Psychological Intervention for Caregivers of Patients With Malignant Gliomas
Phase: NA
Conditions: Malignant Glioma
Sponsor: Massachusetts General Hospital

PROTOCOL TITLE: 
Psychological Intervention for Caregivers of Patients with Malignant Gliomas 
NCT 03735498 
 
PRINCIPAL INVESTIGATOR:  
Deborah A. Forst, MD 
Neuro-Oncology 
617-726-2000 
dforst@partners.org 
 
VERSION NUMBER: 1.6 
 
DATE: February 2, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Contents 
 
1.0 
Objectives ........................................................................................................................................ 4 
2.0 
Background ...................................................................................................................................... 4 
3.0 
Inclusion and Exclusion Criteria ...................................................................................................... 5 
4.0 
Study-Wide Number of Subjects ..................................................................................................... 6 
5.0 
Study-Wide Recruitment Methods .................................................................................................. 6 
6.0 
Multi-Site Research ......................................................................................................................... 6 
7.0 
Study Timelines ............................................................................................................................... 6 
8.0 
Study Endpoints ............................................................................................................................... 6 
9.0 
Procedures Involved......................................................................................................................... 6 
10.0 Data and Specimen Banking ............................................................................................................ 9 
11.0 Data Management and Confidentiality ............................................................................................ 9 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .................................................. 11 
13.0 Withdrawal of Subjects .................................................................................................................. 11 
14.0 Risks to Subjects ............................................................................................................................ 11 
15.0 Potential Benefits to Subjects ........................................................................................................ 12 
16.0 Vulnerable Populations .................................................................................................................. 12 
17.0 Community-Based Participatory Research .................................................................................... 12 
18.0 Sharing of Results with Subjects ................................................................................................... 12 
19.0 Setting ............................................................................................................................................ 12 
20.0 Resources Available....................................................................................................................... 12 
21.0 Prior Approvals .............................................................................................................................. 13 
22.0 Recruitment Methods ..................................................................................................................... 13 
23.0 Local Number of Subjects ............................................................................................................. 13 
24.0 Provisions to Protect the Privacy Interests of Subjects .................................................................. 13 
25.0 Compensation for Research-Related Injury ................................................................................... 14 
26.0 Economic Burden to Subjects ........................................................................................................ 14 
27.0 Consent Process ............................................................................................................................. 14 
28.0 Process to Document Consent in Writing ...................................................................................... 14 
29.0 Drugs or Devices............................................................................................................................ 14 
30.0 References ...................................................................................................................................... 14 
31.0 Appendix ........................................................................................................................................ 17 
31.01 7-Item Generalized Anxiety Disorder (GAD-7) ............................................................................. 17 
31.02 Hospital Anxiety and Depression Scale (HADS) ............................................................................ 18 
31.03 Brief Demographic Survey .......................................................................................................... 20 
31.04 Locator Form ............................................................................................................................ 21 
31.05 Caregiver Oncology Quality of Life ............................................................................................. 22 
31.06 Caregiver Reaction Assessment ................................................................................................... 25 
31.07 Lewis Cancer Self-Efficacy Scale ................................................................................................ 26 
31.08 Measure of Current Status ........................................................................................................... 28 
31.09 Qualitative Exit Interview ........................................................................................................... 29 

31.10 Oncologist Permission to Approach Email Template ...................................................................... 34 
31.11 Letter Template for At-Home Survey Completion by Mail .............................................................. 35 
31.12 Template for REDCap Survey Invitation ...................................................................................... 36 
31.13 Phone Script for Survey Administration ........................................................................................ 37 
31.14 Phone Script for Exit Interview .................................................................................................... 38 
31.15 Caregiver Intervention Manual for Psychological Intervention for Caregivers of Patients with Malignant 
Gliomas ............................................................................................................................................. 39 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
1.0 
Objectives 
1.1 Study Rationale 
Our primary goal is to conduct a pilot study of a population-specific psychological intervention aimed at 
decreasing anxiety and promoting coping in caregivers of patients with malignant gliomas.  In this initial 
phase of the research, we will pilot the intervention with 25 malignant glioma caregivers in order to 
assess feasibility and acceptability of the intervention. 
 
1.2 Specific Aims 
1) To refine a caregiver-directed intervention and study protocol based on acceptability feedback from 
an open pilot study with exit interviews. 
 
2.0 
Background 
2.1 Introduction 
Malignant gliomas are the most common types of brain tumors and have a disease course characterized 
by high symptom burden and rapid cancer progression.1,2  Survival of patients with glioblastoma, the most 
common type of malignant glioma, is on the order of 15 months, even in patients treated aggressively with 
chemotherapy and radiation.1,3,4 Thus, a diagnosis of malignant glioma has a significant impact on a 
patient’s family and friends (“caregivers”). There is increasing recognition that caregivers who experience 
substantial distress related to their loved one’s serious medical illness have worse physical and 
psychological health, which also may negatively impact the patient’s health and outcomes.5-14 Caregivers 
of patients with brain tumors face significant challenges due to the impact of the cancer on the patients’ 
central nervous system. Specifically, these caregivers must cope with their loved one’s progressive 
cognitive decline, personality and behavior changes, and accumulation of neurological deficits as the 
disease progresses.15-18  This is physically, financially and emotionally draining, and caregivers of patients 
with malignant gliomas experience poor quality of life and high rates of psychological distress.19-21 We 
conducted a prospective study of patients with newly diagnosed malignant glioma and their caregivers 
(DF/HCC 15-500), with preliminary results demonstrating that more than 50% of caregivers had 
clinically significant anxiety at the time of their loved one’s diagnosis, with almost two-thirds 
endorsing anxiety over their course of illness. Despite the high rates of distress in caregivers of patients 
with malignant gliomas, few interventions have been developed to address the unique supportive care and 
coping needs of this highly burdened caregiver population.19  
 
The goal of this proposal is to pilot a population-specific psychological intervention aimed at 
decreasing anxiety and promoting coping in caregivers of patients with malignant gliomas. Our 
intervention is based on a conceptual framework for caregiver-directed interventions developed by our 
multi-disciplinary team.  We recently used this framework to develop an intervention for caregivers of 
patients undergoing bone marrow transplantation, which was highly acceptable and beneficial to 
caregivers who participated in the open pilot study. While the proposed intervention is based upon this 
framework, we have used qualitative data collected from caregivers of patients with malignant glioma 

(DF/HCC 15-500 and DF/HCC 18-171) to refine the intervention and ensure that it is targeted to the 
specific needs of this caregiver population. Our study population will include caregivers within the first 
six months of their loved one’s diagnosis with malignant glioma who report clinically significant anxiety. 
We opted to enroll caregivers with clinically significant anxiety as they are in greatest need of a behavioral 
intervention focused on their distress and concerns about their loved one’s health and diagnosis. Enrolled 
caregivers will participate in six weekly, cognitive-behavioral therapy-based, individual sessions with a 
mental health clinician, designed to provide them with the strategies and coping skills to manage the 
distress related to their loved one’s illness. Findings from this project may inform the development of a 
future randomized efficacy trial to demonstrate the impact of the intervention on caregivers’ psychological 
outcomes, coping, and well-being. 
 
3.0 
Inclusion and Exclusion Criteria 
 
The population for this study will include English-speaking adults (age ≥ 18) who are the primary 
caregiver for an individual diagnosed with a malignant glioma within the past 6 months and present for 
cancer care at the Massachusetts General Hospital Cancer Center, Boston, MA. The caregiver must also 
have at least mild anxiety symptoms, defined as a 7-Item Generalized Anxiety Disorder (GAD-7) score 
of 5 or greater. See Table 1 for a summary of study inclusion/exclusion criteria: 
 
Table 1. Study Inclusion/Exclusion Criteria  
 
Rationale for inclusion/exclusion: This research is focused on developing an intervention for caregivers 
with malignant gliomas. Only participants within 6-months of their loved one’s brain tumor diagnosis are 
eligible to participate, as the intervention is targeted at the stressors caregivers may face during this time. 
Participants must be able to speak and read in English as we do not have the resources to conduct the 
intervention in additional languages.  Participants must report clinically significant anxiety symptoms, 
defined as a Generalized Anxiety Disorder Scale (GAD-7) score ≥5, as our intervention intends to address 
anxiety symptoms in caregivers. Caregivers deemed inappropriate for the study by the patient’s clinician 
or the study PI will be ineligible to participate. Pregnant women will be included in the study. Adults 
unable to consent, individuals who are not yet adults, and prisoners will not be included. 
 
Screening for eligibility 
Inclusion Criteria 
Exclusion Criteria 
Age ≥ 18 
Deemed inappropriate for the study by the 
patient’s clinician or the study PI 
Identified by a patient with a malignant glioma 
(WHO Grade III or IV glioma) as the patient’s 
primary caregiver 
 
The patient is receiving care at the MGH Cancer 
Center 
 
The patient was diagnosed with a malignant glioma 
within the past 6 months 
 
Able to speak and read in English 
 
Generalized Anxiety Disorder 7-item (GAD-7) 
score ≥5 
 
Participants may or may not be pregnant. 
 

Study staff will review the outpatient clinic schedule for the Yawkey 9E Brain Tumor Clinic to identify 
patients with malignant gliomas.  To facilitate identification of potential participants and assess eligibility, 
study staff will review minimum necessary medical record data via a HIPAA waiver. This will ensure that 
caregivers are potentially eligible to participate in the study prior to contacting them to obtain informed 
consent. Prior to contacting potential participants identified via screening, the patient’s primary treating 
oncologist will be contacted to inform them that we plan to approach the patient’s caregiver for study 
participation and to inquire about any concerns regarding study participation. If clinicians have specific 
concerns about the appropriateness of enrolling a particular caregiver, we will not contact that caregiver. 
 
4.0 
Study-Wide Number of Subjects 
N/A 
 
5.0 
Study-Wide Recruitment Methods 
N/A 
 
6.0 
Multi-Site Research 
N/A 
 
7.0 
Study Timelines 
As this cognitive-behavioral therapy-based intervention consists of 6 weekly or biweekly sessions with a 
mental health clinician, an individual subject will participate for approximately 6 to 12 weeks. We 
anticipate that all study subjects will be enrolled within 18 months and that the study will be complete 
by January 2020. 
 
8.0 
Study Endpoints 
The primary endpoint of this study is feasibility of the intervention.  In an exploratory analysis, we will 
examine preliminary efficacy of the intervention in improving caregiver-reported outcomes from baseline 
to post-intervention. 
 
9.0 
Procedures Involved 
9.1 Recruitment 
Study staff will review the outpatient clinic schedule for the Yawkey 9E Brain Tumor Clinic to identify 
patients with malignant gliomas.  To facilitate identification of potential participants and assess 
eligibility, study staff will review minimum necessary medical record data via a HIPAA waiver. This 
will ensure that caregivers are potentially eligible to participate in the study prior to contacting them to 
obtain informed consent. Prior to contacting potential participants identified via screening, the patient’s 
primary treating oncologist will be contacted to inform them that we plan to approach the patient’s 
caregiver for study participation and to inquire about any concerns regarding study participation. If 
clinicians have specific concerns about the appropriateness of enrolling a particular caregiver, we will 
not contact that caregiver. 
 
9.2 Enrollment 
A member of study staff (e.g. PI, Research Assistants) will obtain informed consent in person prior to 
initiating any study measures. Participants will be consented next time they are in clinic. Research 

assistants, all of whom previously have received CITI and consent training, will be provided study-
specific recruitment training. Caregivers who would like more time to consider participation at in-clinic 
approach are able to take the consent forms home with them to review. Caregivers will be provided with 
study staff contact information if any questions or concerns regarding the research arise.  
 
9.3 Registration 
Study staff will register eligible participants in the Clinical Trials Management System (CTMS) OnCore 
as required by DF/HCC SOP REGIST-101 after the participant completes the brief enrollment survey. 
Caregivers who report GAD-7 scores <5 will be considered ineligible for the study and will not be 
registered in OnCore. If a caregiver’s GAD-7 score renders them ineligible but they are still interested in 
the study, we will re-approach them in 3 months to re-administer the GAD-7. Caregivers who do not 
complete the brief enrollment survey will not be registered in OnCore.  
 
9.4 Study design 
This study will be a prospective, single-arm pilot study to assess feasibility and acceptability of a 
psychological intervention for caregivers of patients with malignant gliomas.  We will use qualitative 
data to refine a multicomponent psychological intervention specifically targeting the needs of caregivers 
of patients with malignant gliomas who are within the first 6 months of diagnosis.  We will collect 
demographics at baseline and will ask caregivers to complete a questionnaire pre- and post-intervention 
to assess caregivers’ self-reported information about mood, caregiver burden, coping, quality of life and 
illness understanding. 
 
9.5 Selection of Instruments 
 
9.5.1 7-Item Generalized Anxiety Disorder (GAD-7) 
The GAD-7 (Appendix 31.01)22 is a valid self-report measure for assessing generalized anxiety24 in 
patients with cancer.23 Patients indicate how often they have been bothered by symptoms over the last 2 
weeks using a likert-type scale ranging from 0 (Not at all) to 3 (Nearly every day). Scores of 5 to 9 are 
categorized as mild anxiety, scores of 10 to 14 as moderate anxiety, and scores of 15 or greater as severe 
anxiety. Patients with scores ≥ 5 on the GAD-7 (mild symptomatology) will be eligible for 
participation.25 The estimated time for completing this scale is 1-3 minutes. 
 
 
9.5.2 Hospital Anxiety and Depression Scale (HADS) 
We will use the Hospital Anxiety and Depression Scale (HADS) to assess symptoms of depression and 
anxiety in all study participants. The HADS is a 14-item questionnaire that contains two 7-item 
subscales assessing depression and anxiety symptoms during the past week (Appendix 31.02)26. Used 
extensively in samples of patients with cancer and their caregivers, the questionnaire consists of a four-
point item response format that quantifies the degree to which participants experience mood symptoms. 
Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant 
anxiety or depression.  The estimated time for completing this scale is 2-5 minutes. 
 
9.5.3 Brief Demographic Survey 

This includes self-reported information about participants’ gender, race, ethnicity, religion, education, 
relationship status, household members, employment status, relationship to the patient, and years they 
have known the patient. It is estimated that these questions (Appendix 31.03) will take approximately 1-
3 minutes to complete. 
 
9.5.4 Locator Form 
This includes self-reported contact information for participants and information necessary for 
registration in OnCore, including full name, address, phone number(s), email address, and date of birth. 
It also asks participants their preferred mode of communication with the study team (phone, text, or 
email). It is estimated that these questions (Appendix 31.04) will take approximately 1-3 minutes to 
complete. 
 
9.5.5 Caregiver Quality of Life (QoL) 
We will use the CareGiver Oncology QoL questionnaire (CarGOQoL), a 29-item, well-validated 
instrument specific to caregivers for patients with cancer, to measure family caregiver QoL in multiple 
domains.27  It is estimated that the CarGOQoL (Appendix 31.05) will take approximately 2-4 minutes to 
complete. 
 
9.5.6 Caregiving Burden 
Caregiving burden will be measured using the Caregiver Reaction Assessment (CRA).28 It is estimated 
that this tool (Appendix 31.06) will take approximately 3-5 minutes to complete 
 
9.5.7 Self-Efficacy 
We will use the Lewis Cancer Self-Efficacy Scale (CASE) to measure caregivers’ confidence in 
managing the impact of their loved one’s illness.29  The CASE questionnaire is included as Appendix 
31.07 and will take approximately 2-4 minutes to complete. 
 
9.5.8 Perceived Coping Skills 
We will use the Measure of Current Status (MOCS) to assess caregivers’ self-perceived status on skills 
targeted by the intervention including ability to relax, recognizing stress-inducing situations, 
restructuring maladaptive thoughts, and coping.30  The MOCS is included as Appendix 31.08.  It is 
estimated that the MOCS will take approximately 2-4 minutes to complete. 
 
9.5.9 Qualitative Exit Interview 
We will use a semi-structured interview guide that will explore 1) caregiver perception of the 
acceptability and content of the intervention; and 2) caregiver perceptions of the benefits of receiving 
the intervention. Facilitators will use probes to obtain comprehensive understanding of the caregivers’ 
perspectives. The semi-structured interview guide is detailed in Appendix 31.09. The interview will last 
approximately 30 minutes. 
 
9.6 Description of Intervention 
We utilized the findings from our longitudinal and qualitative studies and a thorough review of the 
literature to identify the necessary components of our planned caregiver intervention. The preliminary 
content includes three essential components: 1) a psychoeducational component to address preparedness, 
manage expectations, and develop caregiving skills; 2) a psychosocial component focusing on coping 
strategies, mindfulness, and facilitating acceptance while living with uncertainty; and 3) a self-care 

component to promote caregiver health and well-being. We anticipate that the psychological 
intervention will consist of six individual sessions (45 minutes each), which will provide sufficient dose 
to promote effective coping and reduce caregiving burden. Whenever possible, we will coordinate 
sessions with hospital and clinic visits or conduct them via phone or video conference (using a HIPAA-
compliant video platform provided by MGH TeleHealth) to minimize participant burden and facilitate 
adherence. The intervention will be delivered by a social worker or psychologist in the MGH Cancer 
Center, specifically trained on the intervention content and delivery. Interventionists may contact 
caregivers directly via text message, phone call, or email to coordinate session scheduling only. No 
identifying information will be shared via text or email; these will be used solely for scheduling 
purposes. In the Locator Form (Appendix 31.04), participants will be asked to indicate their preferred 
method of communication (phone call, text, or email), and the study team will use this response to 
determine how to contact participants.  In this pilot study, we will enroll 25 caregivers of patients with 
malignant gliomas to assess fidelity and acceptability of the intervention. Attached as Appendix 31.15 is 
the Intervention Manual for our Psychological Intervention for Caregivers of Patients with Malignant 
Gliomas, which will be used as the basis for the intervention.  We have refined the intervention to tailor 
it to the needs specific to this population of caregivers, based on our qualitative interview data.  
 
9.7 Instrument Administration 
A member of study staff trained in qualitative interviewing will facilitate the interviews over the phone 
or in person using a semi-structured interview guide with open-ended questions and response probes 
(Appendix 31.09), and the interview will last approximately 30 minutes. All interviews will be audio-
recorded; study staff will ask for permission to turn on the audio-recorder prior to beginning each 
interview. A script for administration of the qualitative interview over the phone is included as 
Appendix 31.14. 
 
The brief enrollment survey (Appendices 31.03, 31.04) and the 7-item Generalized Anxiety Disorder 
measure (Appendix 31.01) may be completed by participants via mail correspondence, online using a 
secure website (REDCap), over the phone, or in clinic at MGH, in accordance with participant 
preferences and availability. The message templates for administration of the GAD-7 and enrollment 
survey by mail and REDCap are included as Appendices 31.11 and 31.12, respectively. A script for 
survey administration over the phone is included as Appendix 31.13. Only participants who have a 
GAD-7 score ≥5 will be registered in OnCore and complete the qualitative interview. Caregivers with 
GAD-7 scores <5 will be considered ineligible for the study. If a caregiver is ineligible based on his or 
her GAD-7 score but is still interested in the study, we will re-approach in 3 months and re-administer 
the GAD-7. 
 
10.0 Data and Specimen Banking 
N/A 
 
11.0 Data Management and Confidentiality 
11.1 Sample size and power calculations 
We will recruit and consent 25 caregivers for the open pilot. We chose the sample size of 25 caregivers 
based on the feasibility of completing the project in a timely fashion, given the rarity of this disease. It is 

expected that it will take approximately twelve to eighteen months to complete accrual for the study. 
The proposed sample size is also sufficient to provide us with preliminary data that can be utilized to 
determine the effect size and adequately power a multi-center randomized controlled trial in the 
future.54,55 
 
 
 
 
11.2 Analysis Plan 
Feasibility will be defined by rates of enrollment and participation.  We will report the proportion of 
eligible caregivers who agree to participate in the intervention and the proportion of intervention visits 
completed by each participant. Additionally, we will examine reasons for declining participation, 
incomplete session attendance, and early withdrawal from the study. The intervention will be deemed 
feasible if at least 70% (+/- 18%) of eligible caregivers are enrolled in the study and if at least 70% of 
enrolled participants complete ≥50% of the sessions.31-34 We will use descriptive statistics to summarize 
the demographic and clinical characteristics of caregivers enrolled in the study. We will audio-record 
and transcribe the individual semi-structured exit interviews and analyze qualitative data according to 
NIH Best Practices for Mixed Methods Research in the Health Sciences.35  Study staff will 
independently review the transcripts to create a thematic framework for interpretation.  Two individuals, 
including the Principal Investigator, will independently code the data to enhance validity and credibility, 
until high reliability is achieved (Kappa>0.80). The planned sample size will allow us to collect 
comprehensive feedback and ensures sufficient number of participants to achieve thematic saturation.  In 
an exploratory analysis, we will also examine changes in caregiver-reported outcomes from baseline to 
post-intervention using paired t-tests. 
 
11.3 Data Collection 
Data will be collected primarily in the form of caregiver interviews.  Interviews will be audio recorded 
on a digital recorder, and the audio files will be stored in an encrypted computer drive on the secure 
Partners network. Caregivers will complete the 7-Item Generalized Anxiety Disorder scale (GAD-7) to 
determine whether they are eligible to participate in an interview. We will also gather demographic and 
contact information about our sample via a brief enrollment survey.  Specifically, we will collect data 
on: 
 
Data 
At 
screening 
Pre-
Intervention 
Post-
Intervention 
7-Item 
Generalized 
Anxiety 
Disorder 
(GAD-7) 
X 
 
 
Demographics 
X 
 
 
Locator Form (Contact Information) 
 
 
X 
 
 
Hospital Anxiety and Depression Scale 
(HADS) 
 
X 
X 
CareGiver Oncology QoL questionnaire 
(CarGOQoL) 
 
X 
X 

Caregiver Reaction Assessment (CRA) 
 
X 
X 
Lewis Cancer Self-Efficacy Scale (CASE) 
 
X 
X 
Measure of Current Status (MOCS) 
 
X 
X 
Qualitative Exit Interview 
 
 
X 
 
To safeguard participant information and confidentiality, all data will be stored in locked cabinets in 
study staff’s offices, in password-protected computer files, and in REDCap databases, all of which are 
accessible only to trained and IRB-approved study staff. Participants' data will be identified by an ID 
number only, and a link between names and ID numbers will be kept separately under lock and key or in 
a separate password protected document accessible only by study staff. 
 
As part of the NIH data sharing directive, deidentified data from this study will be transferred to the 
PCRC De-identified Data Repository located at the University of Colorado. Any deidentified data that 
are collected and entered will remain in the PCRC Data Repository indefinitely. All future data analysis 
will be performed on de-identified data in the PCRC Data Repository. While the information and data 
resulting from this study may be presented at scientific meetings or published in a scientific journal, 
participant identities will not be revealed. Data will be presented in aggregate reports without patient-
level identifiers. 
 
Consistent with the PCRC Data Sharing Policy, the data from this study will be deidentified and will be 
transferred and stored on a server maintained by the PCRC at the University of Colorado (U of CO). U 
of CO’s Office of Information Technology (OIT) Department provides University employees with 
centralized file sharing services. Centralized file servers are Windows-based virtual systems hosted in 
OIT’s vmware server environment. These servers are proactively monitored by the automated 
monitoring system, patched on a monthly basis with latest security patches and updates, and backed up 
nightly by OIT’s Enterprise backup solution, consistent with good data storage practices. 
 
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A. This study does not involve more than Minimal Risk to subjects. 
 
 
13.0 Withdrawal of Subjects 
We do not anticipate that any research participants will be withdrawn from the study without their 
consent. If a participant requests withdrawal from the study, we will ask them if they are comfortable 
sharing the reason for withdrawal to ensure that there are no adverse events to report to the IRB. We will 
ask the study participant if they are still willing to permit the study team to continue to monitor their 
health record, but withdraw from all other study procedures.  
 
 
14.0 Risks to Subjects 
We do not anticipate that participants in the psychological intervention or qualitative interviews will 
experience any serious adverse reactions. If a participant expresses distress during the psychological 
intervention visits or exit interviews, they will be reassured by the psychologist and the research staff that 

they can stop the intervention and they need not answer any of the interview 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 oncologist will be notified. Additionally, we will offer 
participants who remain distressed an opportunity to meet with either the principal investigator (Dr. 
Deborah Forst) or a clinical psychologist (Dr. Joseph Greer, a co-investigator) to help address their 
distress. Should participants require further support, we will offer them an opportunity to meet with the 
MGH Neuro Oncology Clinic social worker for additional follow-up. 
 
 
15.0 Potential Benefits to Subjects 
Preliminary data have demonstrated that more than 50% of caregivers of patients with malignant 
gliomas have clinically significant anxiety at the time of their loved one’s diagnosis, with almost two-
thirds endorsing anxiety over their course of illness. The proposed psychological intervention aims to 
decrease anxiety and promote coping in this highly burdened caregiver population. Participation in this 
study may help to improve caregivers’ mental health by addressing their unique supportive care and 
coping needs. 
 
 
16.0 Vulnerable Populations 
We plan to include pregnant women in this study. As this is a psychological and behavioral study only, 
additional safeguards are not needed for this population. No other vulnerable populations will be 
included in this study. 
 
17.0 Community-Based Participatory Research 
N/A 
18.0 Sharing of Results with Subjects 
We will provide the research team contact information to each participant and encourage them to contact 
us if they would like to receive updates and information on the research findings.  
 
19.0 Setting 
Study staff will review the outpatient clinic schedule for the Yawkey 9E Brain Tumor Clinic to identify 
patients with malignant gliomas. Staff will approach the caregivers of these patients in clinic to obtain 
consent and administer surveys and questionnaires. Intervention sessions will be administered in person 
here at MGH. Qualitative exit interviews may be administered in person at MGH or over the phone. 
 
20.0 Resources Available 
20.1 Team Qualification and Oversight 
The overall PI of the project (Dr. Forst) is responsible for full oversight of the project. Dr. Forst 
currently has 60% of her time protected to conduct research activities. She will be meeting with study 
staff on weekly basis (and more often as urgent issues arise) to ensure the study process is being 
followed accurately and to address potential challenges or issues as they may arise. Dr. Forst is a 
member of the MGH Cancer Outcomes Research Program (CORe).  CORe has extensive experience 
conducting supportive care intervention studies in oncology and has the necessary expertise to ensure 
the success of the proposed project. Research coordinators, all of whom previously have received CITI 
and consent training, will be provided study-specific recruitment training. 

20.2 Other Resources 
There are approximately 100 new malignant glioma patients in the Yawkey 9E Brain Tumor Clinic each 
year, so we will need to recruit about 33% of these patients’ caregivers in order to reach our target 
accrual of 25 caregivers over the course of 18 months. 
 
See Section 14.0 for a description of the resources available to subjects given possible consequences of 
the research. 
 
21.0 Prior Approvals 
We will obtain IRB approval prior to initiating any study procedures. 
 
22.0 Recruitment Methods 
Study staff will review the outpatient clinic schedule for the Yawkey 9E Brain Tumor Clinic to identify 
patients with malignant gliomas.  To facilitate identification of potential participants and assess 
eligibility, study staff will review minimum necessary medical record data via a HIPAA waiver. This 
will ensure that caregivers are potentially eligible to participate in the study prior to contacting them to 
obtain informed consent. Prior to contacting potential participants identified via screening, the patient’s 
primary treating oncologist will be contacted by email to inform them that we plan to approach the 
patient’s caregiver for study participation and to inquire about any concerns regarding study 
participation. The email template for obtaining permission from oncologists is included as Appendix 
31.10. If clinicians have specific concerns about the appropriateness of enrolling a particular caregiver, 
we will not contact that caregiver. 
 
A member of study staff (e.g. PI, Research Assistants) will obtain informed consent in-person prior to 
initiating any study measures. Research assistants, all of whom previously have received CITI and consent 
training, will be provided study-specific recruitment training. Caregivers who would like more time to 
consider participation at in-clinic approach are able to take the consent forms home with them to review. 
Caregivers will be provided with study staff contact information if any questions or concerns regarding 
the research arise.  
 
Study staff will register eligible participants in the Clinical Trials Management System (CTMS) OnCore 
as required by DF/HCC SOP REGIST-101 after the participant completes the brief enrollment survey. 
Caregivers who report GAD-7 scores <5 will be considered ineligible for the study and will not be 
registered in OnCore. Caregivers who do not complete the brief enrollment survey will not be registered 
in OnCore.  
 
23.0 Local Number of Subjects 
A total of 25 subjects (excluding screen failures) will be accrued locally. We expect more than 50% to 
demonstrate at least mild anxiety (GAD-7 score of 5 or greater) so total accrual of no more than 50 
caregivers including screen failures should be necessary. 
 
24.0 Provisions to Protect the Privacy Interests of Subjects 
To safeguard participant information and confidentiality, all data will be stored in locked cabinets in 
study staff’s offices, in password-protected computer files, and in REDCap databases, all of which are 
accessible only to trained and IRB-approved study staff. Participants' data will be identified by an ID 

number only, and a link between names and ID numbers will be kept separately under lock and key or in 
a separate password protected document accessible only by study staff. 
 
25.0 Compensation for Research-Related Injury 
We do not anticipate any research-related injury due to involvement in this supportive care intervention. 
 
26.0 Economic Burden to Subjects 
There will be no financial burden on study participants. 
 
27.0 Consent Process 
As stated previously, a member of study staff (e.g. PI, Research Assistant) will obtain informed consent 
in-person during clinic appointments or infusion prior to initiating any study measures. Research 
assistants, all of whom previously have received CITI and consent training, will be provided study-specific 
recruitment training. Caregivers who would like more time to consider participation at in-clinic approach 
are able to take the consent forms home with them to review. Caregivers will be provided with study staff 
contact information if any questions or concerns regarding the research arise.  
We will follow all the requirements of SOP: Informed Consent Process (CON-100) in obtaining 
informed consent for study participants. 
 
 
28.0 Process to Document Consent in Writing 
As stated previously, all caregivers participating in the study will provide written informed consent. 
 
29.0 Drugs or Devices 
N/A 
 
30.0 References 
 
1. Ostrom QT, Gittleman H, Xu J, et al: CBTRUS Statistical Report: Primary Brain and Other Central 
Nervous System Tumors Diagnosed in the United States in 2009-2013. Neuro Oncol 18:v1-v75, 2016 
2. Sizoo EM, Pasman HR, Dirven L, et al: The end-of-life phase of high-grade glioma patients: a 
systematic review. Support Care Cancer 22:847-57, 2014 
3. Achey RL, Khanna V, Ostrom QT, et al: Incidence and survival trends in oligodendrogliomas and 
anaplastic oligodendrogliomas in the United States from 2000 to 2013: a CBTRUS Report. J 
Neurooncol 133:17-25, 2017 
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temozolomide for glioblastoma. N Engl J Med 352:987-96, 2005 
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health. Psychooncology 7:3-13, 1998 
6. Schulz R, Sherwood PR: Physical and mental health effects of family caregiving. Am J Nurs 108:23-
7; quiz 27, 2008 

7. Kim Y, Given BA: Quality of life of family caregivers of cancer survivors: across the trajectory of the 
illness. Cancer 112:2556-68, 2008 
8. Schulz R, Beach SR: Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. 
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daughters and their mothers with cancer. Psychooncology 17:1129-36, 2008 
10. Kim Y, Spillers RL, Hall DL: Quality of life of family caregivers 5 years after a relative's cancer 
diagnosis: follow-up of the national quality of life survey for caregivers. Psychooncology 21:273-81, 
2012 
11. Shaffer KM, Kim Y, Carver CS, et al: Depressive symptoms predict cancer caregivers' physical 
health decline. Cancer 123:4277-4285, 2017 
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patients with glioblastoma: A preliminary report. Cancer 123:832-840, 2017 
13. Yang HC, Schuler TA: Marital quality and survivorship: slowed recovery for breast cancer patients 
in distressed relationships. Cancer 115:217-28, 2009 
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survival and family caregiver presence and burden. Cancer Med 5:853-62, 2016 
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primary malignant brain tumor. Support Care Cancer 25:245-253, 2017 
16. Aoun SM, Deas K, Howting D, et al: Exploring the Support Needs of Family Caregivers of Patients 
with Brain Cancer Using the CSNAT: A Comparative Study with Other Cancer Groups. PLoS One 
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17. Sherwood PR, Cwiklik M, Donovan HS: Neuro-oncology family caregiving: review and directions 
for future research. CNS Oncol 5:41-8, 2016 
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Glioma: A Qualitative Study of Their Lived Experience and Needs Related to Professional Care. Cancer 
Nurs 38:406-13, 2015 
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22. 
Spitzer RL, Kroenke K, Williams JB, et al: A brief measure for assessing generalized anxiety 
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Kroenke K, Theobald D, Wu J, et al: The association of depression and pain with health-related 
quality of life, disability, and health care use in cancer patients. J Pain Symptom Manage 40:327-341, 
2010 
24. 
Löwe B, Decker O, Müller S, et al: Validation and standardization of the Generalized Anxiety 
Disorder Screener (GAD-7) in the general population. Med Care 46:266-274, 2008 
25. 
Andersen BL, DeRubeis RJ, Berman BS, et al: Screening, assessment, and care of anxiety and 
depressive symptoms in adults with cancer: an American Society of Clinical Oncology guideline 
adaptation. J Clin Oncol 32:1605-1619, 2014 
 
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1983;67(6):361-70. 
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(CarGOQoL): development and validation of an instrument to measure the quality of life of the 
caregivers of patients with cancer. Eur J Cancer 48:904-11, 2012 
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persons with chronic physical and mental impairments. Res Nurs Health 15:271-83, 1992 
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National Institutes of Health, 1996 
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http://www.psy.miami.edu/faculty/ccarver/sclMOCS.html 
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34. Schoenfeld D: Statistical considerations for pilot studies. Int J Radiat Oncol Biol Phys 6:371-4, 1980 
35. Miles M HA: Qualitative data analysis: a sourcebook of new methods. Beverly Hills, CA, Sage 
Publications, 1984 
 
 
 
 
 

 
 
 
 
 
 
31.0 Appendix 
 
31.01 7-Item Generalized Anxiety Disorder (GAD-7) 
 
GAD-7 
 
Over the last 2 weeks, how often have you been 
bothered by any of 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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
31.02 Hospital Anxiety and Depression Scale (HADS) 
 
INSTRUCTIONS: Read each item and please select the answer which comes closest to how you have 
been feeling, on the average, IN THE PAST WEEK: 
 
 
1. I feel tense or "wound up."  
a. Most of the time 
b. A lot of the time 
c. From time to time, occasionally 
d. Not at all 
 
3. I get a sort of frightened feeling as if 
something awful is about to happen.  
a. Very definitely and quite badly 
b. Yes, but not too badly 
c. A little, but it doesn't worry me 
d. Not at all 
 
5. Worrying thoughts go through my mind.  
a. A great deal of the time 
b. A lot of the time 
c. From time to time but not too often 
d. Only occasionally 
 
7. I can sit at ease and feel relaxed. 
a. Definitely 
b. Usually 
c. Not often 
d. Not at all 
2. I still enjoy the things I used to enjoy. 
a. Definitely as much 
b. Not quite as much 
c. Only a little 
d. Hardly at all 
 
4. I can laugh and see the funny side of 
things. 
a. As much as I always could 
b. Not quite so much now 
c. Definitely not so much now 
d. Not at all 
 
6. I feel cheerful.  
a. Not at all 
b. Not often 
c. Sometimes 
d. Most of the time 
 
8. I feel as if I am slowed down.  
a. Nearly all the time 
b. Very often 
c. Sometimes 
d. Not at all 

9. I get a sort of frightened feeling like 
"butterflies" in the stomach. 
a. Not at all 
b. Occasionally 
c. Quite often 
d. Very often 
 
11. I feel restless as if I have to be on the 
move.  
a. Very much indeed 
b. Quite a lot 
c. Not very much 
d. Not at all 
 
13. I get sudden feelings of panic.  
a. Very often indeed 
b. Quite often 
c. Not very often 
d. Not at all 
10. I have lost interest in my appearance.  
a. Definitely 
b. I don't take so much care as I should 
c. I may not take quite as much care 
d. I take just as much care as ever 
 
 
12. I look forward with enjoyment to things. 
a. As much as I ever did 
b. Rather less than I used to 
c. Definitely less than I used to 
d. Hardly at all 
 
14. I can enjoy a good book or radio or TV 
program. 
a. Often 
b. Sometimes 
c. Not often 
d. Very seldom

31.03 Brief Demographic Survey 
 
1. Gender 
 Man 
 Woman 
 Specify: ______________________ 
 
2.  Relationship to patient 
 Married or living as if married 
 Non-cohabiting relationship 
 Divorced/Separated 
 Child (daughter or son) 
 Parent (mother or father) 
 Sibling (brother or sister) 
 Friend 
 Other (please specify)______________ 
 
3. Race 
 American Indian or Alaskan native 
 Asian 
 African American or Black 
 Hispanic 
 Native Hawaiian or other Pacific Islander 
 White 
 Other (please specify) ______________ 
 
4.   Ethnicity 
 Hispanic or Latino 
 Not Hispanic or Latino 
 
5. Religion 
 Catholic 
 Protestant 
 Jewish 
 Muslim 
 None 
 Other (please specify)_______________ 
 
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. Relationship status 
 Married or living with someone as if 
married  
 Non-cohabiting relationship  
 Single, never married 
 Divorced or separated 
 Loss of long-term partner/widowed 
 Other (please specify) _______________ 
 
8. Please indicate who (if anyone) you live with 
(you may check more than one box) 
 Self only 
 Partner/Spouse 
 Roommate/Friend 
 Dependent Children 
If yes, specify number(s) _____________ 
If yes, specify age(s) ________________ 
 Group home/Residential 
 Independent Child 
 Dependent Adult 
 Parent 
 Other (please specify) _______________ 
 
9. Employment Status: (you may check more 
than one box) 
 Full time work 
 Part time work 
 Retired 
 Paid leave 
 Unpaid leave 
 Other (please specify) _______________ 
 
10. What is your annual combined household 
income? 
 Less than $25,000 
 $25,000 – 50,000 
 $51,000 -100,000 
 $101,000 – 150,000 
 Greater than $150,000 
 
11. Please indicate how long you have known  
 
the patient: _________ years 
 
12. Do you live in the same residence as the 
patient? 
 Yes 
 No 

 
31.04 Locator Form 
 
 
 
Locator Form 
 
 
 
 
Please complete the following legibly. 
 
 
Full name: _______________________________________________________________________ 
 
 
 
Address: ________________________________________________________________________ 
________________________________________________________________________ 
________________________________________________________________________ 
 
 
 
Cell phone:  ______________________________________________________________________ 
Home phone: _____________________________________________________________________ 
Work phone: ______________________________________________________________________ 
 
 
 
Email address: ____________________________________________________________________ 
 
 
What is your preferred contact method for scheduling? (circle one): phone call / text message / e-mail  
 
 
 
Date of birth (month/day/year): _______ / _______ / ____________  
 
 

 
31.05 Caregiver Oncology Quality of Life  
 
Concerning the person you help, have you:  
1. Been worried, anxious? 
 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
2. Been sad, depressed? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
3. Felt emotionally tired, worn out? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
4. Been stressed? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
5. Felt a lack of freedom? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
6. Been bothered by the feeling of being confined? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
7. Been bothered by the fact that your life was 
entirely devoted to the care recipient? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
8. Been embarrassed to be the only person to 
provide assistance? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
9. Been satisfied with information given by health 
care providers (doctors, nurses…)? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
 
10. Been reassured by the health care providers 
(doctors, nurses…)? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 

11. Felt that your role as caregiver was recognized 
by health care providers (doctors, nurses…)? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
12. Had financial difficulties? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
13. Had other difficulties (lodging, 
transportation…)? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
14. Encountered difficulties in the administrative 
process (health insurance paperwork and other 
paperwork related to the cancer illness)? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
15. Experienced feelings of guilt? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
16. Been bothered by a feeling of helplessness 
against the disease? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
17. Felt a feeling of injustice, anger, or rebellion? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
18. Had sleeping difficulties? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often/ A lot 
 Always / Very Much 
 
19. Had problems with your appetite? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
20. Been physically tired, worn out? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
 
 
 
21. Had the impression that your health was fragile? 

 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
22. Felt you made a difference for the person you 
are helping? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
23. Felt useful? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
24. Could rest, relax?? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
25. Could take care of yourself, pay attention to 
your own health? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
 
 
26. Been assisted, supported, understood by your 
family? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
27. Been assisted, supported, understood by your 
friends? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
28. Had difficulties in your intimate, emotional life? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Much 
 
29. Had a satisfying love and sexual life? 
 Never/ Not at all 
 Rarely / a little bit 
 Sometimes / Somewhat 
 Often / A lot 
 Always / Very Mu

 
 
 
31.06 Caregiver Reaction Assessment 
 
Please answer the following items with regards to caring for your loved one during their illness.  
 
 
Strongly 
agree 
Agree Neither agree 
or disagree 
Disagree Strongly 
disagree 
I feel privileged to care for my loved one 
 
 
 
 
 
Others have dumped caring for my loved 
one onto me 
 
 
 
 
 
My financial resources are adequate to pay 
for things that are required for caregiving 
 
 
 
 
 
My activities are centered around care for 
my loved one 
 
 
 
 
 
Since caring for my loved one, it seems 
like I am tired all the time 
 
 
 
 
 
It is very difficult to get help from my 
family in taking care of my loved one 
 
 
 
 
 
I resent having to take care of my loved 
one 
 
 
 
 
 
I have to stop in the middle of work 
 
 
 
 
 
I really want to care for my loved one 
 
 
 
 
 
My health has gotten worse since I have 
been caring for my loved one 
 
 
 
 
 
I visit family and friends less since I have 
been caring for my loved one 
 
 
 
 
 
I will never be able to do enough 
caregiving to repay my loved one 
 
 
 
 
 
My family works together at caring for my 
loved one 
 
 
 
 
 
I have eliminated things from my schedule 
since caring for my loved one 
 
 
 
 
 
I have enough physical strength to care for 
my loved one 
 
 
 
 
 
Since caring for my loved one, I feel my 
family has abandoned me 
 
 
 
 
 
Caring for my loved one makes me feel 
good 
 
 
 
 
 
The constant interruptions make it difficult 
to find time for relaxation 
 
 
 
 
 
I am healthy enough to care for my loved 
one 
 
 
 
 
 
Caring for my loved one is important to 
me 
 
 
 
 
 
Caring for my loved one has put a 
financial strain on the family 
 
 
 
 
 
My family (brothers, sisters, children) left 
me alone to care for my loved one 
 
 
 
 
 
I enjoy caring for my loved one 
 
 
 
 
 

 
 
It is difficult to pay for my loved one’s 
health needs and services 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
31.07 Lewis Cancer Self-Efficacy Scale 
 
CASE: Cancer Self-efficacy Scale 

 
 
Patient Version 
Instructions: 
 
We would like to know how confident or sure you feel about some of these areas that arise when you are going 
through the experience of caring for a loved one with cancer.  Please rate your degree of confidence for each 
sentence by circling a number from 0 to 10 using the scale shown.  When you choose a higher number, you are 
telling us you are more confident. 
 
 
Rate the confidence you feel TODAY 
 
 
Not at all 
confident 
Very 
confident 
1. I am confident that I can use information and 
resources to cope with the demands of my loved 
one’s illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
2. I am confident that I can call on my inner 
strengths to pull myself through my loved one’s 
illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
3. I am confident that I have what it takes to help my 
family through my loved one’s illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
4. I am confident that I can maintain close 
communication with my loved one about their 
illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
5. I am confident that I can take the necessary steps 
to work through the demands of my loved one’s 
illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
6. I am confident that I have what it takes to help my 
family handle this illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
7. I am confident that I can handle the challenges of 
my loved one’s illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
8. I am confident that I have ways to manage the 
uncertainty brought on by my loved one’s illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
9. I am confident that I can manage difficult 
interactions with my loved one’s doctors, nurses, 
and other health care providers. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
10. I am confident that I am can put my loved one’s 
illness into proper perspective in my life. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
 
Rate the confidence you feel TODAY 
 
 
Not at all 
 
Very 

 
 
 
confident 
confident 
11. I am confident that I have the ability emotionally 
to help my family work through the issues caused 
by my loved one’s illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
12. I am confident that I can deal with the physical 
changes caused by my loved one’s illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
13. I am confident that I can manage what is being 
asked of me despite this illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
14. I am confident that I have the skills to deal with 
the pressures the illness is causing in my close 
relationships. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
15. I am confident that I have ways to manage the 
side effects caused by treating the cancer. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
16. I am confident that I can keep a positive outlook 
in spite of the demands of this illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
17. I am confident that I have ways to manage the 
stress associated with this illness. 
 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Copyright F.M. Lewis, 1996 
 
 
 
 
 
 
31.08 Measure of Current Status 
 

 
 
People have different levels of various skills for responding to the challenges and demands of everyday 
life.  The following items list several things that people are able to do--to a greater or lesser degree--to deal with 
daily stresses.  For each item, indicate how well you currently can do what it describes.  Please don't indicate 
what you think you should be able to do, or what you wish you could do.  Be as accurate as you can in reporting 
your degree of confidence about being able to do each of these things.  Choose from the following responses: 
 
 
I 
cannot 
do 
this at 
all 
I can 
do 
this 
just 
a 
little 
bit 
I can do 
this a 
medium 
amount 
I can 
do 
this 
pretty 
well 
I can do 
this 
extremely 
well 
I am able to use muscle relaxation 
techniques to reduce any tension I 
experience 
0 
1 
2 
3 
4 
I become aware of any tightness in my 
body as soon as it develops 
0 
1 
2 
3 
4 
I can clearly express my needs to other 
people who are important to me 
0 
1 
2 
3 
4 
I can easily stop and re-examine my 
thoughts to gain a new perspective 
0 
1 
2 
3 
4 
It's easy for me to decide how to cope 
with whatever problems arise 
0 
1 
2 
3 
4 
I can easily recognize situations that make 
me feel stressed or upset 
0 
1 
2 
3 
4 
When problems arise I know how to cope 
with them 
0 
1 
2 
3 
4 
I notice right away whenever my body is 
becoming tense 
0 
1 
2 
3 
4 
It's easy for me to go to people in my life 
for help or support when I need it 
0 
1 
2 
3 
4 
I am able to use mental imagery to reduce 
any tension I experience 
0 
1 
2 
3 
4 
I am confident about being able to choose 
the best coping responses for hard 
situations 
0 
1 
2 
3 
4 
I can come up with emotionally balanced 
thoughts even during negative times 
0 
1 
2 
3 
4 
I can ask people in my life for support or 
assistance whenever I need it 
0 
1 
2 
3 
4 
 
 
 
 
31.09 Qualitative Exit Interview 
 
INTRODUCTION 
 

 
 
You recently took part in a study that was designed to help caregivers of with brain tumors cope most 
effectively with their loved ones’ illness. We are now interested to know about your satisfaction with different 
aspects of this research study so that we continue to shape how to provide it to patients. 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 medical care. 
 
First, I am going to ask you some questions about the timing of the sessions you had and how they were 
delivered. 
 
1. This study was scheduled to start within 6 months after your loved one’s diagnosis. How do you feel about 
the timing of the program? 
 
A. Right time 
Additional Comments: 
B. 
Too early in treatment 
C. 
Too late in treatment 
 
 
2. This study was scheduled to continue for 6 weeks. How do you feel about the length of the program? 
 
A. Right time 
Additional Comments: 
B. 
Too short 
C. 
Too long 
 
3. What prevented you from attending the intervention sessions? What would help you attend more of these 
sessions? 
 
 
4. The research study was designed so that sessions can be scheduled over the phone or through telemedicine 
(videoconference) when in-person visits were not possible. How do you feel about the phone or video 
sessions?  
 
A. 
Great 
Additional Comments: 
B. 
In-person was better 
C. 
Not sure 
 
Additional Probe: Would you have preferred all sessions to be delivered over the telephone or telemedicine 
for convenience? 
 
 
5. How do you feel about the total number of visits included in this research study (six visits total)?  
 
A. 
Right amount 
Additional Comments: 

 
 
B. 
Too few 
C. 
Too many 
 
6. How do you feel about the amount of time each session lasted?  
 
A. 
Right amount 
Additional Comments: 
B. 
Too short 
C. 
Too long 
 
Now I am going to ask you some questions about the material covered in your visits. 
 
7. During these sessions, you may have learned about strategies to help you cope most effectively with your 
loved ones’ illness.  How helpful did you find these strategies? 
 
A. 
Helpful 
Additional Comments: 
B. 
Not helpful 
C. 
Not sure 
 
Additional Probe: The interviewer can remind the caregiver about specific strategies such as acceptance, 
mindfulness, problem-solving, self-care, communication techniques, etc. Also ask which of these strategies 
was the most helpful 
 
 
8. Since going to the study visits, how often have you used any of these strategies on your own? 
 
A. 
Daily 
Additional Comments: 
B. 
Few times/ week 
C. 
Once or twice 
D. 
Never 
 
 
 
 
9. During these sessions, you may have learned about skills or strategies that would help you gain more 
confidence in your ability to care for your loved one. How helpful was it to learn about these skills or 
strategies?  
 
A. 
Helpful 
Additional Comments: 
B. 
Not helpful 

 
 
C. 
Not sure 
 
Additional probe: Which of these strategies was the most helpful? 
 
10. Since going to the study visits, how often have you used any of the skills or strategies on your own?  
 
A. 
Daily 
Additional Comments: 
B. 
Few times/ week 
C. 
Once or twice 
D. 
Never 
 
11. During these sessions, you may have learned about skills or strategies that would help take better care of 
yourself during your loved ones’ illness. How helpful was it to learn about these skills or strategies?  
 
A. 
Helpful 
Additional Comments: 
B. 
Not helpful 
C. 
Not sure 
 
Additional probe: Which of these strategies was the most helpful? 
 
12. Since going to the study visits, how often have you used any of the skills or strategies on your own?  
 
A. 
Daily 
Additional Comments: 
B. 
Few times/ week 
C. 
Once or twice 
D. 
Never 
 
 
 
 
 
13. During these sessions, you may have learned about skills or strategies that would help communicate more 
effectively with your loved one. How helpful was it to learn about these skills or strategies?  
 
A. 
Helpful 
Additional Comments: 
B. 
Not helpful 
C. 
Not sure 
 
 
 
 

 
 
Additional probe: Which of these strategies was the most helpful? 
 
 
 
14. Since going to the study visits, how often have you used any of the skills or strategies on your own?  
 
A. 
Daily 
Additional Comments: 
B. 
Few times/ week 
C. 
Once or twice 
D. 
Never 
 
 
 
15. Is there anything else that you found helpful about this program?  
 
 
16. Is there anything else that you found not helpful about this program?  
 
 
17. What other kinds of programs focusing on improving your well-being (if any) would have been helpful soon 
after to your loved one’s diagnosis?  
 
 
18. What other kinds of programs focusing on improving your well-being (if any) would have been helpful later 
on following your loved one’s diagnosis?  
 
 
19. What other kinds of programs focusing on improving your well-being (if any) would be helpful to you now?  
 
 
 
 
 
 
20. People learn information in different ways. What would you prefer in terms of how the intervention is 
administered? 
 
A. 
One-on-one visit with a clinician 
Additional Comments: 
B. 
Reading information from a pamphlet 
C. 
Watching an informational video 
D. 
Telephone contact with a clinician 
 
 
 
F. 
Getting information from a mobile app 
 

 
 
 
G. 
Video (skype-like) sessions 
 
H. 
Group-based sessions with other 
caregivers 
 
 
 
21. Is there anything else that you would like to add that we have not discussed? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
31.10 Oncologist Permission to Approach Email Template 
 
Dear [Oncologist], 
 
The caregiver of your patient, [Patient Name] (MRN), is potentially eligible for Dr. Forst’s pilot study of a 
psychological intervention aimed at decreasing anxiety and promoting coping in caregivers of patients with 
malignant gliomas. Would it be alright if I approached [patient] and his/her caregiver, if present, before after 
his/her appointment with [provider] on [date] at [time] to introduce the study and see if they’re interested in 
participating?  
 
Thank you!  
[Staff Name] 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
31.11 Letter Template for At-Home Survey Completion by Mail 
 
Dear [Caregiver], 
 
Thank you so much again for your interest in our study assessing the effectiveness of a psychological 
intervention for caregivers of loved ones with malignant gliomas. The attached questionnaires will help us 
determine whether or not you are eligible to participate in the study. Once you’ve completed them, please mail 
them back in the enclosed prepaid and addressed envelope. Don’t hesitate to reach out if you have any questions 
about questionnaires or the study! 
 
Thank you, 
[Staff Name] 
[Staff Phone] 
[Staff email] 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
31.12 Template for REDCap Survey Invitation 
 
Dear [Caregiver], 
 
Thank you so much again for your interest in our study assessing the effectiveness of a psychological 
intervention for caregivers of loved ones with malignant gliomas. Please find below a link to some 
questionnaires which will help us determine whether or not you are eligible to participate in the study. Please 
don’t hesitate to reach out if you have any questions about questionnaires or the study! 
 
Thank you, 
[Staff Name] 
[Staff Phone] 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
31.13 Phone Script for Survey Administration 
 
Hello, this is [staff name] calling from Massachusetts General Hospital. How are you today? 
 
Thank you so much for your interest in our study assessing the effectiveness of a psychological intervention for 
caregivers of loved ones with malignant gliomas. As I mentioned when we spoke in clinic, we have a few 
surveys which will help us to determine whether or not you’re eligible for the study. Do you have about 10 
minutes now to complete them over the phone with me? 
 
(If yes): Complete GAD-7 (Appendix 31.01) with caregiver and score immediately. 
 
If eligible (GAD-7 score ≥5): Continue to Demographics Survey (Appendix 31.03) and Locator Form 
(Appendix 31.04) 
When complete: Thank you so much for your time today! We will be in touch with you soon to 
begin scheduling your sessions with a psychologist or social worker. If you have any questions, 
please don’t hesitate to reach out. I can be reached at [staff contact information]. I hope you have 
a great day! 
 
If ineligible (GAD-7 score <5): Thank you so much for your time and interest! Unfortunately, based on 
your answers to this questionnaire, you are not eligible for the study at this time. However, if you’d like 
any more information about support for caregivers, we’d be happy to reach out to your loved one’s 

 
 
oncologist to have them refer you to the Brain Tumor Clinic social worker. Is this something you would 
be interested in? 
(If yes): Okay, I will go ahead and contact [oncologist’s name] about this for you! 
(If no): Okay! You can always talk to [oncologist’s name] if you feel like this might be a helpful 
resource later. 
 
Thank you so much for your time today! We really appreciate your interest in the study and are 
sorry that you’re not eligible at this time. Please don’t hesitate to reach out if you have any 
questions. I can be reached at [staff contact information]. I hope you have a great day! 
 
(If no): When would be a more convenient time for me to call you? 
When alternate call is scheduled: Thank you so much! I look forward to speaking with you on [date] at 
[time]. Have a great day! 
 
Voicemail script: 
Hello, this is [name] calling from Massachusetts General Hospital. I’m reaching out to get in touch with 
[caregiver name] regarding a research study that he/she was interested in participating in. Please give me a call 
back when you have a chance. I can be reached at [staff contact information]. Thank you! 
 
 
 
 
 
 
 
 
 
 
31.14 Phone Script for Exit Interview 
Hello, this is [staff name] calling from Massachusetts General Hospital. How are you today? 
You recently took part in a study that was designed to help caregivers of patients with brain tumors cope most 
effectively with their loved ones’ illness. We are now interested in asking you some questions about your 
satisfaction with various parts of this study so that we can continue to improve it. This interview will take 
approximately 30 minutes. Is this still a convenient time for you?  
(If yes): Proceed to the Interview Guide (Appendix 31.09) 
(If no): Would it be okay if I gave you a call at another time? Select a different time for the interview. 
 
Voicemail script: 
Hello, this is [name] calling from Massachusetts General Hospital. I’m reaching out to get in touch with 
[caregiver name] regarding a research study that he/she has been participating in. Please give me a call back 
when you have a chance. I can be reached at [staff contact information]. Thank you! 
 
 
 
 
 
 

 
 
 
 
31.15 Caregiver Intervention Manual for Psychological Intervention for Caregivers of Patients with 
Malignant Gliomas 
 
Caregiver manual provided as separate attachment.