full-time or part-time)
Caring for home or family (not 
currently working and not looking for 
paid work)
Unemployed and looking for work
Unable to work due to illness or 
disability
Retired
Student
Other (please specify) _____________
11. Please indicate your relationship with 
the patient: 
Married or living as if married
Non-cohabitating relationship
Divorced/Separate
Friend
Family Member
Parent (mother or father)
Child (daughter or son)
Sibling (brother or sister)
Other relative
I work with the patient through 
community mental health 
Other: ____________
12. Do you live with the patient?
Yes
No
13. Please estimate the number of hours per 
week (on average) you provide direct care 
for the patient:
1-2 hours per week
2-5 hours per week
5-10 hours per week
10-15 hours per week
Over 15 hours per week 
14.  Aside from mental health professionals, 
is there a medical health professional you 
see most often (a primary care provider)?
Yes
No
14a. If yes, who is your primary care 
provider?
________________________________
14b.  When was your last visit to your 
primary care provider?
________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, IN THE 
PAST WEEK? Please read each item and circle one number in each row to indicate your 
answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or sleeping 
too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you are 
a failure or have let yourself or your family 
down
0
1
2
3
7. Trouble concentrating on things, such as 
reading the newspaper or watching tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the opposite – 
being so fidgety or restless that you have 
been moving around a lot more than usual
0
1
2
3
9. Thoughts that you would be better off dead
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
UCLA 3-ITEM LONELINESS SCALE
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
INSTRUCTIONS: Please read each item below and circle one number in each row to indicate 
how often each statement is descriptive of you.
1 indicates “I hardly ever feel this way”
2 indicates “I sometimes feel this way” 
3 indicates “I often feel this way”
Hardly 
ever
Some of 
the time
Often
1. How often do you feel that you lack companionship?
1
2
3
2. How often do you feel left out?
1
2
3
3. How often do you feel isolated from others?
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
Caregiver Activation Measure (CG-PAM 10)
Below are statements people sometimes make about caring for the health of someone else. Please indicate 
how much you agree or disagree with each statement as it applies to you personally as a caregiver.
Circle the answer that is most true for you today. If the statement does not apply, select N/A. 
1. When all is said and done, I am responsible for seeing 
that this person’s health is managed properly.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in this person’s health care is 
one of the most important factors in determining her/his 
health and ability to function.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I know what each of this person’s prescribed 
medications do.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I am confident that I can tell when this person needs to 
get medical care and when I can handle the problem 
myself.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident I can tell a doctor the concerns that I 
have about this person’s health even when he or she does 
not ask.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident that I can follow through on medical 
treatments I need to do for this person at home.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I am able to help this person maintain lifestyle 
changes (like eating right or exercising) for her/his 
condition.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I know how to prevent problems with this person’s 
health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I am confident I can figure out solutions when new 
situations or problems arise with this person’s health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I am confident I can help this person with lifestyle 
changes, like diet and exercise, even during times of 
stress.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Version 6.0, 3/26/2019
Caregiver Reaction Assessment
Circle the number corresponding to your answer
Questions:
Strongly 
disagree
Disagree
Neither 
agree nor 
disagree
Agree
Strongly 
agree
1.   I feel privileged to care for ___.
1
2
3
4
5
2.  Others have dumped caring for ___ onto me.
1
2
3
4
5
3.  My financial resources are adequate to pay for things
that are required for caregiving.
1
2
3
4
5
4.  My activities are centered around care for ___.
1
2
3
4
5
5.  Since caring for ___, it seems like I’m tired all of the
time. 
1
2
3
4
5
6.  It is very difficult to get help from my family in 
taking care of ___.
1
2
3
4
5
7.   I resent having to take care of ___.
1
2
3
4
5
8.   I have to stop in the middle of work.
1
2
3
4
5
9.   I really want to care for ___.
1
2
3
4
5
10. My health has gotten worse since I’ve been caring 
for ___.
1
2
3
4
5
11. I visit family and friends less since I have been 
caring for ___.
1
2
3
4
5
12.  I will never be able to do enough caregiving to 
repay ___.
1
2
3
4
5
13. My family works together at caring for ___.
1
2
3
4
5
14. I have eliminated things from my schedule since 
caring for ___.
1
2
3
4
5
15. I have enough physical strength to care for ___.
1
2
3
4
5
16. Since caring for ___, I feel my family has 
abandoned me.
1
2
3
4
5
17. Caring for ___ makes me feel good.
1
2
3
4
5
18. The constant interruptions make it difficult to find 
time for relaxation.
1
2
3
4
5
19. I am healthy enough to care for ___.
1
2
3
4
5
20. Caring for ___ is important to me.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Version 6.0, 3/26/2019
FAMCARE 2
21. Caring for ___ has put a financial strain on the 
family.
1
2
3
4
5
22. My family (brothers, sisters, children) left me alone 
to care for ___.
1
2
3
4
5
23. I enjoy caring for ___.
1
2
3
4
5
24. It's difficult to pay for ___'s health needs and 
services.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
Think about the care that the patient has received. Please answer the questions below indicating how 
satisfied you are with the care received: very satisfied (VS), satisfied (S), undecided (U), dissatisfied (D), 
or very dissatisfied (VD). Please circle the letters below that best match your experience. 
How satisfied are you with:
1. The patient’s comfort
VS
S
U
D
VD
2. The way in which the patient’s condition and likely progress 
have been explained by the team
VS
S
U
D
VD
3. Information given about the side effects of treatment
VS
S
U
D
VD
4. The way in which the team respects the patient’s dignity
VS
S
U
D
VD
5. Meetings with the team to discuss the patient’s condition 
and plan of care 
VS
S
U
D
VD
6. Speed with which symptoms are treated
VS
S
U
D
VD
7. The team’s attention to the patient’s description of 
symptoms
VS
S
U
D
VD
8. The way in which the patient’s needs for comfort are met
VS
S
U
D
VD
9. Availability of the team to the family
VS
S
U
D
VD
10. Emotional support provided to family members by the team
VS
S
U
D
VD
11. The practical assistance provided by the team (e.g. 
bathing, home care, respite)
VS
S
U
D
VD
12. The Doctor’s attention to the patient’s symptoms
VS
S
U
D
VD
13. The way the family is included in treatment and care 
decisions 
VS
S
U
D
VD
14. Information given about how to manage the patient’s 
symptoms (e.g. pain, constipation)
VS
S
U
D
VD
15. How effectively the team manages the patient’s symptoms 
VS
S
U
D
VD
16. The team’s response to changes in the patient’s care 
needs
VS
S
U
D
VD
17. Emotional support provided to the patient by the team
VS
S
U
D
VD
Pearlin Mastery Scale
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
Please circle the answer that best matches your experience.
1. There is really no way I can solve some of 
the problems that I have
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
2. Sometimes I feel that I’m being pushed 
around in life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
3. I have little control over the things that 
happen to me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
4. I can do just about anything I really set my 
mind to
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
5. I often feel helpless in dealing with the 
problems of life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
6. What happens to me in the future mostly 
depends on me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
7. There is little I can do to change many of 
the important things in my life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
PARTICIPANT LOCATOR FORM
Participant name: 
__________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Version 6.0, 3/26/2019
Home address: 
__________________________________________________
  
(Street)
    
(Apt.)
__________________________________________________
  
(City, State, Zip)
    
Preferred phone: 
__________________________________________________
Alternate phone: 
__________________________________________________
Email (will only be used if necessary):   ___________________________________
IN CASE WE HAVE TROUBLE REACHING YOU, PLEASE PROVIDE ONE OTHER PERSON WE 
COULD CONTACT (This is optional and will not affect your participation in the research study).
Contact name:     __________________________________________________
(Last)
    
 
(First)     
 (M.I.)
Relationship to participant:    ________________________________________
Preferred phone:    _________________________________________________
Alternate phone:    _________________________________________________
T. Caregiver 6-week Questionnaire
CAREGIVER ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 6 Weeks
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Version 6.0, 3/26/2019
 
Caregiver-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
CAREGIVER PATIENT ACTIVATION MEASURE (CG-PAM)
 
4
CAREGIVER REACTION ASSESSMENT
5
FAMCARE 2
6
PEARLIN MASTERY SCALE
Time Spent Caregiving
We understand that time spent caregiving may change over time. Think about the past two weeks. Please 
estimate the number of hours per week (on average) you provided direct care for the patient:
Less than 1 hour per week
1-2 hours per week
2-5 hours per week
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Version 6.0, 3/26/2019
5-10 hours per week
10-15 hours per week
Over 15 hours per week 
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, IN THE 
PAST WEEK? Please read each item and circle one number in each row to indicate your 
answer. 
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
233
Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
1. Little interest or pleasure in doing things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or sleeping 
too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you are 
a failure or have let yourself or your family 
down
0
1
2
3
7. Trouble concentrating on things, such as 
reading the newspaper or watching tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the opposite – 
being so fidgety or restless that you have 
been moving around a lot more than usual
0
1
2
3
9. Thoughts that you would be better off dead
0
1
2
3
GAD-7
Over the last 2 weeks, how often have you 
been bothered by the following problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Date__________
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2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
Caregiver Activation Measure (CG-PAM 10)
Below are statements people sometimes make about caring for the health of someone else. Please indicate 
how much you agree or disagree with each statement as it applies to you personally as a caregiver.
Circle the answer that is most true for you today. If the statement does not apply, select N/A. 
1. When all is said and done, I am responsible for seeing 
that this person’s health is managed properly.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in this person’s health care is 
one of the most important factors in determining her/his 
health and ability to function.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I know what each of this person’s prescribed 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Date__________
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medications do.
4. I am confident that I can tell when this person needs to 
get medical care and when I can handle the problem 
myself.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident I can tell a doctor the concerns that I 
have about this person’s health even when he or she does 
not ask.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident that I can follow through on medical 
treatments I need to do for this person at home.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I am able to help this person maintain lifestyle 
changes (like eating right or exercising) for her/his 
condition.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I know how to prevent problems with this person’s 
health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I am confident I can figure out solutions when new 
situations or problems arise with this person’s health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I am confident I can help this person with lifestyle 
changes, like diet and exercise, even during times of 
stress.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Caregiver Reaction Assessment
Circle the number corresponding to your answer
Questions:
Strongly 
disagree
Disagree
Neither 
agree nor 
disagree
Agree
Strongly 
agree
1.   I feel privileged to care for ___.
1
2
3
4
5
2.  Others have dumped caring for ___ onto me.
1
2
3
4
5
3.  My financial resources are adequate to pay for things
that are required for caregiving.
1
2
3
4
5
4.  My activities are centered around care for ___.
1
2
3
4
5
5.  Since caring for ___, it seems like I’m tired all of the
time. 
1
2
3
4
5
6.  It is very difficult to get help from my family in 
taking care of ___.
1
2
3
4
5
7.   I resent having to take care of ___.
1
2
3
4
5
8.   I have to stop in the middle of work.
1
2
3
4
5
9
I really want to care for
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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FAMCARE 2
21. Caring for ___ has put a financial strain on the 
family.
1
2
3
4
5
22. My family (brothers, sisters, children) left me alone 
to care for ___.
1
2
3
4
5
23. I enjoy caring for ___.
1
2
3
4
5
24. It's difficult to pay for ___'s health needs and 
services.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Version 6.0, 3/26/2019
Think about the care that the patient has received. Please answer the questions below indicating how 
satisfied you are with the care received: very satisfied (VS), satisfied (S), undecided (U), dissatisfied (D), 
or very dissatisfied (VD). Please circle the letters below that best match your experience. 
How satisfied are you with:
1. The patient’s comfort
VS
S
U
D
VD
2. The way in which the patient’s condition and likely progress 
have been explained by the team
VS
S
U
D
VD
3. Information given about the side effects of treatment
VS
S
U
D
VD
4. The way in which the team respects the patient’s dignity
VS
S
U
D
VD
5. Meetings with the team to discuss the patient’s condition 
and plan of care 
VS
S
U
D
VD
6. Speed with which symptoms are treated
VS
S
U
D
VD
7. The team’s attention to the patient’s description of 
symptoms
VS
S
U
D
VD
8. The way in which the patient’s needs for comfort are met
VS
S
U
D
VD
9. Availability of the team to the family
VS
S
U
D
VD
10. Emotional support provided to family members by the team
VS
S
U
D
VD
11. The practical assistance provided by the team (e.g. 
bathing, home care, respite)
VS
S
U
D
VD
12. The Doctor’s attention to the patient’s symptoms
VS
S
U
D
VD
13. The way the family is included in treatment and care 
decisions 
VS
S
U
D
VD
14. Information given about how to manage the patient’s 
symptoms (e.g. pain, constipation)
VS
S
U
D
VD
15. How effectively the team manages the patient’s symptoms 
VS
S
U
D
VD
16. The team’s response to changes in the patient’s care 
needs
VS
S
U
D
VD
17. Emotional support provided to the patient by the team
VS
S
U
D
VD
Pearlin Mastery Scale
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Please circle the answer that best matches your experience.
1. There is really no way I can solve some of 
the problems that I have
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
2. Sometimes I feel that I’m being pushed 
around in life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
3. I have little control over the things that 
happen to me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
4. I can do just about anything I really set my 
mind to
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
5. I often feel helpless in dealing with the 
problems of life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
6. What happens to me in the future mostly 
depends on me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
7. There is little I can do to change many of 
the important things in my life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
U. Caregiver 12-Week Questionnaire 
CAREGIVER ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Time point: 12 Weeks
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Caregiver-Reported Measures 
Date
1
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
 
2
GENERALIZED ANXIETY DISORDER 7-ITEM SCALE (GAD-7)
 
3
UCLA 3-ITEM LONELINESS SCALE
4
CAREGIVER PATIENT ACTIVATION MEASURE (CG-PAM)
 
5
CAREGIVER REACTION ASSESSMENT
6
FAMCARE 2
7
PEARLIN MASTERY SCALE 
Time Spent Caregiving
We understand that time spent caregiving may change over time. Think about the past two weeks. Please 
estimate the number of hours per week (on average) you provided direct care for the patient:
Less than 1 hour per week
1-2 hours per week
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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2-5 hours per week
5-10 hours per week
10-15 hours per week
Over 15 hours per week 
PHQ-9
INSTRUCTIONS: How often have you been bothered by any of the following problems, IN THE 
PAST WEEK? Please read each item and circle one number in each row to indicate your 
answer. 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Version 6.0, 3/26/2019
Not 
at all
Several 
days
More 
than 
half 
the days
Nearly 
every 
day
1. Little interest or pleasure in doing things
0
1
2
3
2. Feeling down, depressed, or hopeless
0
1
2
3
3. Trouble falling or staying asleep, or sleeping 
too much
0
1
2
3
4. Feeling tired or having little energy
0
1
2
3
5. Poor appetite or overeating
0
1
2
3
6. Feeling bad about yourself - or that you are 
a failure or have let yourself or your family 
down
0
1
2
3
7. Trouble concentrating on things, such as 
reading the newspaper or watching tv
0
1
2
3
8. Moving or speaking so slowly that other 
people could have noticed. Or the opposite – 
being so fidgety or restless that you have 
been moving around a lot more than usual
0
1
2
3
9. Thoughts that you would be better off dead
0
1
2
3
GAD-7
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
242
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Version 6.0, 3/26/2019
Over the last 2 weeks, how often have you 
been bothered by the following problems?
Not at all
Several 
days
More than 
half the 
days
Nearly 
every day
1. Feeling nervous, anxious or on edge
0
1
2
3
2. Not being able to stop or control worrying
0
1
2
3
3. Worrying too much about different things
0
1
2
3
4. Trouble relaxing
0
1
2
3
5. Being so restless that it is hard to sit still
0
1
2
3
6. Becoming easily annoyed or irritable
0
1
2
3
7. Feeling afraid as if something awful might 
happen
0
1
2
3
UCLA 3-ITEM LONELINESS SCALE
INSTRUCTIONS: Please read each item below and circle one number in each row to indicate 
how often each statement is descriptive of you.
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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1 indicates “I hardly ever feel this way”
2 indicates “I sometimes feel this way” 
3 indicates “I often feel this way”
Hardly 
ever
Some of 
the time
Often
1. How often do you feel that you lack companionship?
1
2
3
2. How often do you feel left out?
1
2
3
3. How often do you feel isolated from others?
1
2
3
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
244
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Version 6.0, 3/26/2019
Caregiver Activation Measure (CG-PAM 10)
Below are statements people sometimes make about caring for the health of someone else. Please indicate 
how much you agree or disagree with each statement as it applies to you personally as a caregiver.
Circle the answer that is most true for you today. If the statement does not apply, select N/A. 
1. When all is said and done, I am responsible for seeing 
that this person’s health is managed properly.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
2. Taking an active role in this person’s health care is 
one of the most important factors in determining her/his 
health and ability to function.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
3. I know what each of this person’s prescribed 
medications do.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
4. I am confident that I can tell when this person needs to 
get medical care and when I can handle the problem 
myself.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
5. I am confident I can tell a doctor the concerns that I 
have about this person’s health even when he or she does 
not ask.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
6. I am confident that I can follow through on medical 
treatments I need to do for this person at home.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
7. I am able to help this person maintain lifestyle 
changes (like eating right or exercising) for her/his 
condition.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
8. I know how to prevent problems with this person’s 
health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
9. I am confident I can figure out solutions when new 
situations or problems arise with this person’s health. 
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
10. I am confident I can help this person with lifestyle 
changes, like diet and exercise, even during times of 
stress.
Disagree      Disagree    Agree      Agree        N/A
Strongly                                       Strongly  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
245
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Version 6.0, 3/26/2019
Caregiver Reaction Assessment
Circle the number corresponding to your answer
Questions:
Strongly 
disagree
Disagree
Neither 
agree nor 
disagree
Agree
Strongly 
agree
1.   I feel privileged to care for ___.
1
2
3
4
5
2.  Others have dumped caring for ___ onto me.
1
2
3
4
5
3.  My financial resources are adequate to pay for things
that are required for caregiving.
1
2
3
4
5
4.  My activities are centered around care for ___.
1
2
3
4
5
5.  Since caring for ___, it seems like I’m tired all of the
time. 
1
2
3
4
5
6.  It is very difficult to get help from my family in 
taking care of ___.
1
2
3
4
5
7.   I resent having to take care of ___.
1
2
3
4
5
8.   I have to stop in the middle of work.
1
2
3
4
5
9.   I really want to care for ___.
1
2
3
4
5
10. My health has gotten worse since I’ve been caring 
for ___.
1
2
3
4
5
11. I visit family and friends less since I have been 
caring for ___.
1
2
3
4
5
12.  I will never be able to do enough caregiving to 
repay ___.
1
2
3
4
5
13. My family works together at caring for ___.
1
2
3
4
5
14. I have eliminated things from my schedule since 
caring for ___.
1
2
3
4
5
15. I have enough physical strength to care for ___.
1
2
3
4
5
16. Since caring for ___, I feel my family has 
abandoned me.
1
2
3
4
5
17. Caring for ___ makes me feel good.
1
2
3
4
5
18. The constant interruptions make it difficult to find 
time for relaxation.
1
2
3
4
5
19. I am healthy enough to care for ___.
1
2
3
4
5
20. Caring for ___ is important to me.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
246
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Version 6.0, 3/26/2019
FAMCARE 2
21. Caring for ___ has put a financial strain on the 
family.
1
2
3
4
5
22. My family (brothers, sisters, children) left me alone 
to care for ___.
1
2
3
4
5
23. I enjoy caring for ___.
1
2
3
4
5
24. It's difficult to pay for ___'s health needs and 
services.
1
2
3
4
5
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
247
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Version 6.0, 3/26/2019
Think about the care that the patient has received. Please answer the questions below indicating how 
satisfied you are with the care received: very satisfied (VS), satisfied (S), undecided (U), dissatisfied (D), 
or very dissatisfied (VD). Please circle the letters below that best match your experience. 
How satisfied are you with:
1. The patient’s comfort
VS
S
U
D
VD
2. The way in which the patient’s condition and likely progress 
have been explained by the team
VS
S
U
D
VD
3. Information given about the side effects of treatment
VS
S
U
D
VD
4. The way in which the team respects the patient’s dignity
VS
S
U
D
VD
5. Meetings with the team to discuss the patient’s condition 
and plan of care 
VS
S
U
D
VD
6. Speed with which symptoms are treated
VS
S
U
D
VD
7. The team’s attention to the patient’s description of 
symptoms
VS
S
U
D
VD
8. The way in which the patient’s needs for comfort are met
VS
S
U
D
VD
9. Availability of the team to the family
VS
S
U
D
VD
10. Emotional support provided to family members by the team
VS
S
U
D
VD
11. The practical assistance provided by the team (e.g. 
bathing, home care, respite)
VS
S
U
D
VD
12. The Doctor’s attention to the patient’s symptoms
VS
S
U
D
VD
13. The way the family is included in treatment and care 
decisions 
VS
S
U
D
VD
14. Information given about how to manage the patient’s 
symptoms (e.g. pain, constipation)
VS
S
U
D
VD
15. How effectively the team manages the patient’s symptoms 
VS
S
U
D
VD
16. The team’s response to changes in the patient’s care 
needs
VS
S
U
D
VD
17. Emotional support provided to the patient by the team
VS
S
U
D
VD
Pearlin Mastery Scale
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
248
Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
Please circle the answer that best matches your experience.
1. There is really no way I can solve some of 
the problems that I have
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
2. Sometimes I feel that I’m being pushed 
around in life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
3. I have little control over the things that 
happen to me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
4. I can do just about anything I really set my 
mind to
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
5. I often feel helpless in dealing with the 
problems of life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
6. What happens to me in the future mostly 
depends on me
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
7. There is little I can do to change many of 
the important things in my life
Strongly         Disagree       Agree        Strongly 
Disagree                                                   Agree
V. Caregiver 12-week Exit Survey (Bridge arm only)
CAREGIVER - 12-WEEK PARTICIPANT FEEDBACK
We are now interested to know about your satisfaction with different aspects of this intervention. There are no right 
or wrong answers. Your answers will be kept confidential and will not affect your participation in future research 
studies, or your access to care at MGH or affiliated sites. As a reminder, you participated as a caregiver in a 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
249
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Version 6.0, 3/26/2019
research study of an intervention that involved a psychiatrist (Dr. Irwin or Dr. Marouf) and a social work 
case manager (Amy Corveleyn) in the patient’s cancer care team. 
1.
From your perspective, how useful was the intervention in the patient’s cancer care?   
Very useful                Somewhat useful                A little bit useful                    Not at all useful 
2.    How useful was the intervention for you as a caregiver? 
Very useful                Somewhat useful                A little bit useful                    Not at all useful
3.  How useful were the following parts of the intervention? 
4. What do you think was the most useful part about the intervention in the patient’s cancer care? 
___________________________________________________________________________________________
_____________________________________________________________________________
5. What do you think was the most useful part about the intervention for you as a caregiver?
___________________________________________________________________________________________
_____________________________________________________________________________
6. What changes, if any, did you notice in your relationship with the patient because of the intervention? 
___________________________________________________________________________________________
_____________________________________________________________________________
7. What do you think could be improved about the intervention? 
___________________________________________________________________________________________
_____________________________________________________________________________
8. What else, if anything, would you like to add about the intervention that we did not discuss? 
____________________________________________________________________________________
Thank you for being a part of the Proactive Psychiatry Consultation for Patients with Cancer Study. Your feedback 
is valuable to us and we appreciate your responses.
Involving psychiatry early in the patient’s cancer care 
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful 
Don’t know/ Does 
not apply to me
Meeting with the psychiatrist (Dr. Irwin/Dr. Marouf) in 
person
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Being able to reach the psychiatrist (Dr. Irwin/Dr. 
Marouf) by phone or email
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Being able to reach the case manager, Amy, by phone 
or email
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Communicating with the patient’s community mental 
health clinicians 
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Meeting with the patient’s cancer and psychiatry teams 
together
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Helping with barriers to the patient’s care (e.g. rides to 
the hospital, insurance, housing)
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Addressing the patient’s psychiatric symptoms and 
medications 
Very useful
Somewhat 
useful
A little bit 
useful
Not at all 
useful
Don’t know/ Does 
not apply to me
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
250
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Version 6.0, 3/26/2019
W. Clinician-Administered Assessments
ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Timepoints: Baseline
Clinician-Administered Measures
Date
1
BRIEF PSYCHIATRIC RATING SCALE (BPRS)
2
CLINICAL GLOBAL IMPRESSION – SEVERITY (CGI-S)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
251
Proactive Psychiatry Consultation for Patients with Serious Mental Illness and Cancer
Version 6.0, 3/26/2019
BRIEF PSYCHIATRIC RATING SCALE (BPRS)
Please enter the score for the term that best describes the patient’s condition
0 = Not assessed,  1 = Not present,  2 = Very mild,  3 = Mild,  4 = Moderate, 
5 = Moderately severe,  6 = Severe,  7 = Extremely severe 
Score
Condition
1. SOMATIC CONCERN 
2. ANXIETY 
3. DEPRESSION 
4. SUICIDALITY 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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5. GUILT 
6. HOSTILITY 
7. ELEVATED MOOD 
8. GRANDIOSITY 
9. SUSPICIOUSNESS 
10. HALLUCINATIONS 
11. UNUSUAL THOUGHT CONTENT
12. BIZARRE BEHAVIOR
13. SELF-NEGLECT 
14. DISORIENTATION
15. CONCEPTUAL DISORGANIZATION 
16. BLUNTED AFFECT 
17. EMOTIONAL WITHDRAWAL
18. MOTOR RETARDATION
19. TENSION
20. UNCOOPERATIVENESS
21. EXCITEMENT
22. DISTRACTABILITY 
23. MOTOR HYPERACTIVITY
24. MANNERISMS AND POSTURING
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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CGI -SEVERITY OF ILLNESS
1. Considering your total clinical experience with this particular population, how mentally 
ill is the patient at this time? 
□ Not Assessed (0)
□ Normal, not at all ill (1)
□ Borderline mentally ill (2)
□ Mildly ill (3)
□ Moderately ill (4)
□ Markedly ill (5)
□ Severely ill (6)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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□ Among the most extremely ill patients (7)
ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Timepoint: 6-week
Clinician-Administered Measures
Date
1
CLINICAL GLOBAL IMPRESSION – SEVERITY (CGI-S)
2
CLINICAL GLOBAL IMPRESSION – IMPROVEMENT (CGI-I)
*NOTE: BRIDGE ARM ONLY*
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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CGI -SEVERITY OF ILLNESS
1. Considering your total clinical experience with this particular population, how mentally 
ill is the patient at this time? 
□ Not Assessed (0)
□ Normal, not at all ill (1)
□ Borderline mentally ill (2)
□ Mildly ill (3)
□ Moderately ill (4)
□ Markedly ill (5)
□ Severely ill (6)
□ Among the most extremely ill patients (7)
CGI - IMPROVEMENT OF ILLNESS
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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1. Compared to the patient’s condition at admission to the project, this patient’s condition 
is: 
Very much improved since the initiation of treatment (1)
Much improved (2)
Minimally improved (3)
No change from baseline (the initiation of treatment) (4)
Minimally worse (5)
Much worse (6)
Very much worse since the initiation of treatment (7)
ASSESSMENT CHECKLIST
Date: _________
Study ID: ______
Timepoint: 12-week and 24-week
Clinician-Administered Measures
Date
1
BRIEF PSYCHIATRIC RATING SCALE (BPRS)
2
CLINICAL GLOBAL IMPRESSION – SEVERITY (CGI-S)
3
CLINICAL GLOBAL IMPRESSION – IMPROVEMENT (CGI-I)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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BRIEF PSYCHIATRIC RATING SCALE (BPRS)
Please enter the score for the term that best describes the patient’s condition
0 = Not assessed,  1 = Not present,  2 = Very mild,  3 = Mild,  4 = Moderate, 
5 = Moderately severe,  6 = Severe,  7 = Extremely severe 
Score
Condition
1. SOMATIC CONCERN 
2. ANXIETY 
3. DEPRESSION 
4. SUICIDALITY 
5. GUILT 
6. HOSTILITY 
7. ELEVATED MOOD 
8. GRANDIOSITY 
9. SUSPICIOUSNESS 
10. HALLUCINATIONS 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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11. UNUSUAL THOUGHT CONTENT
12. BIZARRE BEHAVIOR
13. SELF-NEGLECT 
14. DISORIENTATION
15. CONCEPTUAL DISORGANIZATION 
16. BLUNTED AFFECT 
17. EMOTIONAL WITHDRAWAL
18. MOTOR RETARDATION
19. TENSION
20. UNCOOPERATIVENESS
21. EXCITEMENT
22. DISTRACTABILITY 
23. MOTOR HYPERACTIVITY
24. MANNERISMS AND POSTURING
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
259
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Version 6.0, 3/26/2019
CGI -SEVERITY OF ILLNESS
1. Considering your total clinical experience with this particular population, how mentally 
ill is the patient at this time? 
□ Not Assessed (0)
□ Normal, not at all ill (1)
□ Borderline mentally ill (2)
□ Mildly ill (3)
□ Moderately ill (4)
□ Markedly ill (5)
□ Severely ill (6)
□ Among the most extremely ill patients (7)
CGI - IMPROVEMENT OF ILLNESS
1. Compared to the patient’s condition at admission to the project, this patient’s condition 
is: 
Very much improved since the initiation of treatment (1)
Much improved (2)
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Minimally improved (3)
No change from baseline (the initiation of treatment) (4)
Minimally worse (5)
Much worse (6)
Very much worse since the initiation of treatment (7)
X. Oncology and Mental Health Clinician Email Consent
Proactive Psychiatry Consultation and Case Management for Patients with Cancer
Dear [Clinician Name],
I am emailing about one of your patients who recently completed participation in Dr. Kelly Irwin’s 
randomized controlled trial of proactive psychiatry consultation and case management for patients with 
serious mental illness. We would love (your feedback on how useful the intervention has been for your 
patient and for you, as a clinician) / (to learn about your experience caring for this patient during their 
cancer treatment).
Can I schedule a 5-10 minute call at a time that is convenient for you? If preferred, you can 
complete the survey via email or in-person.  
Your responses may be used for research purposes.  All data will be kept confidential and accessible only 
to study staff.  Responses will be aggregated and de-identified prior to publication. 
Completion of the brief survey will count as your consent to participate in the study.  Please feel free to 
contact the PI, Dr. Kelly Irwin, with any questions or concerns.  
Thank you for your time,
[Study Staff]
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
261
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Y. Oncology Clinician Exit Survey (EUC)
Oncology Clinician Exit Survey 
Proactive Psychiatry Consultation for Patients with Cancer Study 
We are currently conducting a research study of an intervention involving proactive psychiatry 
consultation and a social work case manager for patients with serious mental illness and a recent cancer 
diagnosis. Your patient, XXXXXX XXXXX, participated in this study. We would like to learn about your 
experience caring for this patient during their cancer treatment. You will not be compensated for 
participating in this study. 
There are minimal risks involved with providing this feedback. However, it is possible that providing 
feedback may make you feel uncomfortable. The benefits of your participation are that researchers may 
better understand the challenges and benefits of this intervention for patients with serious mental illness 
and cancer. Your participation is voluntary and your responses will be kept confidential. We will not 
collect your name or other identifying information. With your permission, we will record your responses 
for our data analysis. You can withdraw from the study, stop the survey, or choose not to answer any 
questions. Neither your feedback nor your decision to participate will affect your employment or care at 
Massachusetts General Hospital.  If you have questions about the study, you may contact Dr. Kelly Irwin 
at 617-643-4453 or kirwin1@partners.org. 
Thank you very much for your time!
1. What year did you graduate from oncology fellowship/start work as an oncology NP? ______
2. Gender: ___________
3. How many patients have you cared for with cancer and serious mental illness (such as schizophrenia, 
bipolar disorder, or severe major depression) since graduating from fellowship/completing training?
1
2-5
5-10
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
262
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Version 6.0, 3/26/2019
10-20
20-50
More than 50
The following questions are specifically about your experience caring for your pt XXXX who 
participated in the study.
4. Has he/she completed the recommended cancer treatment? Please check all that apply:
Surgery
Chemotherapy
Radiation 
Endocrine therapy
Targeted therapy
Other:___________________
Notes:________________________________________________________________________
_____________________________________________________________________________
Note: The study team will tailor this question to each clinician completing the exit survey based on their 
involvement in the cancer care of this patient.
Considering the cancer treatment that could have been completed up until this point (from date of 
enrollment to 24 weeks), how much of the recommended cancer treatment has been completed?
All
Most
Some
A little bit
None
Please approximate the percentage: _____________
5. Did this patient have a clinically significant disruption in cancer care at any of the following 
timepoints?
By disruption we mean: A delay to the initiation of treatment, a change from guideline-concordant 
treatment at the time of cancer diagnosis, or interruption in cancer treatment received?
Prior to enrollment in the trial (insert the patient’s date of enrollment)?
Yes
No
While enrolled in the trial (insert the patient’s enrollment date – 24-week completion date)?
Yes
No
After completion of the trial (insert the patient’s 24-week completion date)?
Yes
No
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
263
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a.
If yes, did this patient have a delay, change, or interruption in their cancer treatment? Please 
check all that apply:
Delay
Change
Interruption
From your perspective, what were the reasons for this delay?
___________________________________________________________________________
In particular, do you think that mental illness contributed to this delay?
Yes
No
If yes, how? 
____________________________________________________________________
From your perspective, what were the reasons for this change?
___________________________________________________________________________
In particular, do you think that mental illness contributed to this change?
Yes
No
If yes, how? 
____________________________________________________________________
From your perspective, what were the reasons for this interruption?
___________________________________________________________________________
In particular, do you think that mental illness contributed to this interruption?
Yes
No
If yes, how? 
___________________________________________________________________________
6.  Reflecting on everything that you have shared, do you think this patient received the same regimen 
and intensity of cancer treatment as other patients who present with the same stage of disease? 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Yes
No
If not, how was the treatment different? 
_______________________________________________
Why was the treatment different? 
___________________________________________________________________________
7. What else, if anything, would you like to add about the patient’s treatment that we did not discuss? 
_____________________________________________________________________________________
_______________________________________________________________________
8. Are there any other concerns about this patient’s treatment or treatment potential?
______________________________________________________________________________
____________________________________________________________________________
Z. Oncology Clinician Exit Survey Bridge
Proactive Psychiatry Consultation for Patients with Cancer Study 
ONCOLOGY CLINICIANS
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
265
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Version 6.0, 3/26/2019
We are currently conducting a research study of an intervention involving proactive psychiatry 
consultation and a social work case manager for patients with serious mental illness and a recent cancer 
diagnosis. Your patient, XXXXXX XXXXX, participated in this intervention. We would like your 
feedback on the challenges and benefits of this intervention and how it can be most useful to you as an 
oncology clinician. You will not be compensated for participating in this study. 
There are minimal risks involved with providing this feedback. However, it is possible that providing 
feedback may make you feel uncomfortable. The benefits of your participation are that researchers may 
better understand the challenges and benefits of this intervention for patients with serious mental illness 
and cancer. Your participation is voluntary and your responses will be kept confidential. We will not 
collect your name or other identifying information. With your permission, we will record your responses 
for our data analysis. You can withdraw from the study, stop the survey, or choose not to answer any 
questions. Neither your feedback nor your decision to participate will affect your employment or care at 
Massachusetts General Hospital.  If you have questions about the study, you may contact Dr. Kelly Irwin 
at 617-643-4453 or kirwin1@partners.org. 
Thank you very much for your time!
  
1. What year did you graduate from oncology fellowship/start work as an oncology NP?  _________
2. Gender: ______________
3. How many patients have you cared for with cancer and serious mental illness (such as schizophrenia, 
bipolar disorder, or severe major depression) since graduating from fellowship/completing training?
1
2-5
5-10
10-20
20-50
More than 50
The following questions are specifically about your experience caring for your pt XXXX who 
participated in the intervention.
4. How useful was the intervention in the patient’s cancer care? 
Very useful                Somewhat useful                A little bit useful            Not at all useful
What was most useful?
__________________________________________________________________________________
____________________________________________________________________
What would you change to improve the intervention? 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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__________________________________________________________________________________
____________________________________________________________________
5. Did you find the joint visit to be useful?
Very useful              Somewhat useful              A little bit useful          Not at all useful
Please explain.
__________________________________________________________________________________
____________________________________________________________________
6. Has he/she completed their recommended cancer treatment? Please check all that apply:
Surgery
Chemotherapy
Radiation 
Endocrine therapy
Targeted therapy
Other:___________________
Notes:________________________________________________________________________
_____________________________________________________________________________
Note: The study team will tailor this question to each clinician completing the exit survey based on their 
involvement in the cancer care of this patient.
Considering the cancer treatment that could have been completed up until this point (from date of 
enrollment to 24 weeks), how much of the recommended cancer treatment has been completed?
All
Most
Some
A little bit
None
Please approximate the percentage: _________________________
7. Did this patient have a clinically significant disruption in cancer care at any of the following 
timepoints?
By disruption we mean: A delay to the initiation of treatment, a change from guideline-concordant 
treatment at the time of cancer diagnosis, or interruption in cancer treatment received?
Prior to enrollment in the trial (insert the patient’s date of enrollment)?
Yes
No
While enrolled in the trial (insert the patient’s enrollment date – 24-week completion date)?
Yes
No
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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After completion of the trial (insert the patient’s 24-week completion date)?
Yes
No
a.
 If yes, did this patient have a delay, change, or interruption in their cancer treatment? Please 
check all that apply:
Delay
Change
Interruption
From your perspective, what were the reasons for this delay?
________________________________________________________________________
In particular, do you think that mental illness contributed to this delay?
Yes
No
If yes, how? 
_____________________________________________________________________
From your perspective, what were the reasons for this change?
_______________________________________________________________________
In particular, do you think that mental illness contributed to this change?
Yes
No
If yes, how? 
_______________________________________________________________________
From your perspective, what were the reasons for this interruption?
_______________________________________________________________________
In particular, do you think that mental illness contributed to this interruption?
Yes
No
If yes, how?
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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_____________________________________________________________________
8. What impact did the intervention have on the cancer care for your patient? 
Large positive 
Small positive
No impact
Small negative
Large negative
impact
     impact
      impact
        impact
a) Did the intervention impact the cancer treatment plan? 
Yes
No
If yes, how so? 
_________________________________________________________________________
b) Did the intervention impact your relationship with this patient? 
Yes
No 
If yes, how so? 
__________________________________________________________________________
c) Did the intervention impact your communication with the patient or caregiver?
Yes
No 
If yes, how so? 
__________________________________________________________________________
9.  Did the intervention help you as the oncologist care for the patient? 
Yes 
No
      If yes, how so? 
__________________________________________________________________________
10.  Reflecting on everything that you have shared, do you think this patient received the same regimen 
and intensity of cancer treatment as other patients who present with the same stage of disease? 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Yes
No
If not, how was the treatment different? 
___________________________________________________________________________
Why was the treatment different?
___________________________________________________________________________
11. What else, if anything, would you like to add about the intervention that we have not discussed?
______________________________________________________________________________
______________________________________________________________________________
12. Are there any other concerns about this patient’s treatment or treatment potential?
______________________________________________________________________________
AA. Mental Health Clinician Exit Survey
Proactive Psychiatry Consultation for Patients with Cancer Study 
MENTAL HEALTH CLINICIANS
We are completing a research study of a care delivery model intervention for patients with serious mental 
illness and a recent cancer diagnosis which includes a psychiatry consultation and access to a social work 
case manager. Your patient, XXXXXX XXXXX, participated in this study. We would like your feedback 
on the challenges and benefits of this intervention, and ideas on how this intervention can be most useful 
to you. We estimate that participation will take 5-10 minutes. You will not be compensated for 
participating in this study. 
There are minimal risks involved with providing feedback. However, it is possible that providing 
feedback may make you feel uncomfortable. The benefits of your participation are that researchers may 
better understand the challenges and benefits of psychiatry and social work interventions for patients with 
serious mental illness who have been recently diagnosed with cancer. Your participation is voluntary and 
your responses will be kept confidential. We will not collect your name or other identifying information 
about you. With your permission, we will record your responses for our data analysis. You can stop 
participating, choose not to answer any of the questions, or withdraw from the study at any time.  Neither 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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your feedback nor your decision to participate will affect your care or your patient’s care at Massachusetts 
General Hospital.  If you have questions about the study, you may contact Dr. Kelly Irwin at 617-643-
4453 or kirwin1@partners.org. 
Thank you very much for your time!
1. Please select your clinical discipline: 
 
Licensed Mental Health Clinician
Social Work
Psychology 
Psychiatry
Psychiatric Nurse Practitioner
Primary Care Provider
Other: ____________________
2. What year did you receive your license/start practicing independently? _________
3. Gender: _____________ 
4. How often do you see this patient? ____________________________________________
5. Where do you see patients clinically? Please check all that apply. 
A private office
Community mental health clinic 
Academic hospital
Other: ________________
6. Of the patients you currently care for, how many have cancer and bipolar disorder? 
Approximate # ___________
7. Of the patients you currently care for, how many have cancer and schizophrenia? 
Approximate # ___________
8. Of the patients you currently care for, how many have cancer and severe major depression (with prior 
psychiatric hospitalization or suicide attempt)? 
Approximate # ___________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
271
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Version 6.0, 3/26/2019
The following questions are specifically about your experience caring for your pt XXXX, who 
participated in the 12-week intervention which combined proactive psychiatry consultation and 
case management for patients with serious mental illness and cancer.
9. In your opinion, how useful was the intervention in the patient’s cancer care? 
Very useful                Somewhat useful                A little bit useful            Not at all useful
What do you think was most useful?
__________________________________________________________________________________
____________________________________________________________________
What would you change to improve the intervention? 
__________________________________________________________________________________
____________________________________________________________________
10. How did the intervention impact the coordination of cancer and mental health care?
_____________________________________________________________________________________
_______________________________________________________________________
11. How did the intervention impact your communication with the oncology team?
______________________________________________________________________________
______________________________________________________________________________
12. What worked best to communicate with you? Please check all that apply.
Phone            
Email
Text 
   
13. Have you seen XXXX since they started the intervention? 
Yes
No
If not, why? 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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_____________________________________________________________________________________
_______________________________________________________________________
14. What information, assistance or support would be helpful to you now that your patient completed the 
intervention? 
_____________________________________________________________________________________
_______________________________________________________________________
15. What else, if anything, would you like to add that we have not discussed?
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_________________________________________________________
Thank you for your participation in the study and for offering your feedback!
 
BB. Caregiver Risk Assessment Semi-Structured Guide
Family Version
Date of Assessment:
Caregiver Name:
Patient’s Name:
Contact information: (phone/email/text) 
Best way to contact:
Relationship to patient:
Time spent with patient per week/month:
Where does the patient live? Do you live with the patient? Will that be consistent through treatment?:
Are you and/or the patient at risk for losing your housing?:
Is there someone you share caregiving responsibilities with? What is the best way to contact this person?:
Is there a health care proxy?:
Is there a court appointed guardian? What is the best way to contact this person?:
Who manages the patient’s medications?:
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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What are your worries about the patient receiving treatment? How will the patient get to treatment?:
Do you have concerns about the patient’s income/finances?:
Do you have any safety concerns for the patient?:
Patient Strengths:
Stressors/Barriers to caregiving:
Medical illness: Do you see a PCP? What other providers do you see? What for? What medications do you take?:
Mental illness: Do you see a mental health professional? What for?: 
Are you concerned about being able to pay your monthly bills during this time?:
What are your worries about your own needs? Where do you receive support?:
What is your understanding of the patient’s illness and treatment plan?:
What questions do you have for the oncology team?:
Resource needs:
Plan:
Impression:
Community Version
Date of Assessment:
Caregiver’s Name:
Patient’s Name:
Contact information: (phone/email/text) 
Best way to contact:
Relationship to patient:
Time spent with patient per week/month:
Who covers you with this patient when you are out of the office? What is the best way to contact this person?:
How does caregiving fit with your current role?
Is there a health care proxy?:
Is there a court appointed guardian? What is the best way to contact this person?:
Who manages the patient’s medications?:
What are your worries about the patient receiving treatment? How will the patient get to treatment?:
Where does the patient live? Will that be consistent through treatment?:
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Do you have concerns about the patient’s income/finances?:
Do you have any safety concerns for the patient?:
Patient Strengths:
Stressors/Barriers to caregiving:
What are your worries about your own needs? Where do you receive support?:
What is your understanding of the patient’s illness and treatment plan?:
What questions do you have for the oncology team?:
Resource needs:
Plan:
Impression:
CC. Patient Initial Assessment Semi-Structured Guide 
BRIDGE INITIAL ASSESSMENT: COLLABORATIVE CARE FOR MENTAL ILLNESS AND CANCER
Assessment date: 
Best way to reach participant: 
Oncology team: 
Community mental health team: 
PCP:
Collaborative Care team at MGH: Dr. Kelly Irwin, Amy Corveleyn LICSW
 Caregiver: include if consented/not consented
ID/Reason for Referral (Summary):
Chief Complaint (participant’s own words): 
History of Present Illness: 
Illness understanding: 
Motivation for cancer treatment: 
Cancer treatment goals (what do they hope treatment will achieve):
Potential barriers:
Strengths: 
Past Psychiatric History:
Past Oncology History:
Additional Past Medical and Surgical History:
Social History:
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

Subject ID_____
Date__________
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Substance Use Hx: 
Family Hx: 
 
Spiritual Hx: 
Data: 
ROS:
PE:
Mental Status Exam:
Impression:
Recommendations:
DD. Psychosocial Resources Flyer
Mental Health Resources and Supportive Services
Psychiatric Oncology
Phone: 617-643-6833
Psychiatrists specializing in the care of oncology patients provide treatment for anxiety, depression and 
coping with persistent physical symptoms or emotional challenges surrounding cancer treatment.
Maxwell V. Blum Cancer Resource Program
The Maxwell V. Blum Cancer Resource Program offers a range of support resources around the Cancer 
Center. The program has an ongoing mission to make support services, as well as respite and 
community-building areas, more accessible to patients and families throughout the Cancer Center. 
Phone: 617-724-1822
The Katherine A. Gallagher Integrative Therapies Program
The Katherine A. Gallagher Integrative Therapies Program offers free wellness services, such as 
acupuncture, art therapy and yoga, for patients with cancer and their loved ones. The programs can help 
you feel better throughout your cancer experience. Through a wide range of services, you can learn tips 
for coping with symptoms and stress. These services are designed to enhance quality of life and help 
manage a broad range of physical and emotional symptoms. Cancer patients and their families use these 
methods as tools in which they may maintain health and wellness throughout and beyond treatment. 
Phone: 617-726-4178
Oncology Social Work
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Oncology social workers are licensed mental health professionals who provide support for issues that 
affect you and your family during cancer diagnosis, treatment, and recovery. Each disease center has its 
own social workers with expertise in your specific disease.
The Oncology Resource Specialist (a member of the Oncology Social Work team) can answer questions 
about transportation options for cancer patients and local lodging for patients and their families during 
treatment. We offer a variety of cancer support groups, but if needed the resource specialist can 
investigate if there are any offered closer to your home. Contact the Oncology Resource Specialist at: 
(tel) 617-724-0295.
More Supportive Care Services
Chaplaincy
Phone: 617-726-2220
Support is available to persons of all faiths and to those with no religious affiliation.
Environmental Music Program
The Mass General Environmental Music Program brings live, high-quality music to public spaces in the 
hospital to create a calming and soothing environment for patients, families, and staff.
Education Workshops
Phone: 617-724-1822
Education workshops share the information that can help ease your fear and anxiety. They also let 
families and friends learn more about what their loved ones are going through. Topics include:

Chemotherapy

Radiation therapy

Clinical trials

Blood counts

Nutrition

Fatigue

Radiology

Exercising during treatment
Illuminations Program
Phone: 617-650-1143
Illuminations is a rotating art exhibit housed throughout the Mass General Cancer Center and many of 
its affiliate locations. The exhibit is intended to offer enlightenment and encouragement to patients, 
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families, staff, and friends of the Cancer Center as they receive care, provide care, or accompany loved 
ones.
Images Boutique
Phone: 617-726-3211
The oncology boutique carries a wide variety of specialized products and services, including wigs, hats, 
breast prostheses, mastectomy products and lymphedema sleeves. Patients can learn more about skin 
care and managing hair loss. Our specially trained staff will provide you with personalized advice and 
assistance, and will teach you ways to minimize and manage the changes in appearance resulting from 
cancer treatment. They will work with you to create a plan that will help you look and feel your best 
throughout and following treatment. The boutique is located in the Yawkey Center on the 9th floor. Ask 
the staff about the frequent shopping card, which offers additional savings at this boutique, along with 
other Mass General stores.
The Marjorie E. Korff Parenting At a Challenging Time (PACT) Program
Phone: 617-724-7272
This program provides individual support for cancer patients who have children in their lives. Working 
hand-in-hand with parents, PACT’s child psychiatrists and child psychologists offer age-specific guidance 
for helping children cope with a parent’s cancer.
Lifestyle Medicine Clinic 
Phone: 617-724-4000
The Lifestyle Medicine Program provides personalized one-on-one consultations for any patient with 
cancer or a history of cancer who wants to improve their physical fitness, nutrition, quality of life or 
cancer prognosis.
The Network for Patients and Families
This peer support program matches patients and family members with volunteers who are experienced 
in living with a similar type of cancer.
Palliative Care Program (Outpatient Services)
Phone: 617-724-4000
Our palliative care specialists focus on improving the quality of life of people facing serious illness. From 
the time of diagnosis, we provide expert management of pain and other symptoms; guidance with 
difficult treatment choices; and emotional and spiritual support for you and your family. Talk with your 
doctor or nurse for a referral.
Support Groups
Phone: 617-724-1822
Groups led by oncology social workers provide patients, their family members and their friends the 
chance to share information, gain support and learn how others cope with cancer. Support workshops 
provide you with a comfortable place to share how you feel and learn how others cope with cancer. 
Topics include:
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
Talking to your children about cancer

Finding faith and hope

Moving forward after cancer treatment
The Social Service Department at Massachusetts General Hospital offers many types of support groups, 
including groups for certain types of cancer, siblings of children with life threatening illnesses, and 
programs for parents of children with cancer.
Survivorship Program
Phone: 617-726-4920
Mass General has world class clinical programs aimed at overcoming challenges related to quality of life, 
cardiopulmonary fitness, neurologic complications of cancer therapy, sexual health, and many other 
issues that impact cancer survivors.  Our survivorship program is helping to coordinate these activities 
across Mass General and ensure that all patients who can benefit have access to these services.
Howard Ulfelder, MD, Healing Garden
The Healing Garden is a year-round respite for Cancer Center patients, families and friends. This rooftop 
garden allows patients, families and visitors to enter into a landscaped setting for rest and solace. An 
enclosed, glazed pavilion provides shelter from the elements. Created as a serene respite for cancer 
patients and their families, the garden has extraordinary views of the Boston skyline and the Charles 
River Basin, generous seating, gentle water courses, and plentiful greenery year-round. The garden is 
accessible from the eighth floor in the Yawkey Center for Outpatient Care.
CANCERCare
CANCERCare offers counseling, support groups (via phone, online, and in person), education workshops, 
financial resources, and community programs for patients and caregivers. Learn more at: 
https://www.cancercare.org/
Project Bread
Project Bread is committed to preventing and ending hunger in Massachusetts. If you or your family is 
facing hunger right now, we want to help. Call our FoodSource Hotline at 1-800-645-8333 or visit 
http://www.projectbread.org/get-help/ to find resources that can make a real difference.
https://www.massgeneral.org/cancer/experience/
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EE. Partners Rally Recruitment Advertisement
Rally at Partners Healthcare
Do you have a new cancer diagnosis and a
history of major depression, bipolar or
schizophrenia?
This PDF is intended for IRB review and includes information that may not appear to the public. A preview
of what will appear on the Rally site is available at the link below.
https://rally.partners.org/preview/ujaN2N
Rally collects some information (e.g., gender eligibility and study activities) using structured fields. Options
that were available but not selected appear in this document in light grey with a strikethrough
The Basics
Headline
Do you have a new cancer diagnosis and a history of major depression, bipolar or schizophrenia?
Summary
It is challenging to cope with cancer. The Bridge study aims to understand if it is helpful for patients with
mental illness to be connected to a psychiatrist and case manager at the time of cancer diagnosis.
Project Title
Bridge: Proactive Psychiatry Consultation and Case Management for Patients with Cancer
Custom URL
https://rally.partners.org/study/bridge
Category
• Cancer
• Mental Health
Project Image
Project Website
(empty)
ClinicalTrials.gov Identifier
NCT03360695
Funding Source
NIH or Other Federal
At which institutions is the project being conducted?
Organization Name
Massachusetts General Hospital
Department
Cancer Center
IRB Organization
Dana Farber Cancer Institute
IRB Protocol Number
17396
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Recruitment Start Date
12/11/2017
Recruitment End Date
05/15/2022
Team
Principal Investigator
Kelly E Irwin, MD, MPH
Email Address (for internal use only)
kirwin1@partners.org
Phone Number (for internal use only)
6176434453
PI Organization
Massachusetts General Hospital
Project Contact
Catherine Pappano/Clinical Research Coordinator, cpappano@mgh.harvard.edu, 617-643-6087
Research
What are you studying?
It is challenging to cope with cancer. We want to understand if having a psychiatrist and case manager
be part of your care team improves your cancer care.
Why is it important?
Many people with illnesses like major depression, schizophrenia and bipolar disorder face barriers to
receiving high quality cancer care. It can be difficult to get to appointments, have many different doctors,
and experience depression or worry. Better communication between the patient, the oncology team, and
mental health providers may improve care. As for all patients, it is important for people with mental illness
to have access to high quality cancer treatment that is patient-centered and coordinated. Having a case
manager and psychiatrist at the cancer center who collaborates with the oncology team starting at cancer
diagnosis may help patients to receive the cancer care that they need.
What do you hope to accomplish?
We hope to examine the potential benefits of involving a psychiatrist and case manager in cancer care,
and how we may improve person centered care in the future. Your participation can help us learn how to
provide better care for people with cancer and mental health concerns.
Clinical Trial Phase
This project does not study a drug or biologic product. Not applicable.
Eligibility
Who can participate?
Recent diagnosis of breast, lung, gastrointestinal or head and neck cancer. Receiving cancer treatment
at MGH History of mental health concerns, including major depression, bipolar disorder, or
schizophrenia spectrum disorder English speaker Over the age of 18
Who cannot participate?
Unwilling or unable to participate in the study Unable to speak or read English Recurrence of the same
cancer type
Age
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18 years or older
Gender
Male
Female
Transgender Female
Transgender Male
Gender-expansive
Participation Details
Estimated time commitment
5 hours over 24 weeks
What may participants be asked to do?
Participants will be asked to complete 4 brief surveys and clinical interviews over 24 weeks. Some
participants will also have study visits with a psychiatrist and social worker. You may choose to identify a
caregiver to participate in the study, but this is not required. Participation involves no extra costs. You
have an equal chance of either: 1. Having a psychiatrist and case manager be part of your cancer care
team OR 2. You and your oncologist being informed about available mental health supports
Does your project involve any of the following activities?
Survey
Office visit
Travel Requirements
No travel required
Benefits and Compensation
What will participants receive?
You may receive up to $50 for your participation in this study.
Select all that apply
Payment
Dollar Amount (up to)
$50.00
Preview URL
https://rally.partners.org/preview/ujaN2N
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FF. Clinician Flyer
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KK.
Qualitative Interview Guide: Persons with cancer and mental illness 
Section 1: INTRODUCTION
Hi, my name is __________________ and I am a researcher calling from Massachusetts General 
Hospital. I’m calling to understand more about your experience with the Bridge study (talking with the 
psychiatrist [give name] and/or social worker Amy Corveleyn) when you were receiving cancer care. 
As a reminder, we are interested in learning about the experience of people affected by cancer and mental 
health needs. We are hoping to find out about your experiences as a patient, your perspective about your 
care, and your thoughts about being connected to the Bridge mental health team at the cancer center. 
We are interested in all of your ideas and appreciate you responding as honestly as you can. I’m interested 
in hearing all of your ideas- there is no right or wrong answer. If you don’t want to answer a particular 
question, you can choose not to answer. You can stop the interview at any time.  
This interview should last 30-40 minutes. Is it okay for me to record our conversation so that I can 
remember what you are sharing today?  The only people who will look at your responses will be our 
trained research staff.  If we use the information you share, such as for publication, we will do so in a way 
that you cannot be personally identified. After the interview, I will pay you $30 in cash or check, 
whichever your preference, to thank you for your time. (State that you are turning on the recorder).
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Part A: Introduction
1) How are you doing today? 
2) We sometimes use the word “caregiver” to describe family, friends, or community supports. 
Different people use different words to describe their role supporting or caring for others. 
Prompts:
Is there someone you identify as a caregiver? 
Would you use the word caregiver? If not, what words do you prefer (e.g., loved one, 
family, staff)?
Do you have a more than one caregiver?
Note: If a person prefers to use a word other than “caregiver” to describe themself, use that person’s 
language throughout the interview.
3) If you have a support or caregiver* (use person’s language), what did they do as a caregiver* (use 
person’s language) for you prior to the cancer diagnosis?
Optional prompts:
Related to mental health care?
Related to medical care
Related to other needs (transportation, food, housing, helping with medications)?
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4) How did the pandemic affect the way you interacted with:
Prompts:
Caregivers (e.g., family, friends, community staff)?
Mental health team?
Primary care?
Prompts: 
Positives?
Negatives?
Part B: Experience with cancer diagnosis and treatment 
Transition: Now, we would like to focus on the time of your diagnosis with cancer and the next 6 months 
when were you enrolled in the Bridge study from (give patient’s enrollment date) to (give patient’s end of 
24-week window date).
1) Looking back at the time of your cancer diagnosis and treatment, what was most challenging for 
you?
Prompts:
Related to cancer diagnosis?
Mental health?
Financial burden/resource needs?
*Note: The following question (#2) should only be asked to patient participants who identified a 
caregiver.
2) How did your relationships with your caregiver* (use person’s language) change during cancer 
care?
Prompts:
Changes in relationship/deepening of bond
Time together
Other?
Transition: Next, we would like to ask about your experiences related to participation in cancer care and 
communication with the oncology team.
1) How did the pandemic affect the way you were able to participate in cancer care?
Prompts:
Positives?
Negatives?  
Optional Prompts:
Delays in accessing cancer care?
Delays in accessing mental health care?
Having appointments in person?
Having caregivers* (use person’s language) attend appointments with you?
Participating in video visits?
Was that helpful? How so?
Joining patient appointments by phone? 
Was that helpful? How so? 
Challenges with virtual care?
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2) What was challenging about communicating with the oncology team (medical, radiation, surgical 
oncology team)?
Prompts: 
Knowing who to contact?
Waiting for responses?
During transitions in care (from hospital to home or rehab)?
3) What worked well to communicate with the oncology team?
Prompts:
What strategy/strategies worked best? 
What modality (e.g., phone, email, page, Patient Gateway)?
Part C: Experience Collaborating with the Bridge Team at Mass General as a Caregiver (use 
person’s language) During Cancer Care
Transition: Next, I want to ask you about your experience in the Bridge study. Participants were able to 
meet with a psychiatrist and social worker (names) during the 24-week trial that was focused on the time 
period of cancer treatment. (Provide dates of enrollment in the Bridge study). 
1) Thinking back, what do you remember about working with the Bridge team when you were 
diagnosed with cancer? 
Prompts:
Social work?
Psychiatry?
Navigator?
2) How, if at all, did working with the Bridge team affect your cancer care?
Prompts:
Ability to get needed cancer care?
Your understanding of your cancer?
Decision-making about cancer treatment?
Ability to follow up with cancer care?
3) How was working with the Bridge team different from your previous experiences working with 
other providers or clinicians?
Prompts:
How was working with the psychiatrist different from your psychiatrist?
How was working with the social worker different from working with other social 
workers/therapists?
How was working with the navigator different than previous experiences?
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How was it different than working with your psychiatrist, primary care doctor, or 
therapist? 
Team from DMH or VNA?
4) Was it helpful for a psychiatrist to be involved in the Bridge study? 
Prompts:
If helpful, how so?
If not, why not?
Optional prompts:
Expertise in mental illness/medical aspects of cancer care?
Expertise in psycho-oncology and serious mental illness?
Need for medication changes?
5) Did you have a joint visit with a member of the Bridge team and your oncology team?  
Prompts:
If so, was that helpful? How so?
6) For many patients, the pandemic affected the way they interacted with their healthcare providers. 
How did the pandemic affect the way that you and your healthcare providers interacted? 
Prompts:
Positives?
Negatives?
7) Did you see the Bridge team in person?
Prompt if yes: 
How did that affect your relationship/rapport?
Prompt if no: 
Was there a time that you think that would have been helpful? When?
8) What strategies worked best for you when meeting with/trying to each the Bridge team?
Prompts: 
Phone visits?
Virtual/video visits?
Text between visits?
Email between visits?
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Part D: After Completion of the Study (give date)
Transition: Next, I want to ask you about after the Bridge study ended. As a reminder, you completed the 
study on (give patient’s 24-week end date).
*Note to interviewer: The following question (#1) should not be asked if the patient did not identify a 
caregiver.
1) Currently, how would you describe your role or relationship with your caregiver* (use person’s 
language)?
Prompt:
How has your relationship with your caregiver changed since completing the study?
2) After completing the study, what issues are most on your mind as someone who has experienced 
cancer and mental illness?
Prompts:
Worries about your health?
Cancer recurrence?
Mental health symptoms/relapse?
Not being able to access care?
Financial burden?
3) Do you continue to be in touch with the Bridge team?
4) How was the transition to community-based mental health care?
Prompts:
Psychiatry/NP? Therapy? Other supports?
How to better support communication with oncology and mental health?
Resources/information that would better support that transition?
 
Part E: Patient Resource Interest
Dana Farber
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Introduction: Different patients have different needs and availability during cancer care that change over 
time.  
1) What do you think would support other people who are experiencing mental illness and cancer?
Prompts: 
During cancer care?
After cancer treatment?
Approaching end of life?
2) Would you be interested in:
Individual support for people with mental illness/cancer? 
Referrals to recommended therapists?
Group support with others experiencing mental illness/cancer?
Link to others experiencing mental illness and cancer/peer supports?
Participation in educational events?
Assistance with resources/financial burden related to mental illness treatment/cancer 
care?
Do you prefer in person, phone, or video-conferencing? 
3) Is there anything that you would like to bring up that we did not address? 
Conclusion: Thank you very much for your time and feedback.  
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LL.Qualitative Interview Guide: Caregivers of persons with cancer and mental illness 
Section 1: INTRODUCTION
Hi, my name is __________________ and I am a researcher calling from Massachusetts General 
Hospital. I’m calling to understand more about your experience with the Bridge study (talking with the 
psychiatrist [give name] and/or social worker Amy Corveleyn) when (patient’s name) was receiving 
cancer care. 
As a reminder, we are interested in learning about the experience of people who have been involved in 
helping to care for people affected by cancer and mental health needs. We are hoping to find out about 
your experiences as a caregiver, your perspective about the person’s care, and your thoughts about being 
connected to the Bridge mental health team at the cancer center. 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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We are interested in all of your ideas and appreciate you responding as honestly as you can. I’m interested 
in hearing all of your ideas- there is no right or wrong answer. If you don’t want to answer a particular 
question, you can choose not to answer. You can stop the interview at any time.  
This interview should last 30-40 minutes. Is it okay for me to record our conversation so that I can 
remember what you are sharing today?  The only people who will look at your responses will be our 
trained research staff.  If we use the information you share, such as for publication, we will do so in a way 
that you cannot be personally identified. After the interview, I will pay you $30 in cash or check, 
whichever your preference, to thank you for your time. (State that you are turning on the recorder).
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Section 2: CARING FOR (identify specific patient)
Part A: Introduction
Introduction: Thank you for making the time to talk today. 
5) How are you doing today? 
6) We sometimes use the word “caregiver” to describe family, friends, or community supports who 
care for individuals affected by cancer and mental health needs.  Different people use different 
words to describe their role supporting or caring for others. 
Prompts: 
How would you describe your role or relationship with _______________?
Do you use the word caregiver?
If not, what words do you relate to/prefer (e.g., loved one, staff)?
Note: If a person prefers to use a word other than “caregiver” to describe themself, use that person’s 
language throughout the interview.
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7) What were you doing as a caregiver* (use person’s language) for ______ before his/her cancer 
diagnosis?
Optional prompts
Related to mental health care
Related to other needs
Part B: Caregiving During Cancer Care
Transition: Now, we would like to focus on the time when _____ was diagnosed with cancer and 
enrolled in the Bridge study from (give patient’s enrollment date) to (give patient’s end of 24-week 
window date).
1) Looking back at the time of ______’s cancer diagnosis and treatment:
What were you doing as a caregiver for _____?
Related to their cancer?
Related to their mental health?
Related to patient needs like food, or transportation
2) Were other caregivers involved in supporting _____?
Positives of having multiple caregivers?
Negatives?
3) How did your role as a caregiver* (use person’s language) change after the person’s cancer 
diagnosis? During the person’s cancer care? 
Prompts: 
What contributed to changes in what you were doing as a caregiver?
The patient’s health needs (related to cancer, related to mental health?)
The patient’s financial resources/situation?
Changes in your relationship?
Caregiver* (use person’s language) needs
*Note: The following question (#4) should be asked to community caregivers only.
4) How did caregiving* (use person’s language) for _____ affect your ability to do your job as 
community mental health staff?
Prompts: 
What issues came up?
How did transitions in staffing affect the person’s care?
5) What parts of caregiving* (use person’s language) for _______ during cancer were challenging?
Prompts
What was most challenging?
Optional prompts:
Limited time?
Financial burden?
Emotional burden?
Balancing need to be a caregiver for others?
How did this change during the pandemic?
6) What aspects of caring* (use person’s language) for ____ were rewarding for you?
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Prompts:  
Spending time together?
Fulfillment from providing care/meeting needs?
Strengthening relationship/deepening bond? 
7) For many caregivers* (use person’s language), the pandemic affected the way that they interacted 
with loved ones or people they care for.  How did the pandemic affect the way you and  ____ 
interacted?
Prompts: 
Positives?
Negatives?
Transition: Next, we would like to ask about your experiences related to participation in _____’s cancer 
care and communication with the oncology team.
1) What was challenging about communicating with the oncology team (medical, radiation, surgical 
oncology team)?
Prompts: 
Knowing who to contact?
Waiting for responses?
During transitions in care (from hospital to home or rehab)?
2) What worked well to communicate with the oncology team?
Prompts:
What strategy/strategies worked best? 
What modality?  (e.g. phone, email, page)
3)  For many caregivers* (use person’s language) and loved ones, the pandemic changed how they 
were able to participate in cancer care.  How did the pandemic affect the way you were able to 
participate in cancer care?
Prompts:
Positives?
Negatives?
Optional Prompts:
Joining appointments in person?
Was that helpful? How so?
Visiting in person in the hospital?
Was that helpful? How so?
Participating in video visits?
Was that helpful? How so?
Joining patient appointments by phone? 
Was that helpful? How so?
Part C: Experience Collaborating with the Bridge Team at Mass General as a Caregiver (use 
person’s language) During Cancer Care
Transition: Next, I want to ask you about your experience while ____ was involved in the Bridge study 
(and you may have been enrolled as a caregiver). Patients were able to meet with a psychiatrist and social 
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worker (names) for 24 weeks of their cancer treatment. We are interested in your perspective about 
working with the Bridge team and your experience as a caregiver* (use person’s language). 
9) Thinking back, what do you remember about working with the Bridge team when ____ was 
diagnosed with cancer? 
Prompts:
Who do you remember talking to/connecting with? (psychiatrist, social worker, 
navigator)?
10) What did you find most helpful about being connected to the Bridge team during the person’s 
cancer care?
Prompts:
For the person/patient?
For you, as a caregiver*(use person’s language)?
11) How, if at all, did working with the Bridge team affect the person’s cancer care? 
Prompts:
Ability to get needed cancer care?
The person’s understanding of their cancer?
Decision-making about cancer treatment??
Ability to follow up with cancer care
12) How was working with the Bridge team different from your previous experiences working with 
____’s clinicians?
Prompts:
Working with _____’s mental health clinicians?   _____’s other doctors?
Your own experience with healthcare?  
13) Was it helpful for a psychiatrist to be involved in the Bridge study? 
Prompts:
If helpful, how so?
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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If not, why not?
Optional prompts:
Expertise in mental illness/medical aspects of cancer care?
Expertise in psycho-oncology and serious mental illness?
Need for medication changes?
14) As a caregiver, in what ways did you interact with the Bridge team during the study?
Part 1: Joint vs. Individual Visits
a) Did you meet together with the patient and Bridge team? Was that helpful? How so?  
b) Did you talk separately with the social worker or psychiatrist? Was that helpful/how so?
c) Did you meet together with the oncology team, the patient, and Bridge teams?   Was that 
helpful? How so? When?
15) Impact of the pandemic
The pandemic impacted how many caregivers were able to interact with mental health clinicians 
and virtual care rapidly expanded. 
Positives?
Negatives?
16) Did you see the Bridge team in person?
Prompt: if yes: How did that affect your relationship/rapport?
Prompt if no:  Was there a time that you think that would have been helpful?  When?
17) What strategies worked best for you when meeting with/trying to reach the Bridge team?
Prompts:
Phone visits
Virtual/video visits
Text between visits
Email between visits
Part D: After Completion of the Study (give date)
Note to interviewer: Tailor this section based on patient’s clinical course; will need to modify based on 
if patient died during the study.
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Transition: Next, I want to ask you about after the Bridge study ended. As a reminder, ______ completed 
the study on (give patient’s 24-week end date).
*Note to interviewer: The following question (#1) should not be asked if the patient has died.
5) Currently, how would you describe your role or relationship with __________?
Prompts: 
Do you consider yourself a caregiver?   
How has your role as a caregiver changed since completing the study?
6) After completing the study, what issues are most on your mind as a caregiver for _____ with 
cancer and mental illness?
Prompts:
Worries about the patient’s health?
Cancer recurrence
Mental health symptoms/relapse
Not being able to access care
Financial burden
Your needs 
Your wellbeing and mental health
Other caregiving responsibilities
Financial burden
7) Do you continue to be in touch with the Bridge team?
8) How was the transition to community-based mental health care?
Prompts:
Psychiatry/NP?  Therapy? Other supports?
How to better support communication with oncology and mental health?
Resources/information that would better support that transition?
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Part E: Caregiving Resource Interest
Introduction: Different caregivers* (use person’s language) have different needs and availability during 
cancer care that change over time.  
4) What do you think would support other caregivers* (use person’s language) for patients with 
mental illness and cancer?
Prompts: 
During cancer care?
After cancer treatment?
Approaching end of life?
5) Would you be interested in:
Individual support for caregivers? 
Referrals to recommended therapists?
Group support with other caregivers?
Link to other caregivers/peer supports?
Participation in educational events?
Assistance with resources/financial burden related to caregiving* (use person’s language) 
and access to care?
Do you prefer in person, phone, or video-conferencing? 
6) Is there anything that you would like to bring up that we did not address? 
Conclusion: Thank you very much for your time and feedback.  
-------------------------------------------------------------------------------------------------------------------------------
Section 3: DEMOGRAPHICS AND CAREGIVER* (use person’s language) CHARACTERISTICS 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Note: Ask only of caregivers* (use person’s language) who were not enrolled in trial.
Introduction: For these questions, please provide responses based on the time when _____ was 
diagnosed with cancer and the following 6 months. As a reminder, ______ was enrolled in the trial from 
(give enrollment date) to (give end of 24-week date). 
1. Date of birth (mm/dd/yyyy): _________________
2. Gender: __________________________________
3. Ethnicity
o Hispanic or Latino
o Not Hispanic or Latino
4. Race (please check all that apply)
American Indian or Alaskan native
Asian
African American or Black
Native Hawaiian or other Pacific Islander
White
Other 
4a. If other, please specify: ________________________
5. Religion
o
Catholic Christian
o
Other Christian (such as Protestant, Orthodox, etc.)
o
Jewish
o
Muslim
o
Atheist
o
None 
o
Other
6. What was your relationship status?
o
Married or living with someone as if married
o
Non-cohabitating relationship
o
Single, never married
o
Divorced/Separated
o
Loss of long term partner/Widowed
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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7. Please indicate your highest or current education level
o 11th grade or less
o High school graduate or GED
o 2 years of college/AA degree/Technical      school training
o College graduate (BA or BS)
o Masters degree
o Doctorate/Medical degree/Law degree
8. What is your annual combined household income?
o
Less than $25,000
o
$25,000 – 50,000
o
$100,000 - $150,000
o
Greater than $150,000
9. Please indicate who you lived with (you may check more than one box)
By myself
Partner/Spouse
Roommate/Friend
Children under 18
Children over 18
Group home/assisted living/nursing home
Parent
Other 
9a. If other, please specify: _______________________________________________________
9b. Did you experience a change in housing/living situation during the study? _________
10. Employment status during the study (please check all that apply):
Employed (full-time or part-time)
Caring for home or family (not currently employed and not looking for paid work)
Unemployed and looking for work
Unable to work due to illness or disability
Retired
Student
Other 
10b. If other, please specify: ______________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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11. Do you have medical conditions (including mental health conditions such as depression, anxiety) that 
might require ongoing care? 
o
Yes
o
No
11a. If so, what conditions? _____________________________________________
12. What was your relationship with the patient during the study?
Married or living as if married
Partner/Non-cohabitating relationship
Divorced/Separarated
Friend
Family Member 
Staff/provider: Worked with the patient through community mental health
Other
12a. If other, please specify: ___________
12b. If staff/provider, please describe your role
13. Please estimate the number of hours per week (on average) you were involved as a caregiver for the 
patient during the Bridge study:
o
1-2 hours per week
o
2-5 hours per week
o
5-10 hours per week
o
10-15 hours per week
o
Over 15 hours per week
14a. Did that amount of time spent caregiving* (use person’s language) change during the study?
o
Yes
o
No
14. Were others involved in caregiving* (use person’s language) for the patient?  
o
Yes
o
No
15a. If so, who and in what roles?
o
Family members: ______________________________________________________
o
Friends: _____________________________________________________________
o
Mental health staff: ____________________________________________________
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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15. Do you continue to consider yourself a caregiver for ________?
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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MM.
Qualitative Interview Guide: Mental health clinicians of persons with cancer and 
mental illness 
Section 1: INTRODUCTION
Hi, my name is ________________and I am a researcher calling from Massachusetts General Hospital.  
I’m calling to understand more about your experience as a mental health clinician for ______ when 
receiving cancer care and your experience collaborating with the Bridge team (talking with the 
psychiatrist [give name] and/or social worker Amy Corveleyn). 
As a reminder, we are interested in learning about your experiences as a mental health clinician working 
with patients with mental illness and cancer and your needs as a mental health clinician and how those 
needs have evolved during the pandemic. We are hoping to find out about your experiences as a 
caregiver, your perspective about the person’s care, and your thoughts about being connected to the 
Bridge mental health team at the cancer center.
We are interested in all of your ideas and appreciate you responding as honestly as you can. I’m interested 
in hearing all of your ideas- there is no right or wrong answer. If you don’t want to answer a particular 
question, you can choose not to answer.  You can stop the interview at any time.  
This interview should last about 30 minutes. Is it okay for me to record our conversation so that I can 
remember what you are sharing with me today? The only people who will look at your responses will be 
our trained research staff.  If we use the information you share, such as for publication, we will do so in a 
way that you cannot be personally identified. I am interested in hearing all your ideas - there is no right or 
wrong answer. If you do not want to answer a particular question, you can choose not to answer. After the 
interview, I will pay you $30 in cash or check, whichever your preference, to thank you for your time.  
(State that you are turning on the recorder).
-------------------------------------------------------------------------------------------------------------------------------
Section 2: CARING FOR (identify specific patient)
Part A: Before Enrollment in Bridge Collaborative Care Trial 
Introduction: Thank you for making the time to talk today. 
1) Please describe your involvement in this person’s mental health care before their cancer 
diagnosis.
Prompts:
How long had you been seeing ____?  
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Did you prescribe medications? 
Did you provide therapy? 
2) How did your role in _____’s mental health care change during the pandemic (before the 
cancer diagnos?
Prompts:
 
Positives?
Negatives?
See less often?
Not applicable
Part B: During Cancer Care
Transition: Next, we will focus on the time period after the person’s cancer diagnosis.  
1) How did the person’s mental health care change after the cancer diagnosis?
Prompts: 
Frequency of visits?
What aspects of caring for the patient were challenging?
What was rewarding?
How was the mental health care impacted by the pandemic?
Part C: The Bridge Collaborative Care Trial 
Transition: Next, I want to ask you about the Bridge collaborative care study 
that________________ was involved in.  During the study, patients had a proactive consultation 
with the Bridge team (a psychiatrist and social worker with expertise in serious mental illness 
and cancer) and collaboration with oncology over the next 24 weeks.  I’m interested in your 
perspective as a mental health clinician about the person’s cancer care and their involvement in 
the Bridge trial.
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Do you remember communicating with a member of the Bridge team? A social worker or 
psychiatrist (prompt with clinician names)?
1) How did working with the Bridge team (identify clinicians) impact your access to 
information about cancer diagnosis, prognosis or treatment?  
2) What the Bridge trial helpful for _____? How so?
3) Was the Bridge trial helpful for you, as a mental health clinician?
If so, what was most helpful?
Access to in person/more frequent visits?
Expertise in psycho-oncology care?
Direct communication with oncology team?
Collaboration with a social worker?
4) What was your experience communicating with the Bridge team? What worked best?  
Prompts:
What was helpful?
Frequency of communication?
Mode of communication?
How could the communication be more helpful to you?
Frequency of communication?
Mode of communication?
Content
What is the best way to communicate about urgent needs?
Part C: After Completion of the Bridge Collaborative Care Trial 
Transition: Next, I want to ask you about your experience after the study ended.  We appreciate 
your feedback as we hope to learn how to better support patients and their mental health 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Date__________
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clinicians throughout cancer care. As a reminder, ______ completed the study on (give patient’s 
24-week end date).
1) Please tell us about the experience of your patient transitioning from the Bridge trial. 
Prompts:
Has your role as a mental health clinician changed? If so, how? 
How frequently do you have visits with this patient?
2) What worried you about this patient returning to your practice?
Prompts:
Cancer of physical health needs
Mental health needs
Poverty related barriers with coming to care
3) Any challenges with the transition in mental health care?
4) Any challenges with cancer care?
5) Any ongoing worries or concerns?
6) Anything else you would like to add?
7) How could the Bridge team best support this transition in care?
Prompt:
Would it help to have the ability for ongoing consultation related to cancer 
care/psycho-oncology after completing the study for clinicians?
8) What could be improved to better support the transition in care to community mental 
health?
Prompts:
Clarifying roles?
Prescribing medication?
Giving the patient and/or caregiver a treatment summary?
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Direct communication with the oncology team?
Transition: Understanding that we all have limited time and resources, we are interested in your 
guidance about how to be most helpful to mental health clinicians caring for patients with mental 
illness and cancer.
1) What challenges do you face with communication with medical providers when your 
patients have acute/serious medical needs?
Prompts:
Difficulty with communicating across systems? (HIPAA)
Structure of clinic and schedule does not allow for care coordination
Lack of shared medical record? 
Limited time?
2) How has your experience as a mental health clinician for patients with serious mental 
illness changed during the pandemic?
Prompts:
Transition to telehealth?
What is working better regarding communication with other clinicians?
What has been more challenging regarding communication with other clinicians?
Culture of your work environment and how reimbursement works for care 
coordination?
Burden on you as a clinician and acuity of patients you are seeing?
Limited time
3) How is the care in the collaborative care trial different from other experiences 
coordinating with mental health clinicians?
Prompts:
Different from your practice?
Is there a need for an intervention like the Bridge trial in the community?
What other initiatives are happening in your setting related to telehealth/covid?
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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4) To what extent do you feel like you can try new things to change your practice?
5) Anything else you would like to share?
Conclusion: Thank you for your time and feedback.
---------------------------------------------------------------------------------------------------------------------
Section 3: DEMOGRAPHIC QUESTIONS 
1. Please select your clinical discipline: 
o Licensed Mental Health Clinician
o Social Work
o Psychology 
o Psychiatry
o Psychiatric Nurse Practitioner
o Primary Care Provider
o Other: ____________________
3. What year did you receive your license/start practicing independently? __________
5. Gender: _____________ 
4. In what setting do you see patients clinically now? Please check all that apply.
A private office
Community mental health clinic 
Academic hospital
Other: ________________
5. During the pandemic (March 2020 through August 2021), what proportion of your visits have 
occurred virtually (using phone or video-conferencing technology?
o Less than 25%
o 25-50%
o 50-75%
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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o 75-95%
o Nearly all visits
6. What proportion of those virtual visits (those by phone and videoconferencing) were by 
phone?
o Less than 25%
o 25-50%
o 50-75%
o 75-100%
7. Going forward, what proportion of your patients do you anticipate seeing using phone or 
video-conferencing technology?
o Less than 25%
o 25-50%
o 50-75%
o 75-95%
o Nearly all visits
8. Approximately how many patients with cancer and serious mental illness (schizophrenia, 
bipolar disorder, and/or major depressive disorder with prior psychiatric hospitalization) have 
you cared for?
o
<5
o
5-10
o
10-50
o
>50
9. How prepared do you feel to care for patients with cancer and serious mental illness?
o Very prepared
o Somewhat prepared
o Somewhat unprepared
o Not at all prepared
JJ.Qualitative Interviews Verbal Consent  
Bridge: Proactive Psychiatry Consultation and Case Management for Patients with Cancer 
 
Principal Investigator: Kelly Irwin, MD, MPH 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Contact information: Call 617-643-4453  
 
Purpose of the Research 
It can be challenging to cope with cancer, and many people with illnesses like major 
depression, schizophrenia, and bipolar disorder face barriers to receiving quality cancer care. 
You may have already participated in our randomized controlled trial as a patient, caregiver, or 
mental health clinician in which we investigated if having a psychiatrist and case manager as part 
of a patient’s team at the time of cancer diagnosis might improve cancer care
We are reaching out now to better understand your experience and learn more about barriers and 
challenges to accessing mental health and cancer care for people, families and caregivers affected 
by mental health and cancer across healthcare settings. 
 
Study Information 
We are asking you to participate in this study because we think you may help us better 
understand how to increase access to mental health and cancer care. All participants will undergo 
one approximately 30-minute, semi-structured, qualitative interview with trained study staff. 
This interview can be completed over the phone, by video call, or in-person, whichever is least 
burdensome. 
With your permission, we will audio record this interview. These recordings will be used for data 
analysis purposes only. If you do not want to be recorded, you may still participate. 
 
A description of this clinical trial will be available on www.ClinicalTrials.gov, as 
required by U.S. Law. This website will not include information that can identify you. At most, 
the website will include a summary of the results. You can search this website at any time. 
 
Potential Risks and Discomforts 
This study does not have any physical risks. You will not be injured or become physically sick 
because of participating in this study. Some of the interview questions may be upsetting. If any 
of the questions upset you, you can talk to your doctor or members of the study team. If your 
responses indicate that you are in severe distress, a study clinician will call you to follow-up and 
assess your safety. At that point, you may be offered a referral to appropriate services, which you 
may accept or decline. 
If your responses to the interview are audio-recorded, that data will be used only by study staff 
and will be protected by a password. Your identity will be kept confidential and we will be 
extremely careful to protect your privacy. Taking part in this interview will not lead to any costs 
to you or your insurance company.
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Date__________
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Benefits 
All study participants will receive $30 in cash or check, whichever your preference, to thank you 
for your time completing the interview. Your participation may also help us understand how to 
better help people who have mental illness and cancer, as well as how to better help their 
caregivers.
 
Confidentiality  
There is little risk involved with study participation. We will be extremely careful to protect your 
privacy and health information by locking survey material and audio recorders in file cabinets 
and storing data and audio recordings on password protected computers. Only our study team can 
access this information.  Your responses will be kept confidential. You can stop participating in 
the study at any time. If the results of this research study are published in a medical journal, they 
will not identify individual participants.
A Certificate of Confidentiality from the Department of Health and Human Services has been 
issued on this study as an additional protection of your privacy. Despite the study team’s 
precautions, you will also need to also actively protect your own privacy.  
 
Participation 
 
Please note that participation in this study is completely voluntary and will not affect 
your medical care or at the Massachusetts General Hospital or your access to Department of 
Mental Health services. You can stop participating in the research study at any time. We 
appreciate your time and consideration.  
 
Contact Information 
 
If you have questions about the study, please contact: 
Research assistant: Zoe Nelson (617-726-2297), M-F 9am-5pm.  
Principal investigator (licensed psychiatrist): Dr. Kelly Irwin (617-643-4453)  
 
 
For questions about your rights as a research participant, please contact a representative 
of the Office for Human Research Studies at DFCI (617) 632-3029. This can include questions 
about your participation in the study, concerns about the study, a research related injury, or if you 
feel/felt under pressure to enroll in this research study or to continue to participate in this 
research study. 
 
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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DELPHI CONSENSUS METHOD
A. Clinician Introductory Email
Dear (Insert Name),
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202

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Based on your expertise in [breast, thoracic, gastrointestinal, or head and neck] cancer, 
Dr. Kelly Irwin hopes you will consider participating as a member of a Delphi consensus panel. 
The aim of this consensus panel is to create metrics to identify changes in [breast, thoracic, 
gastrointestinal, or head and neck] cancer care that could impact cancer outcomes (e.g. 
deviations from stage-appropriate treatment) for underrepresented and underserved populations. 
The Delphi method is an iterative, multistage survey technique, which is commonly used 
in health and social sciences to generate group consensus from a panel of expert opinions. For 
more information on the Delphi method, please refer to (Hasson F, Keeney S, & McKenna H. 
Research Guidelines for the Delphi survey technique. Journal of Advanced Nursing. 2000: 32(4), 
1008-1015). 
The study will consist of 4 rounds of questionnaires, over the course of several 
months. We expect each survey to take no longer than 20 minutes to complete, and you will be 
compensated $100 for completion of all 4 rounds of questionnaires. The data collected from this 
survey will directly impact future cancer care research, as well as inform Dr. Irwin’s trial on 
facilitating appropriate and effective collaborate care among cancer patients with mental illness.
If you have any other questions or concerns please do not hesitate to reach out to us 
directly at (study email). 
Sincerely,
____
Dana Farber
IRB NUMBER: 17-396
IRB APPROVAL DATE: 10/01/202