Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
Phase: NA
Conditions: Colo-rectal Cancer
Sponsor: Roswell Park Cancer Institute

Document Coversheet 
 
 Study Title:  Problem Solving Skills Training in Adult Cancer Survivors: Bright 
IDEAS-AC 
 
 
Institution/Site:  
Roswell Park Comprehensive Cancer Center 
Document (Approval/Update) Date: 
 07/15/2021 
NCT Number: 
NCT03567850 
IRB Number 
I 65518 
 
 

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PROTOCOL TITLE: 
Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
PROTOCOL NUMBER: 
I 65518
PRINCIPAL INVESTIGATOR:
Ekaterina I. Noyes, PhD, MPH
Professor and Director
Division of Health Services Policy and Practice
Department of Epidemiology and Environmental Health
School of Public Health and Health Professions
University of Buffalo
270C Farber Hall
Buffalo, NY
Tel:     716.829.5386
Email: enoyes@buffalo.edu
VERSION NUMBER: 
INITIAL: DATE: 
03/22/2018
AMENDMENT #1: 072618
AMENDMENT #2: 010719
AMENDMENT #3: 041519
AMENDMENT #4: 071919
AMENDMENT #5: 080520
AMENDMENT #6: 102320
AMENDMENT #7: 060721
Confidentiality Statement
Any and all information presented in this document shall be treated as confidential and shall 
remain the exclusive property of the party(ies) mentioned above (Roswell Park Cancer Institute 
Corporation d/b/a Roswell Park Comprehensive Cancer Center). The use of such confidential 
information must be restricted to the recipient for the agreed purpose and must not be disclosed, 
published, or otherwise communicated to any unauthorized persons, for any reason, in any form 
whatsoever without the prior written consent of the party(ies) above.
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Table of Contents
1.0
Objectives .............................................................................................................................3
2.0
Background...........................................................................................................................4
3.0
Inclusion and Exclusion Criteria ..........................................................................................6
4.0
Local and Study-Wide Number of Subjects .........................................................................9
5.0
Local and Study-Wide Recruitment Methods ......................................................................9
6.0
Multi-Site Research ............................................................................................................10
7.0
Study Timelines..................................................................................................................10
8.0
Study Endpoints..................................................................................................................11
9.0
Design.................................................................................................................................12
10.0
Treatment............................................................................................................................14
11.0
Procedures Involved ...........................................................................................................14
12.0
Withdrawal of Subjects.......................................................................................................16
13.0
Risks to Subjects.................................................................................................................16
14.0
Potential Benefits to Subjects .............................................................................................17
15.0
Data and Specimen Banking...............................................................................................17
16.0
Measurement of Effect .......................................................................................................17
17.0
Safety Evaluation................................................................................................................17
18.0
Data Management and Confidentiality...............................................................................17
19.0
Statistical Plan ....................................................................................................................18
20.0
Provisions to Monitor the Data to Ensure the Safety of Subjects.......................................18
21.0
Vulnerable Populations.......................................................................................................18
22.0
Community-Based Participatory Research.........................................................................18
23.0
Sharing of Results with Subjects ........................................................................................19
24.0
Setting.................................................................................................................................19
25.0
Provisions to Protect the Privacy Interests of Subjects ......................................................19
26.0
Resources Available ...........................................................................................................20
27.0
Prior Approvals...................................................................................................................29
28.0
Compensation for Research-Related Injury........................................................................29
29.0
Economic Burden to Subjects.............................................................................................29
30.0
Consent Process..................................................................................................................29
31.0
Process to Document Consent in Writing...........................................................................30
32.0
Drugs or Devices ................................................................................................................30
33.0
References...........................................................................................................................31
34.0
Appendices/Supplements....................................................................................................35
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1.0
Objectives
1.1 
 The aim of this 2-year study will assess the acceptability and feasibility of offering 
Problem Solving Skills Therapy (PSST) to cancer survivors and their caregivers focusing 
on the highest risk patients with distress. We will recruit 50 adults with non-terminal 
colorectal (CRC), breast, bladder or prostate cancer who are about to complete their 
adjuvant therapy or who had a survivorship care appointment and discussion about their 
SCP, and who scored 2 or higher on the NCCN Distress scale. We will use stratified 
randomization to assign them to “care as usual” (CAU) vs. a 3-month PSST intervention. 
We will evaluate the feasibility of including caregivers in the program by encouraging 
patients to bring their caregivers/significant others to their appointments. We will 
determine the number/proportion of patients who identify and bring a caregiver and 
describe the patients’ willingness and ability to do so. This study’s specific aims (SA) 
and hypotheses (H) are:  
SA1: To adapt the previously validated PSST to adult cancer patients and their 
caregivers, Bright IDEAS-AC. Following the NCI Guidelines for Choosing and Adapting 
Research-Tested Intervention Programs (RTIPs),1,2 we will revise the program materials 
and training protocol and pilot the adapted products and processes with 5 adult cancer 
survivors and/or their caregivers.
SA2: Using established framework for future implementation, determine acceptability of 
PSST in cancer survivors. The 4 acceptability objectives of the Bright IDEAS-AC Study 
are: (1) minimize burden of patient-reported data collection; (2) maximize compliance 
with 8-session SCP-specific PSST intervention; (3) minimize barriers to consistent 
participation of supportive others (SO) in PSST; and (4) estimate recruitment rates for a 
future trial. We will collect patient self-reported data about problem solving skills (SPSI-
R), physical health (pain, fatigue, bowel and bladder function (FACT-C, B, BI or P)), and 
behavioral health (depression and anxiety). We will also assess patient utilization of 
health services such as hospital and ED admissions.
SA3:  Determine a) feasibility and b) sustainability of Bright IDEAS as a clinically 
adopted intervention for adult cancer survivors using the PRISM framework, and 
feasibility of recruiting adult cancer survivors’ caregivers for inclusion in the Bright 
IDEAS intervention.  
1.2 
H1: At least 70% of contacted patients will enroll in the study.
H2: At least 80% of patients will complete 80% of PSST sessions after randomization. 
H3: At least 50% of patients will identify the burden of PSST training as < 3 on a 5-item 
Likert scale.
H4: At least 50% of patients with cancer will identify a significant other to join them in 
PSST training.
H5:  Strategies associated with higher levels of institutional feasibility and sustainability of 
Bright IDEAS-AC affect provider burden and teamwork and institutional resources and 
workflow.   
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2.0
Background
A. Patient Role in the Implementation of Survivorship Care Guidelines. According to the National 
Cancer Institute‘s definition, “An individual is considered a cancer survivor from the time of 
diagnosis through the balance of his/her life.”3 Using this definition, the population of survivors 
approaches 15.5 million people nationally (2016) and is expected to reach 18 million by the end 
of the decade.4 According to the current clinical guidelines from the Institute of Medicine and the 
American Society of Clinical Oncology,5 all cancer patients should receive individual cancer 
survivorship care plans (SCPs) from their medical oncologists (Appendix 1). The SCP is a 
document detailing patient-specific risk factors for cancer recurrence and side effects (physical, 
psychosocial, socioeconomic), a follow-up care schedule, available resources, and health 
management considerations and should be administered by the patient’s primary care provider, 
treating medical oncologist, or both, with support from a multidisciplinary survivorship care team. 
Lack of reliable evidence of SCP effectiveness is often cited as a reason why clinicians rarely 
discuss the potential usefulness of adhering to their SCP with patients.5-7 At the same time, recent 
publications8-11 have clearly demonstrated that studies evaluating SCP effectiveness have suffered 
from significant implementation errors12 and omitted analysis of critically important components 
of SCPs such as patient role in SCP implementation, follow-up care, and care coordination, as well 
as mode and frequency of SCP presentation. Each of these elements could independently affect 
SCP use and patient outcomes, and several of these elements need to be implemented in concert 
to achieve optimal outcomes. Our study is the first step in developing a patient-level intervention 
(PSST: problem-solving skills therapy) to improve patient ability to utilize SCP. Our target will be 
patients who have greater than average distress and so are more likely to benefit from the PSST 
intervention and ultimately, from their SCP.
B. Patient Barriers to Survivorship Care Use. The reasons for limited implementation of SCP are 
multifactorial and include lack of patient self-management skills and accurate information about 
available options and their trade-offs, patient emotional and financial distress, and lack of care 
coordination among others.8,10,13 Recent evidence demonstrates4,14,15 that cancer survivors are 
often distressed and overwhelmed by the burden of decision making and prioritizing among family 
obligations and self-care, employment and 
disability-related 
issues, 
coordination 
of 
primary 
care 
and 
specialist 
services, 
transportation to appointments, insurance 
coverage and other costs. Other co-occurring 
factors that also compromise patient decision-
making abilities are treatment-related fatigue 
and 
cognitive 
problems, 
anxiety 
about 
potential cancer recurrence and body image, 
and other life-altering consequences of cancer 
diagnosis.4,14-19 Strong evidence indicates that 
living in a rural area or a long distance from a cancer center and limited availability of cancer 
specialists (which is typical for many rural areas in the US) exacerbate the burden of patient 
decision making and represent a barrier to survivorship care.20,21 According to the American 
Society of Clinical Oncology’s (ASCO) recent workforce analysis, only 3% of medical oncologists 
practice in rural areas, whereas 20% of the US population resides in rural areas, and over 70% of 
counties in the United States do not have medical oncologists.22 An Iowa study found that of all 
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cancer patients diagnosed in Iowa between 2004 and 2010, 63% resided in a hospital service area 
(HSA) with a local oncologist, 29% resided in an HSA with a visiting oncologist, and 8% resided 
in an HSA with no oncologist; those in areas with no local oncologist traveled an average of 58 
minutes to receive chemotherapy.23 Impending physician retirements and financial pressures on 
small community oncology practices may exacerbate access issues in rural areas in the coming 
years.24
Effect of Distress on Cancer Patients Self-Management Ability and Treatment Adherence. The 
National Comprehensive Cancer Network (NCCN) defines distress in cancer as a “multifactorial 
unpleasant emotional experience of a psychological (cognitive, behavioral, emotional), social 
and/or spiritual nature that may interfere with the ability to cope effectively with cancer, its 
physical symptoms and its treatment.”25,26 Cancer patients report a wide range of distress 
symptoms from feelings of vulnerability to problems that disrupt their daily living.27 Twenty-nine 
to forty-three percent of cancer patients experience significant psychosocial distress.28 Cancer 
survivors have the highest levels of distress in times of care transition including, but not limited 
to, time of diagnosis, waiting for the start of treatment and after the completion of definitive 
treatment (“feeling abandoned by their oncologist”).28-30 Evidence demonstrates that negative 
affectivity and poor problem-solving skills are associated with poor treatment adherence in 
patients with cancer as well as poor quality of life, low physical and social functioning and poor 
prognosis.16-19 There have been no studies to date, however, examining whether improvement in 
problem-solving skills and alleviation of behavioral issues translates into better survivorship care, 
e.g., better patient self-management of late effects of cancer therapy, better adherence to the SCP, 
and lower overall and out-of-pocket associated costs.
Table 1: Top clinical problem list for cancer survivors 31
Clinical Problems
Social Problems & Concerns
Chemo induced Peripheral Neuropathy
Transportation
Cognitive impairment (chemo brain)
Care coordination between multiple provider 
offices
Fatigue
Disability and sick time from work
Body 
image 
(Breast 
reconstruction, 
ostomy care, and bowel and bladder 
problems)
Billing and reimbursement issues
Depression, worry, fear, distress
Provider communication/shared decision 
making
Focus on Colorectal, Breast, Bladder and Prostate Cancers. As of January 1, 2019, it is estimated 
that colorectal, breast, prostate and bladder survivors comprise more than a third (36% for men 
and 44% for women) of 16 million cancer survivors alive in the US.7 Potential long-term and late 
physical effects affecting cancer survivors are substantial and include chronic peripheral 
neuropathy, infertility, secondary cancers, bowel, and bladder dysfunction (Table 1). Survivors 
also experience psychosocial issues such as distress, depression, anxiety, body image, sexual 
dysfunction and intimacy concerns that may vary depending on patient sex, as well as financial 
issues resulting from workforce displacement and/or costs of treatment31. Focusing on these 4 
cancer types allows us to work with high risk clinically diverse and gender balanced population 
and to assess the feasibility of recruiting and providing therapy to both male and female patients 
as well as caregivers of both genders (addressing SEX AS BIOLOGICAL VARIABLE).
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3.0
Inclusion and Exclusion Criteria
The survivorship program coordinator (WCI - patients at all locations) and clinic nurse 
manager (Roswell Park patients) together with the study RAs will identify adult cancer 
patients who have completed  treatment for stage I-III CRC, B, BI or P cancers and who 
are eligible for survivorship consultation using the clinic scheduling system and EHR and 
consulting with oncology team as needed. Each survivor will be asked to identify and 
bring along a personal caregiver/supportive other (SO). We will determine the 
number/proportion of patients who identify and bring a caregiver and describe 
characteristics of the caregiver group. No inclusion/exclusion criteria are proposed for the 
caregivers/SOs 
Inclusion Criteria
To be included in this study, subjects must meet the following criteria:
1. Stage I-III CRC, B, BI and P. 
2. Meet the screening criteria for psychological distress (NCCN Distress >2, PROMIS 
Anxiety >50 or any other clinical measure of mild distress).
3. Be able to speak English.
4. Have a 5-year survival rate of 50% or greater as deemed by their oncologist, surgeon, 
or other relevant attending physician (suggesting a reasonable rate of cure or 
prolonged medical survival with state-of-the-art medical care). 
5. Be willing to provide written informed consent to participate in the study which 
includes several clinical evaluations, provide access to medical records/PCP, and 
allow all interviews and PSST therapy sessions to be audiotaped. 
6. Among patients treated in the urban centers, we will specifically target patients who 
live more than 40 miles away from the clinic as they are more likely to experience 
problems with access to care.
7. Age 21 or older.
Exclusion Criteria
Participants will be excluded from the study for the following:
1. A diagnosis of mental retardation, and/or
2. Acute suicidal behavior. 
Inclusion of Women and Minorities
Both men and women and members of all races and ethnic groups are eligible for this study.
Special Populations
The following special populations are excluded from this study:

   Cognitively impaired adults/adults with impaired decision-making capacity

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
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INVESTIGATOR STUDY ELIGIBILITY VERIFICATION FORM:
INCLUSION CRITERIA
Participant Name: (Multi-site use participant initials): ___________________________
Medical Record No.: (Multi-site use participant ID): _____________________________
Title: Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
INCLUSION CRITERIA
Yes
No
N/A
All answers must be “Yes” or “N/A” for participant 
enrollment.
Date
1. Stage I-III CRC, B, BI and P. 
2. Meet the screening criteria for psychological distress 
(NCCN Distress >2, PROMIS Anxiety >50 or any other 
clinical measure of mild distress).
3. Be able to speak English.
4. Have a 5-year survival rate of 50% or greater as deemed 
by their oncologist, surgeon, or other relevant attending 
physician (suggesting a reasonable rate of cure or 
prolonged medical survival with state-of-the-art medical 
care). 
5. Be willing to provide written informed consent to 
participate in the study which includes several clinical 
evaluations, provide access to medical records/PCP, and 
allow all interviews and PSST therapy sessions to be 
audiotaped. 
6. Among patients treated in the urban centers, we will 
specifically target patients who live more than 40 miles 
away from the clinic as they are more likely to 
experience problems with access to care.
7. Age 21 or older.
Investigator Signature: ___________________________________
Date: ___________
Printed Name of Investigator: __________________________________________________
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INVESTIGATOR STUDY ELIGIBILITY VERIFICATION FORM:
EXCLUSION CRITERIA
Participant Name: (Multi-site use participant initials): ___________________________
Medical Record No.: (Multi-site use participant ID): _____________________________
Title: Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC
EXCLUSION CRITERIA
Yes
No
N/A
All answers must be “No” or “N/A” for participant 
enrollment.
Date
1. A diagnosis of mental retardation or severe cognitive 
problems.
2. Acute suicidal behavior.
Participant meets all entry criteria:
  Yes
  No
If “NO”, do not enroll participant in study.
Investigator Signature: ___________________________________
Date: __________
Printed Name of Investigator: _________________________________________________
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4.0
Local and Study-Wide Number of Subjects
4.1
Based on the participating sites enrollment history, we expect an average enrollment rate of 3 new 
survivors a month at Wilmot Cancer Institute (WCI), 2 from RPCI (up to 20), and 1 new  survivor 
every other month at Noyes Memorial Hospital (NMH), an offsite Wilmot Cancer Institute 
location, for 10 months. We will stop enrollments once we achieve 50 participants. We plan to 
recruit 50 patients and as many caregivers as possible.
4.2
One of the study goals is to estimate attrition rate for this protocol.
5.0
Local and Study-Wide Recruitment Methods
Response: The study recruitment will start in Month 7 and continue for 10 months with last patient 
completing the follow-up by Month 23 (Figure 2). To ensure that men and women are adequately 
represented in the study sample, study randomization will be stratified by sex. In this study, we 
will pay close attention to the impact of patient sex and gender on their unmet needs and self-
reported issues (for instance, female CRC survivors may be less comfortable discussing their 
bowel issues and body image with their male partners and prefer to use a sister or a female friend 
as a caregiver). Based on the results of the study, we may develop a differential recruitment and/or 
training strategy for the future multisite study. For instance, if we find out that male cancer 
survivors are more likely to drop out of therapy or prefer face-to-face therapy (vs. over the phone), 
we will take that into account when designing the intervention for the larger pragmatic study. The 
survivorship program coordinator (WCI - patients at all locations) colorectal clinic nurse manager 
(RPCI patients) together with RAs will identify adult cancer patients who have completed adjuvant 
treatment for stage I-III cancer and who are eligible for survivorship consultation. Two weeks 
before the scheduled survivorship appointment, the survivorship nurse/clinic nurse manager will 
send the patient a study letter followed by a phone call, telling them about the study goals and 
procedures (e.g., duration of assessment and frequency of follow-up) and inviting them to 
participate. Patients who express interest will meet with the study RA in the location of their choice 
(hospital, clinic or patient home). To determine patient eligibility, patients will be screened for 
cancer-related distress using the NCCN Distress Thermometer (Appendix 2). Patients who are 
experiencing psychological distress (NCCN Distress >2 cut-off has 100% sensitivity, PROMIS 
Anxiety >50 or any other clinical measure of mild distress), and who meet the study’s other 
inclusion and exclusion criteria (see below) will be invited to participate (patient with the distress 
level 4 or greater will be referred to additional behavioral therapy). If a person is willing to continue 
the screening process by providing written informed consent, he or she will then be asked to 
complete their baseline evaluation consisting of a battery of self-report measures (Table 2). The 
cancer patient will also be asked to identify a Supportive Other (SO) who might serve as a problem-
solving partner.
We budget $100 incentive for each patient in the form of VISA gift cards to facilitate patient 
recruitment, completion and return of the study evaluation forms and data collection.  Patients will 
receive $25 for completing the baseline assessment, another $25 for completing 3-month 
assessment and $50 for completing the close-out assessment at about 6 months (including semi-
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structured interviews). Each supportive other will receive $25 gift card for each returned 
evaluation form.
6.0
Multi-Site Research
6.1
Drs. Sahler (Wilmot Cancer Institute) and Noyes (UB/RPCI) will serve as Principal Investigators 
on the proposed study, with Dr. Noyes serving as the Contact PI. Their complementary skills and 
research interests will ensure successful completion of the stated aims. Importantly, both 
investigators contributed significantly to the intellectual conceptualization of the proposed study 
that arose from several years of their collaborative work on the Wilmot Cancer Institute (WCI) 
Multidisciplinary Survivorship team.
The roles and responsibilities of the two PIs are relatively discrete with Dr. Sahler leading  the 
development/revision of all intervention materials and the training and supervision of the RAs in 
the delivery of the intervention. Dr. Noyes will oversee patient recruitment, data collection and 
analysis. Any areas of potential dispute will be resolved by consensus with input from the entire 
team.
All three sites will use the same recruitment materials and protocol. The Roswell Park IRB will 
serve as the IRB of record for all study sites. The proper IRB Authorization Agreements has been 
obtained for each site.

All sites have the most current version of the protocol, consent document, and 
HIPAA authorization.

All modifications have been communicated to sites, and approved before the 
modification is implemented.

All engaged participating sites will safeguard data, including secure 
transmission of data, as required by local information security policies.

All local site investigators will conduct the study in accordance with 
applicable federal regulations and local laws.

All non-compliance with the study protocol or applicable requirements will be 
reported in accordance with local policy.
6.2
The MPIs will discuss study progress on an as-needed basis but no less frequently than weekly. 
Dr. Sahler will also serve as de-facto a site lead for the Rochester team and Dr. Noyes will be 
responsible for the Buffalo and Dansville teams including weekly meetings and communication.  
A joint (all-project) conference call will be held monthly.
7.0
Study Timelines
7.1
The study recruitment will start in Month 7 and continue for 10 months with last patient completing 
the follow-up by Month 23.
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8.0
Study Endpoints
8.1
We will collect data to help quantify the burden of enrollment process including duration of the 
initial meeting between the patient and study coordinator and informal consent, number, duration 
and content of subsequent meetings and phone calls before and after patient/SO enrollment. At 
every stage, we will capture patient feedback and reasons for refusal to participate.
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Table 2: Study self-reported instruments and questionnaires administered at T0, T1, and T2* 
Instrument
Short 
title
Number of 
items
Total 
score
Description
Social Problem-Solving 
Inventory-Revised32,33 
(Appendix 5)
SPSI-R
52
0-20
±Problem Orientation, 
Rational Problem Solving, 
Impulsivity/
Carelessness Style, 
Avoidance Style
Patient Health 
Questionnaire-234
 (Appendix 6)
PHQ-2
2
0-6
scoring each answer as 0 
(“not at all”) to 3 (“nearly 
every day”)
Hospital Anxiety and 
Depression 
Scale35,36(Appendix 7)
HADS
7+7
0-21
Depression/anxiety 
symptoms over the last 
week; scores >11 
considered abnormal
The Functional Assessment 
of Cancer Therapy–disease 
specific37(Appendix 8)
FACT-
C
FACT-
B
FACT-
BI
FACT-
P
36
0-136
5-8 ~clinically 
significant
Reported based on the past 
7 days
*For each metric, we will test for internal consistency ratings across the three assessment time 
points (T0, T1, and T2).
Healthcare utilization. All patients in the intervention and control arms at the time of T0, T1, and 
T2 assessments will be asked about their healthcare utilization since the last assessment including 
primary care, specialist and ED visits and any hospital stays. This information will be validated 
with the patient SO and medical record/PCP. We will also ask about reasons for the visits to further 
distinguish utilization into avoidable (consequence of poor quality of care or insufficient self-
management skills) and unavoidable (true healthcare emergency).
9.0
Design
Bright IDEAS-AC is a PSST intervention for adult colorectal cancer survivors and their caregivers 
designed to improve patient ability to participate in and benefit from SCP (Figure 2) This study 
will take place at three different settings, a hospital affiliated cancer center (Wilmot Cancer 
Institute (WCI), Rochester, NY), a free- standing NCI-designated cancer center (Roswell Park 
Cancer Institute (RPCI), Buffalo, NY) and a rural community oncology clinic (Myers Cancer 
Center, Dansville, NY) affiliated with WCI. 
Bright IDEAS Adult Cancer (Bright IDEAS-AC) will be delivered in the most patient-friendly 
way. Sessions 1 and 8 (S1, S8) will be face-to-face at the location of patient choice (hospital, clinic, 
or participant’s home). The rest of the sessions (S2-7) will be delivered over the phone by research 
assistants (RAs) who have received training in PSST skills building and supervision. Before 
enrollment, each participating cancer survivor will receive a description of the Bright IDEAS-AC 
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intervention, associated goals, and the randomization procedure in an informed consent document. 
Upon completion of the baseline assessment (Time 0) (Table 2), subjects will be randomized to 
the intervention or control arm in a 1:1 fashion using a stratified permuted block randomization 
scheme with stratification variables by patient sex and study site, using small blocks of size 2. The 
randomization lists will be generated by the study biostatistician (GW). All participants will 
undergo another self-assessment 3 months after enrollment (Time 1, by which time patients in the 
active treatment arm should have completed their PSST training) and at 6 months (Time 2). 
Participants will receive a modest stipend after each returned evaluation to compensate them for 
their time. The materials for the baseline (T0) assessment will be given to the patients during the 
baseline face-to-face meeting (S1). The RA will phone the patient reminding him/her about the 
upcoming follow-up assessment and will confirm the best way of delivering the self-assessment 
instruments (in clinic, online, email, or postal mail). 
The PSST intervention will consist of eight one-hour individual weekly sessions conducted 
according to the previously published comprehensive protocol as summarized below. Problem 
solving is presented as a general coping skill applicable to a range of challenging circumstances 
commonly encountered by cancer survivors (Table 1). To promote patient engagement, the 
patients will be encouraged to identify specific problems particularly relevant to them and to their 
family’s situation (instead of providing them with standardized examples) to be discussed and 
“solved” during the PSST sessions. The eight sessions of PSST will be organized in a systematized, 
therapeutic manner. Session 1 will be face-to-face and devoted to rapport building and 
understanding relevant social and medical information. The therapist (RA) will introduce PSST 
and the Bright IDEAS paradigm, present worksheets to guide PSST homework assignments, and 
give an overview of subsequent sessions. Starting at Session 2, participants will continue training 
over the phone, with the same general structure and format. In Sessions 2–7, the therapist and 
patient, with a supportive other (SO) if available, will review the patient’s identified problems and 
work on application of problem-solving strategies and skills learned earlier.
For patients who struggle to define a problem, we will offer a choice from a list of typical CRC 
survivor problems developed by the research team with input from the clinical teams (Table 1). 
Session 8 will be conducted face-to-face and dedicated to a review of PSST training and relapse 
prevention, emphasizing persistence and learned optimism, and the process of termination. Note: 
Two RAs will be employed for this project. The RA not providing the intervention to a given 
patient will schedule the T1 assessment after Session 8 for the intervention arm and at 3 months 
post-randomization for the CAU patients and the T2 assessment 3 months later. Process notes will 
be recorded in a systematized format across both intervention arms at all data collection sites and 
kept in each participant’s study file and entered electronically into REDCap.  
Treatment Integrity (TI): We believe integrity of treatment implementation (i.e., assurance that 
interventions are conducted as intended by a competent therapist) is a critical feature of well-
controlled outcomes research.  Although the use of manuals does much to address this issue, 
systematic assessment of integrity must be conducted to draw firm conclusions about differential 
treatment effects, if any. Tests of TI are also important when interventions are conducted at 
multiple sites by different providers to identify any confounding site/personality effects. To assure 
TI, every session will be audiotaped, identified only by subject code, and uploaded to a secure site 
maintained by the project coordinator and MPIs. Twenty percent of the PSST tapes (0.2 * (25 
subjects *8 sessions) = 40 tapes) will be chosen at random for review by Dr. Sahler according to 
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a checklist of content items and personal responses that have been used for prior projects. Feedback 
about any TI concerns will be delivered during supervision sessions with the study RAs.   
10.0
Treatment
Bright IDEAS Adult Cancer (Bright IDEAS-AC): The PSST intervention will be delivered in the 
most patient-friendly way. Sessions 1 and 8 (S1, S8) will be face-to-face at the location of patient 
choice (hospital, clinic, or participant’s home). The rest of the sessions (S2-7) will be delivered 
over the phone by research assistants (RAs) who have received training in PSST skills building 
and supervision. Before enrollment, each participating cancer survivor will receive a description 
of the Bright IDEAS-AC intervention, associated goals, and the randomization procedure in an 
informed consent document. All sessions will be audiotaped for quality assurance 
Care As Usual Group (CAU): Participants randomized to the CAU group will be observed under 
naturalistic conditions. Both PSST and CAU participants and their clinicians (PCP and oncology 
providers) will be allowed to use any clinically appropriate medical and behavioral care without 
restriction (e.g., care management, rehabilitation, behavioral therapy, palliative care) or refer 
patients to social and community services (e.g., peer support, county cancer services program or 
aging services). The CAU participants will undergo the same evaluation protocol as the PSST 
group. After study completion, the CAU participants will be offered the PSST training manuals.  
11.0
Procedures Involved
The Months 1-6 of the project is the adaptation phase. Using the NCI Guidelines for Choosing and 
Adapting RTIPs1,2 and RE-AIM framework for implementation and dissemination, we will start 
by revising the program materials and training protocol to adapt them for the needs of cancer 
survivors and their caregivers. While the basic principles and approaches of PSST are generalized 
to a wide range of health and non-health related situations (e.g., providing at home care-giving to 
a disabled spouse, waiting for a refugee status after being displaced from your home county during 
a civil war crisis), using relevant examples will accelerate learning and improve information 
retention and new skills development. Based on the analysis of CRC survivorship literature and 
qualitative interviews with community oncology providers (VROC preliminary data), we have 
identified five most common clinical problems that affect cancer survivors and five social issues 
that all cancer survivors have a hard time dealing with (Table 1). Working together, the project 
team will review the Bright IDEAS materials to identify areas (processes, timing or examples) that 
are unique for mothers of pediatric cancer patients but not relevant for adult cancer survivors and 
their caregivers (ex., prioritizing between the care for the sick child and the needs of his healthy 
siblings). Using the experience and expertise of the project team, we will adapt these materials to 
reflect specific challenges that cancer survivors are likely to experience and/or have difficulty 
addressing. Once all revisions are completed, the updated manuals and materials will be piloted 
with 5 adult cancer survivors and their caregivers. Their feedback will be reviewed by the study 
team and incorporated in the study documents. The revised materials will be then pilot-tested with 
5 adult cancer survivors and caregivers from WCI. The study team will review the results of the 
pilot test and make any necessary changes to the study approach.
The study recruitment will start in Month 7 and continue for 10 months with last patient completing 
the follow-up by Month 23 (Figure 2). To ensure that men and women are adequately represented 
in the study sample, study randomization will be stratified by sex. In this study, we will pay close 
attention to the impact of patient sex and gender on their unmet needs and self-reported issues (for 
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instance, female cancer survivors may be less comfortable discussing their bowel issues and body 
image with their male partners and prefer to use a sister or a female friend as a caregiver). Based 
on the results of the study, we may develop a differential recruitment and/or training strategy for 
the future multisite study. For instance, if we find out that male cancer survivors are more likely 
to drop out of therapy or prefer face-to-face therapy (vs. over the phone), we will take that into 
account when designing the intervention for the larger pragmatic study. 
The survivorship program coordinator (WCI - patients at all locations) and colorectal clinic nurse 
manager (RPCI patients) together with RAs will identify adult cancer patients who have completed 
adjuvant treatment for stage I-III cancer and who are eligible for survivorship consultation. Two 
weeks before the scheduled survivorship appointment, the survivorship nurse/CRC nurse manager 
will send the patient a study letter followed by a phone call, telling them about the study goals and 
procedures (e.g., duration of assessment and frequency of follow-up) and inviting them to 
participate. Patients who express interest will meet with the study RA in the location of their choice 
(hospital, clinic or patient home). 
To determine patient eligibility, patients will be screened for cancer-related distress using the 
NCCN Distress Thermometer (Appendix 2). Patients who are experiencing psychological distress 
(NCCN Distress >2 cut-off has 100% sensitivity),62 and who meet the study’s other inclusion and 
exclusion criteria (see below) will be invited to participate (patient with the distress level 4 or 
greater will be referred to therapy). If a person is willing to continue the screening process by 
providing written informed consent, he or she will then be asked to complete their baseline 
evaluation consisting of a battery of self-report measures (Table 2). The cancer patient will also 
be asked to identify a Supportive Other (SO) who might serve as a problem-solving partner. 
Inclusion and exclusion criteria: To be eligible to participate in this study, individuals will need to 
(a) meet the screening criteria for psychological distress (NCCN Distress >2, PROMIS Anxiety 
>50 or any other clinical measure of mild distress); (b) be able to speak English; (c) have a 5-year 
survival rate of 50% or greater as deemed by their oncologist, surgeon, or other relevant attending 
physician (suggesting a reasonable rate of cure or prolonged medical survival with state-of-the-art 
medical care); and (d) be willing to provide written informed consent to participate in the study 
which includes several clinical evaluations, provide access to medical records/PCP, and allow all 
interviews and PSST therapy sessions to be audiotaped. Exclusion criteria include the presence of 
(a) a diagnosis of mental retardation, and/or (b) acute suicidal behavior. Among patients treated in 
the urban centers, we will specifically target patients who live more than 40 miles away from the 
clinic as they are more likely to experience problems with access to care. All study procedures and 
materials will be reviewed and approved by the Institutional Review Board to ensure maximum 
protection of patient privacy and confidentiality, HIPAA compliance, and appropriate data 
handling (see Data and Safety Monitoring Plan). Sample size justification: Based on the 
participating sites enrollment history, we expect an average enrollment rate of 3 new cancer 
survivors a month at WCI, 2 from RPCI, and 1 new cancer survivor every other month at NMH 
for 10 months (Figure 2). We will stop enrollments once we achieve 50 participants. 
The RAs will collect patient self-reported demographic, clinical, and socio-economic information 
at the baseline (age, gender, race/ethnicity, employment status, education, health insurance, place 
of residence, living arrangements, diagnosis, SCP or treatment history and time since diagnosis 
and end of treatment) as well as the information about the SO (age, sex, education level, 
religion/ethnicity, racial background, cancer history and relationship to the patient). We will 
collect data to help quantify the burden of enrollment process including duration of the initial 
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meeting between the patient and study coordinator and informal consent, number, duration and 
content of subsequent meetings and phone calls before and after patient/SO enrollment. At every 
stage, we will capture patient feedback and reasons for refusal to participate.  
Caregivers are asked to play their usual supportive role and invited to participate in the therapy 
sessions and exercises, talk with patients about their problems, offer solutions and emotional 
support. They are also invited to participate in evaluations and qualitative interviews.
All patients in the intervention and control arms, as well as any participating caregivers, at the time 
of T0, T1, and T2 assessments will be asked about their healthcare utilization since the last 
assessment including primary care, specialist and ED visits and any hospital stays. This 
information will be validated with the patient SO and medical record/Primary Care Provider (PCP) 
office staff. For RPCI patients, information about number and  timing of care visits will be 
requested electronically. For external patients, the RA will call the PCP office staff and confirm 
all patient-reported clinic visits after the medical record release form is signed. We will also ask 
about reasons for the visits to further distinguish utilization into avoidable (consequence of poor 
quality of care or insufficient self-management skills) and unavoidable (true healthcare 
emergency). 
Using in-depth semi structured interview approach, we will explore the viewpoints of participating 
stakeholders in diverse clinical and social settings (including patients from various family and 
religious backgrounds, caregivers, clinic staff and administration for each clinical setting) 
regarding how the intervention design, the external environment and infrastructure may influence 
Bright IDEAS-AC adoption and sustainability. We will ask stakeholders about the time they spent 
on the intervention-related activities, how optimistic they were about the impact of the 
intervention, and their confidence in the intervention (Appendix 7). We plan to conduct five 1-
hour interviews each year, which will be professionally transcribed and analyzed by the study 
implementation scientist. We strategically selected an outside consultant (DM) who has no 
personal ties to the study organizations to minimize subjective validation bias and promote open 
communication with the stakeholders. The results of the SA3 analysis will be shared with the study 
team to inform any changes to the study approach and planning of subsequent multisite trial.  
At any point during the study, a participant, caregiver, or clinical staff may receive a phone call 
from the study consultant Dr. Demetria McNeal from the University of Colorado at Denver. Dr. 
McNeal will randomly select up to 10 patients and up to 5 supportive others to ask them about 
how participation in this study may affect their lives and clinical care. The participation is 
voluntarily; the phone call should take about an hour. A written letter will be sent to selected 
participants to make them aware that Dr. McNeal will be contacting them.
12.0
Withdrawal of Subjects
As long as the subjects are willing and able to participate in the study, they will be kept in the 
study and followed as planned. 
13.0
Risks to Subjects
We are unaware of any potential risks from participation and have seen no reports of adverse 
effects during the prior PSST projects (total n=900 subjects). All records will be kept strictly 
confidential as required by the policies and procedures of the participating institutions. Should a 
subject become distressed while completing a questionnaire or participating in an intervention 
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session to an extent that exceeds the research assistant’s clinical experience, the issue will be 
discussed with the site PI or the subject will be referred to a mental health professional as 
appropriate. Provision of 1 hour of supervision for each four hours of subject contact and review 
of a sample of audiotapes from therapy sessions by Dr. Sahler, experienced licensed health 
professional, adds another layer of monitoring to ensure subject safety.
14.0
Potential Benefits to Subjects
Subjects will receive immediate benefit from participating in the study in the form of improved 
problem-solving skills, reduction in emotional distress, improvement in confidence and affect. 
Compared with mothers of children diagnosed with cancer who received usual care, PSST mothers 
reported significantly enhanced problem-solving skills (SPSI-R score12.55 vs. 11.46, p=0.003) 
and significantly decreased negative affectivity,38 even after the active PSST had stopped.38-41
15.0
Data and Specimen Banking
Returned subject questionnaires will be kept in the PI’s office in locked storage cabinets.
Electronic data will be stored on password protected HIPAA-compliant shared drive accessible 
to the qualified study personnel only. 
Address:
School of Public Health and Health Professions
University of Buffalo
270C Farber Hall
Buffalo, NY
Department: Division of Health Services Policy and Practice
Department of Epidemiology and Environmental Health
16.0
Measurement of Effect
Using study self-reported instruments and questionnaires administered at T0, T1, and T2, we will 
track changes in-patient problem-solving skills, depression, anxiety, and GI functioning (see 
Section 8.1 Table 2). While this feasibility study is not powered to detected statistically significant 
changes in the tracked metrics, we will use GEE approach to perform trend analysis and controlling 
for multiple observation per person over time.
17.0
Safety Evaluation
N/A
18.0
Data Management and Confidentiality
18.1 Waiver of HIPPA Authorization
Using random number generator, each subject will be randomized to either intervention or care 
as usual arm. Two RAs will be employed for this project. The RA not providing the intervention 
to a given patient will schedule the T1 assessment after session 8 for the intervention arm and at 
3 months post-randomization for the CAU patients and the T2 assessment 3 months later. The 
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RAs will collect all evaluation forms and electronically input data into REDCap database using 
subject Study ID for identification. The crosslink between the Study ID and subject person-
identifiable information will be stored separately and not available to the study analyst, to 
minimize any bias. The research database available for analysis will contain no person 
identifiable information (e.g., name or address). All individuals who will have access to data 
have completed all the necessary training for working with PHI data, institutional and federal 
regulations compliance, conflict of interest and good clinical practice training. The department 
administrator maintains the records of certification and issues reminders when re-certification is 
due.
All collected data will stored in accordance with the Roswell Park and UB data security 
policies. The respondent database will be maintained on a secure, network encrypted 
shared drive that is password protected, in a locked research office.  The database will be 
maintained for a period of 5 years, after which time it will be destroyed. 
The data will be accessed only from a UB or Roswell Park secure password protected computer 
by pre-identified and appropriately trained faculty and staff. All faculty and staff have private 
locked offices. 
19.0
Statistical Plan
We will compare characteristics of patients who enrolled and did not enroll in the study including 
characteristics of the settings where the initial contact took place (e.g., doctor’s office, waiting 
room, or other). We will calculate proportion of recruited and retained cancer patients and their 
SOs for the PSST training, proportion of completed and returned 3- and 6 month evaluations, 
recruitment rates for various sites, and patient personal time spent on the intervention-related 
activities (H1, 2, and 4). To evaluate acceptability, we will assess patients’ perceptions of the 
intervention burden immediately after Sessions 1, 4, and 8 (or the last session in the case of early 
mastery or termination) (H3). Healthcare utilization will be compared between the study arm using 
count data models (Poisson and negative binomial for trend analysis only).  All statistical analyses 
will be carried out using SAS version 9.4 (or higher) statistical software (Cary, NC).   
20.0
Provisions to Monitor the Data to Ensure the Safety of Subjects
N/A 
21.0
Vulnerable Populations
N/A 
22.0
Community-Based Participatory Research
The design of this feasibility study was informed by our findings from a prior project, Virtual Rural 
Oncology Community (V-ROC). V-ROC is a PCORI-funded study (Eugene Washington PCORI 
Engagement Award Contract # 2481- Rochester) that aims to engage all stakeholders involved 
with rural cancer care in an effective and transparent process of decision making to achieve better 
outcomes for this hard-to-reach population. The stakeholders include rural cancer patients, their 
caregivers, county public health departments, community organizations and services, and a wide 
spectrum of healthcare providers. Prior work on this project provided preliminary data on 
feasibility of recruitment of rural cancer survivors and informed our understanding of unmet needs 
and barriers to survivorship care in rural cancer survivors. For instance, a large proportion of 
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elderly rural patients have limited experience using the internet and electronic devices and are also 
uncomfortable using technology in healthcare. Based on this evidence, we decided against using a 
PDA or an online PSST modality and made the first PSST session face-to-face, to be delivered by 
the research assistant at the hospital or clinic or patient’s home. 
23.0
Sharing of Results with Subjects
Only aggregate results (enrollment and drop-out rate, average time to recruit a subject and to 
complete study evaluation) from this study will be shared with participating providers to appreciate 
their time and effort, assist with data interpretation, to ensure data validity and build partnership 
to facilitate enrollment in the subsequent multicenter pragmatic RCT study.
24.0
Setting
This study will take place at three different settings, a hospital affiliated cancer center (Wilmot 
Cancer Institute (WCI), Rochester, NY), a free standing NCI-designated cancer center (Roswell 
Park Cancer Institute (RPCI), Buffalo, NY) and a rural community oncology clinic (Myers Cancer 
Center, Dansville, NY) affiliated with WCI. The survivorship program coordinator (WCI - patients 
at all locations) and clinic nurse manager (RPCI patients) together with RAs will identify adult 
cancer patients who have completed adjuvant treatment for stage I-III cancer and who are eligible 
for survivorship consultation. Two weeks before the scheduled survivorship appointment, the 
survivorship nurse/clinic nurse manager will send the patient a study letter followed by a phone 
call, telling them about the study goals and procedures (e.g., duration of assessment and frequency 
of follow-up) and inviting them to participate. Patients who express interest will meet with the 
study RA in the location of their choice (hospital, clinic or patient home).
25.0
Provisions to Protect the Privacy Interests of Subjects
Only study coordinators and RAs will know the identity of the patients. Once the data are collected 
(from patient EHR and study instruments) and inputted into REDCap database, each patients will 
be refereed to only by their study ID.  The study participation can be discontinued at any time and 
patients may decline to answer any questions they find upsetting.  
The subjects will be initially approached by their clinic staff to inform them about the study. Only 
subjects who expressed interest in the study will be then contacted by the study team. All members 
of the subject’s clinical team will receive information about the study and will be qualified to 
discuss with the study subjects their questions/concerns. The study participation can be 
discontinued at any time and patients may decline to answer any questions they find upsetting. The 
study RAs are certified therapists and are qualified to handle patient distress or refer them to mental 
health providers as appropriate.
Only study coordinators and RAs will be allowed to access information about the subjects in the 
EHR system for the purpose of confirming subject eligibility, abstracting their medical history and 
scheduling the first meeting with the therapist. The de-identified study data will be accessed only 
from a UB or Roswell Park secure password protected computer by pre-identified and 
appropriately trained faculty and staff.
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26.0
Resources Available
Ekaterina (Katia) Noyes, PhD, MPH, Contact MPI
Katia Noyes, PhD, MPH is Professor and Director, Division of Health Services Policy and 
Practice, Department of Epidemiology and Environmental Health, at the School of Public Health 
and Health Professions of The State University of New York at Buffalo (UB). She is also Adjunct 
Professor of Oncology at Roswell Park Cancer Institute (RPCI) in Buffalo, NY.
DUTIES FOR THIS PROJECT: Dr. Noyes will serve as the contact MPI on this project. In this 
capacity she will be responsible for general administration of the project and for overseeing all 
aspects of data collection, including development, completion and integrity of the REDCap 
database, personnel management, team meetings and communication, coding development, data 
analysis and findings dissemination. Dr. Noyes has collaborated extensively with all investigators 
and personnel on this project. 
BACKGROUND and EXPERIENCE: Dr. Noyes is a health services researcher with expertise in 
outcomes and comparative effectiveness research, economic assessment in healthcare and quality 
of care evaluation. The breadth of her scholarly productivity attests to her capacity to work in 
interdisciplinary teams and collaborate with researchers from diverse backgrounds. She has 
received funding from the National Institute of Health, Robert Wood Johnson Foundation, Agency 
for Healthcare Research and Quality, Patient Centered Outcomes Research Institute (PCORI), 
National Multiple Sclerosis Society and a variety of other public and private sources. Dr. Noyes 
has been involved in and led studies on evaluation of quality of life, cost and quality of long-term 
interventions, including outcomes and cost-effectiveness of treatment for colorectal, bladder and 
breast cancers, use of colonoscopy in Medicare patients living in rural areas, effect of frailty on 
Medicare costs, among others. She has conducted several studies using the SEER registry, 
National Surgical Quality Improvement Project (NSQIP) database, NYS hospital discharge 
abstract data (SPARCS), and Medicare administrative data. She is also familiar with 
methodological advances and limitations associated with using these data for research. She 
recently has spent 6 months in the UK, Canada and the leading US surgical outcomes and quality 
assessment centers learning state-of-the-art strategies and approaches for multidisciplinary 
oncology care. 
Since 2012, the core of this project team has performed an extensive analysis of cancer patient 
medical records, hospital discharge summaries, tumor registries and insurance claims data, and 
cancer stakeholders’ focus groups and interviews. The team has demonstrated that rural patients 
and minorities experience significant deficiencies in cancer care provided in rural communities 
(including poor adherence to national cancer care guidelines, lack of high-quality providers and 
higher medical costs). The team works closely with the URMC Regional Telemedicine Group and 
ECHO (Extension for Community Healthcare Outcomes) consortium and has extensive experience 
conducting tele- and video conferences and training for cancer patients, caregivers, and providers. 
PCORI funding (Eugene Washington PCORI Engagement Award Contract # 2481- Rochester)  
was used to develop a region-wide stakeholder network, “Virtual Rural Oncology Community” 
(V-ROC), led by Dr. Noyes, to facilitate stakeholder involvement in patient-centered outcomes, 
comparative effectiveness and health services research which could ultimately promote better 
decisions about regional cancer care delivery, improve the quality of regional cancer care, and 
reduce health inequalities between rural and urban communities. This experience guided the plan 
for patient recruitment strategy and choice of study design and outcomes.
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Gregory Wilding, PhD, Co-Investigator, Biostatistics
Dr. Wilding is the recently named Chair of the Department of Biostatistics at UB, after having 
served as the Interim Chair for over a year. He is also Director of the Epidemiology and Research 
Design Core of the Buffalo Clinical and Translational Research Center, and Professor of Oncology 
in the Department of Biostatistics and Bioinformatics, at Roswell Park Cancer Institute. He is 
skilled in a vast array of statistical analysis techniques and computer programming languages. His 
bio statistical interests are in the areas of clinical trials, computationally intensive methods, and 
tests for and measures of independence. 
DUTIES FOR THIS PROJECT: Dr. Wilding will oversee the direct randomization as well as the 
work of the data analyst and work closely with the study PI and the RAs to develop the REDCap 
data collection forms as well as the optimal risk-adjusted approach for data analysis given the 
limited power of the pilot study. Dr. Wilding will also be the project’s liaison with the Department 
of Biostatistics and RPCI. 
Other Personnel:
Jing Nie, PhD, Programmer/Data Analyst
Dr. Nie is Research Assistant Professor in the Department of Epidemiology and Environmental 
Health at UB and has worked in this capacity for eleven years. He has expertise in data 
management, programming and epidemiologic studies, and has been involved with data 
management and analysis from a diverse portfolio of research studies (e.g., New York State Angler 
Cohort Study, Alcohol studies, Western New York Exposures and Breast Cancer (WEB) Study, 
Atherosclerosis Risk in Communities (ARIC) Study, and Women’s Health Initiative (WHI)). He 
has advanced training in epidemiologic methods, statistics and statistical programming using SAS.
DUTIES FOR THIS PROJECT: Dr. Nie will work closely with Drs. Noyes and Wilding and the 
RAs to oversee data quality and management, create and manage data entry screens, and conduct 
analyses for the outlined specific aims, and any subsequent presentations and publications. 
Consultants:
Demetria McNeal, PhD, Dissemination Scientist Consultant 
Dr. McNeal is a dissemination science expert who has worked extensively with Dr. Sahler on R25 
CA183725 (Sahler & Noll, MPI) evaluating the reach of a project to train psychosocial oncology 
health care professionals in the use  of the Bright IDEAS paradigm of problem-solving skills 
training (PSST) in clinical practice. The R25 project represents an intermediate step in the 
dissemination of Bright IDEAS and will serve as the template for evaluating the dissemination 
potential of Bright IDEAS for adult cancer survivors, especially in rural settings.
DUTIES FOR THIS PROJECT:    During the time of the study recruitment, intervention and 
patient self-assessment, Dr. McNeal will conduct in-depth semi-structured interviews to explore 
the viewpoints of participating stakeholders in diverse clinical settings (including patients, 
caregivers, clinic staff and administration) regarding how the intervention design, the external 
environment and infrastructure influence program adoption. She will conduct five 1-hour 
interviews each year, which will be professionally transcribed (60 minutes/interview x 5 interviews 
x $0.02/min = $600/year, Years 01 and 02). Together with the rest of the study team, Dr. McNeal 
will analyze the interview data to inform any changes to the study design or planning of subsequent 
multisite trial.
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Steven Nurkin, MD, MS, FACS, Consultant
Dr. Nurkin is a fellowship-trained surgical oncologist who specializes in gastrointestinal 
precancerous conditions and cancers of the entire GI tract, with a focus in colon, appendix, rectum, 
and anus. His clinical research interests focus on improving the outcomes and quality of care in 
patients with cancer. He is a Quality Leader at Roswell Park Cancer Institute and spearheaded the 
implementation of Enhance Recovery After Surgery (ERAS) at RPCI. Dr. Nurkin is a panel 
member for the National Comprehensive Cancer Network and helps develop national guidelines 
for the management of these diseases.
DUTIES FOR THIS PROJECT: Dr. Nurkin will serve as the clinical expert on colorectal cancer, 
and as a liaison to the local, regional, and national CRC resources and expertise, including late 
treatment effect and surgical side effect management. Together with his clinical staff, they will 
recruit 2 patients per month over the 10-month recruitment period. They will introduce the study 
and link interested patients to the project RAs.
Tessa Flores, MD, Consultant
Dr. Flores is a fellowship-trained staff physician in Medical Oncology at Roswell Park Cancer 
Institute (RPCI) in Buffalo, NY, who specializes in breast cancers. Her clinical research interests 
focus on improving the outcomes and quality of care in patients with cancer. She is the Medical 
Director of the RPCI Screening and Survivorship Clinic.
DUTIES FOR THIS PROJECT: Dr. Flores will serve as the clinical expert on breast cancer, and 
as a liaison to the local, regional, and national CRC resources and expertise, including late 
treatment effect and surgical side effect management.
SUBAWARD: The State University at Buffalo will establish a subaward agreement with the 
University of Rochester (UR), a domestic institution, which will include both personnel and other 
direct costs.  Dr. OJ Sahler at UR will serve as MPI and will be the lead investigator in revising 
Bright IDEAS training materials for the particular population of colorectal cancer survivors and 
their supportive others, training the research assistants in providing the intervention, supervising 
the research assistants on a weekly basis, and performing treatment integrity audits on a random 
sample of audiotapes, which will be obtained for every intervention session.  The following 
personnel will appear in the UR subaward: 

Olle Jane Z. Sahler, MD (MPI)

Patricia Bellohusen, RN (Co-Investigator)

Louis Constine, MD (Co-Investigator)

Fergal Fleming, MD (Co-Investigator)

Barbara Schuman (Project Assistant)

TBN Research Assistants (2)
Olle Jane Sahler, MD (Multiple PI and Subaward PI)
Dr. Sahler is Professor of Pediatrics, Psychiatry, Medical Humanities, and Oncology at the 
University of Rochester.
DUTIES FOR THIS PROJECT: (A) Adaptation of the Bright IDEAS intervention materials for 
use in the colorectal cancer survivor population  (B) Research assistant training in the intervention: 
The Bright IDEAS PSST intervention will be delivered by specially trained research assistants 
(RAs) with background in nursing, behavioral health, or social work (see letter of support from 
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Warner School of Education). Dr. Sahler will use a training protocol she previously developed for 
her earlier studies (NCI R01 CA 159013: Online problem-solving skills training for mothers of 
childhood cancer patients; R25CA183725: Problem-solving skills training for clinicians providing 
psychosocial care in pediatric oncology). The protocol includes a 1.5 day training and follow-up 
case supervision in Problem Solving Skills Training (PSST). We will update the previously 
developed Bright IDEAS training materials and manuals to reflect the unique needs and problems 
of the study population (patients with colorectal cancer). Dr. Sahler will facilitate role playing 
exercises for RAs which will be conducted as a means of training and provide feedback on the 
RAs training and counseling skills. (C) Treatment Integrity Oversight: To assure treatment 
integrity (TI), every session will be audiotaped, identified only by subject code, and uploaded to a 
secure site maintained by the data management center. 20% of the PSST tapes (40 tapes) will be 
chosen at random for review by Dr. Sahler according to a checklist of content items and personal 
responses that have been used for prior projects.  Feedback about any TI concerns will be delivered 
during supervision sessions with the study RAs. (D) Participate in developing the assessment 
battery of onco-behavioral outcomes. (E) Participate in data analysis, interpretation, and 
presentation/publication. Dr. Sahler will work closely with the study team to develop tools to 
optimize assessment of psychosocial distress in cancer survivors and capture changes in their 
emotional state over time.
BACKGROUND and EXPERIENCE: Dr. Sahler is a Behavioral Pediatrician and has specialized 
in the care of chronically and terminally ill children and adolescents for more than 40 years, with 
special emphasis on children with cancer. She has been the Director of Pediatric Psychosocial 
Oncology Services and Research at Golisano Children’s Hospital of Rochester for 20 years and 
medical director of the Childhood Cancer Long-Term Survivors Program for 11 years. Over the 
last 22 years, Dr. Sahler has been sole PI on 4 multisite NCI-funded RCT studies of the Bright 
IDEAS PSST intervention and contact Co-PI on 1 NCI funded R25 focused on the development, 
evaluation, implementation, and dissemination of Bright IDEAS --- including face-to-face, 
telephone-based, and web-based versions ---  and training 200 healthcare professionals in 
delivering the intervention. These experiences and expertise uniquely qualify her for this proposed 
project
Louis S. Constine, MD, Co-Investigator
Dr. Constine is Professor of Radiation Oncology and Pediatrics and Vice Chair of the Department 
of Radiation Oncology, and was awarded fellowship in his professional society, The American 
Society of Radiation Oncology. His clinical and scientific expertise is in lymphomas, sarcomas, 
all pediatric malignancies, and the broad area of Survivorship that includes the acute and chronic 
effects of chemotherapy and radiation therapy on normal tissues. He is the Director of the Judy 
DiMarzo Survivorship Program at the Wilmot Cancer Institute. He is a member or a leader of the 
core committees for the Children’s Oncology Group Survivorship Guidelines, the International 
Survivorship Harmonization Guidelines, the American Society of Clinical Oncology Survivorship 
Advisory Group, and the Pediatric Quantitative Analysis of Normal Tissue Effects in the Clinic 
ASTRO/AAPM initiative, among others. He is recipient of the NIH Merit Award in 2010. He has 
authored (co-authored) more than 50 book chapters, eight books and 175 original and invited 
reports. 
DUTIES FOR THIS PROJECT: Dr. Constine will serve as the Clinical Survivorship Lead on this 
project to facilitate institutional and regional partnerships with clinicians and institutions providing 
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care for cancer survivors. He will also be involved in results interpretation and preparation of the 
future multi-site clinical trial. 
Fergal J. Fleming, MB BCh BAO, MD, FRCS Co-Investigator
Dr. Fleming is a colorectal surgeon and an Assistant Professor of Surgery and Oncology with a 
research interest and expertise in the field of surgical outcomes research with over 50 peer 
reviewed publications in this arena. He is particularly interested in exploring factors associated 
with poor perioperative outcomes following colorectal cancer surgery. In addition to acting as the 
Quality Improvement (QI) liaison for the Division of Colorectal Surgery, he is also a project lead 
with Upstate New York Surgical Quality Improvement Program (UNYSQI).  UNYSQI is a 
collaborative of 15 hospitals in Upstate New York engaged in QI projects for patients undergoing 
colorectal surgery. UNYSQI would offer a wonderful vehicle to test the efficacy of the intensive 
smoking cessation program, should the pilot program demonstrate it to be feasible.
DUTIES FOR THIS PROJECT: Dr. Fleming will serve as the clinical expert on colorectal cancer, 
and as a liaison to the local, regional, and national CRC resources and expertise, including late 
treatment effect and surgical side effect management. He is very excited about being a part of this 
study and exploring the possibility of improving patient adherence to survivorship care plans and 
improving their self-management skills by using PSST.
Thomas Frye, DO, Co-Investigator
Dr. Frye is Assistant Professor of Urology and a Urologic Oncologist who specializes in minimally 
invasive urologic oncology (robotic surgery of bladder, prostate, and kidney cancers), advanced 
open pelvic and retroperitoneal cancer surgery, and detection and management of localized 
prostate cancer with magnetic resonance imaging (MRI). Dr. Frye is one of only a few providers 
in the United States who offers High Intensity Focused Ultrasound (HIFU) - personalized 
treatment of prostate cancer. Dr. Frye is the Chair of GU tumor board at Wilmot Cancer Institute 
and is responsible for GU service line operations, including survivorship consultations and 
referrals.
DUTIES FOR THIS PROJECT: Dr. Frye will serve as the clinical expert on bladder and prostate 
cancers, and as a liaison to the local, regional, and national GI resources and expertise, including 
late treatment effect and surgical side effect management. He is committed to providing high 
quality of care to patients with GU malignancies and improving their self-management skills by 
using PSST.
Patricia Bellohusen, RN, Co-Investigator
Ms. Bellohusen is clinical nurse coordinator for the Judy DiMarzo Cancer Survivorship Program 
at Wilmot Cancer Institute. As the Survivorship Program Coordinator, Ms. Bellohusen 
collaborates with all the various disease clinics in the areas of cancer survivorship, institutionally 
and in the region. She provides leadership in the clinical management of survivors. She also assists 
in the development and implementation of educational resources for survivorship care. She has 
experience and expertise in many areas of oncology and survivorship care including clinical 
guidelines implementation, clinical pathway and documentation development, EHR, caregiver 
involvement, and patient reported outcomes. 
DUTIES FOR THIS PROJECT: On this project, Ms. Bellohusen will work with the study PIs and 
RAs and serve as the Lead Liaison between cancer survivorship services, cancer service lines, 
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social services and community providers to help identify eligible patients and facilitate 
recruitment. 
Other Personnel:
TBA, 2 Research Assistants
The RAs will be Master’s level mental health professionals or doctoral candidates in psychology 
who have completed at least 2 years of study in a counseling-related field (e.g. clinical psychology 
or counseling) or have equivalent experience (see letter of support from Warner School of 
Education). 
DUTIES FOR THIS PROJECT: The Research Assistants will be responsible for patient 
recruitment, training and evaluation. Their careful attention to detail and ability to constructively 
critique issues related to implementation of both forms of PSST will provide useful information 
about how PSST can eventually be delivered in real-life situations at centers with modest 
psychological resources. The RA training will occur at a 1-day workshop before the start of patient 
enrollment. We have conducted 4 similar workshops in support of previous PSST projects, 
resulting in standardized training and enhanced RA understanding of and commitment to the 
project. RAs will be supervised by Dr. Sahler in weekly 2-hour supervision sessions.  The RAs 
will also distribute the study materials (training guide and evaluation forms) to the study 
participants, provide instructions, will be available to answer any questions the patients or 
caregivers may have, collect completed patient evaluation forms, and input data into the REDCap 
database. Together with the study PIs, the RAs will analyze qualitative data to identify trends of 
patient learning and problem-solving patterns in order to evaluate program effectiveness in 
meeting patient needs. For a given study participant, one RA will recruit, assess at time T0 and 
provide all instruction/support for the intervention. The opposite RA will be responsible for 
collecting T1 and T2 assessment materials. This procedure is designed to reduce respondent bias 
due to his/her relationship with the interventionist.  
Barbara Schuman, Project Assistant
Ms. Schuman has provided project related clerical support for Bright IDEAS interventions for 
more than 10 years. She will develop and revise study related printed materials, prepare assessment 
batteries, design and order project-specific supplies, and process reports for publication and 
presentation. 
FACILITIES
THE STATE UNIVERSITY OF NEW YORK (SUNY) AT BUFFALO is New York State’s 
premier public center for graduate and professional education, as well as the State University of 
New York’s (SUNY’s) largest and most comprehensive public university. A member of the 
Association of American Universities (AAU), the University at Buffalo stands in the first rank 
among the nation’s research-intensive public universities. With strengths in medicine, engineering 
and computer science, and public health, the university offers outstanding resources for multi-
disciplinary research and education.
The history of the University at Buffalo’s School of Public Health and Health Professions 
(SPHHP) dates back to Oct. 14, 1965, when the School of Health Related Professions (HRP) was 
created by order of the Trustees of the State University of New York. Albert C. Rekate, MD. The 
next year, UB recruited J. Warren Perry from the Vocational Rehabilitation Administration in 
Washington, D.C., where he had helped shape the 1966 Allied Health Professions Training Act. 
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Perry moved quickly to unify programs in physical therapy, occupational therapy and medical 
technology, all previously housed in the medical school. When HRP was formally dedicated in 
1967, it was the first of its kind in New York and one of the first in the nation.
Since its beginning, SPHHP put a strong emphasis on multidisciplinary cross-institutional 
research and education on the crucial public health issues facing the United States and other 
countries. The SPHHP has full accreditation from the Council of Education for Public Health 
(CEPH). The school's goal is to create an environment in which researchers, educators, public 
health and other health professionals, and students can work together to explore problems and 
produce innovative solutions to address emerging health needs for populations and individuals. 
The school currently has five departments (Biostatistics, Health Behavior, Exercise and Nutrition 
Sciences, Rehabilitation Sciences and Epidemiology and Environmental Health) offering 
undergraduate and graduate degree programs. 
The School occupies approximately 101,000 square feet of university space assigned to the Dean’s 
office, its five departments and research centers.  Currently, the majority of faculty offices are 
located in two buildings (Kimball Tower and Farber Hall) that are in close proximity to each other 
on the University at Buffalo’s South Campus.
Department of Epidemiology & Environmental Health (EEH) has a long tradition of research 
focused on population health and cancer. UB courses in public health, hygiene, sanitation and 
disease prevention date back to the late 1800s. Our department was formally established in 1919 
as the Department of Hygiene and Public Health. Over the years, the name changed to Preventive 
Medicine and Public Health in 1946, to Social and Preventive Medicine in 1967 and in 2014, the 
department became the Department of Epidemiology and Environmental Health. Many 
distinguished researchers contributed to the legacy of EEH, including the late Saxon Graham, PhD, 
one of the fathers of U.S. chronic disease epidemiology and among the first researchers to focus 
on links between diet and the etiology and prevention of cancer and James R. Marshall, PhD, 
senior vice president for cancer prevention and population sciences and chair of the Department 
of Cancer Prevention and Population Sciences at Roswell Park Cancer Institute. 
Extensive facilities are available for all stages of epidemiologic and outcomes research: 
interviewee ascertainment, clinical space for the conducting of interviews and specimen collection, 
facilities for data entry and storage, data processing and for data analysis. Also available are a 
plotter for printing of posters for research presentations, color laser printer and multimedia 
projectors. All major software packages are supported either by the university or by the department 
including SAS®, SPSS®, SPlus, Sudaan®, ARCGIS, Epi-Info™, NCSS, STATA, StatExact, 
LogExact, MINITAB, and nQuery. Numerous data base management systems are also available 
including Access and dBase.
ROSWELL PARK CANCER INSTITUTE (RPCI): Founded in 1898, Roswell Park Cancer 
Institute was the first institution in the world to focus exclusively on cancer research. It grew from 
the vision of Dr. Roswell Park, an eminent surgeon who accurately predicted that cancer would 
become a leading cause of death both in the United States and worldwide. The RPCI campus, 
spread out in 15 separate buildings of approximately two million square feet, occupies 28 acres 
(11 ha) on the 100-acre (40 ha) Buffalo Niagara Medical Campus (BNMC) in downtown Buffalo, 
and includes 1,500,000 square feet (140,000 m2) of space equally distributed between clinical 
programs and research/education functions. A separate hospital building, completed in 1998, 
houses a diagnostic and treatment center. The campus also includes a medical research complex 
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as well as research and education focused space. Research enterprise at RPCI encompasses more 
than 500 research studies that bring over $100 million in grant funding.
RPCI is ranked among the nation's top cancer hospitals by U.S. News & World Report, designated 
as Leapfrog Group Top Hospital, and received Quality Oncology Practice Initiative (QOPI) 
Certification from the American Society of Clinical Oncology (ASCO). RPCI has over 3,000 
employees, including 308 faculty members and 606 nurses. RPCI hospital has 133 licensed 
inpatient beds, provides over 200,000 outpatient visits a year and more than 4,000 surgical 
procedures providing active care to more than 30,000 patients at any time.
Interdisciplinary collaboration and education are essential parts of the experience of working and 
training at Roswell Park Cancer Institute.  Both internal and external experts regularly present their 
latest research, opening up opportunities for learning and collaboration. A sample of these 
activities across the Institute include:

Weekly Population Sciences, Medical and Surgical Grand Rounds presentations

Tumor Immunology & Immunotherapy outside speaker series

Cancer Genetics External Seminar Series

Shashikant Lele Lectureship in Gynecologic Oncology

Cancer Prevention and Control weekly Works-in-Progress and Journal Review Group 
meetings

Disease Site Research Groups (DSRGs): Interdisciplinary groups dedicated to organ site-
specific translational research, clinical research, and the promotion of team science.  
DSRGs include those dedicated to Breast, GI, STM/Dermatology, Thoracic, 
Gynecologic, Head & Neck, Genitourinary, Hem/Onc, and Bone Marrow/Hematopoietic 
Microenvironment.  
The Department of Cancer Prevention and Control, chaired by Christine Ambrosone, PhD, 
includes research that spans the cancer continuum, from understanding the causes of cancer for 
prevention and targeting of high risk populations, to identification of markers for early detection 
and diagnosis, and to understand and prevent factors that impact morbidity and mortality 
associated with cancer diagnosis and treatment. Dr. Noyes is Adjunct Professor in this Department.
The Department of Health Behavior at Roswell Park Cancer Institute is focused on 
understanding all areas of tobacco control. This includes research into the components of tobacco 
products, documenting and understanding tobacco marketing, and influencing and assessing the 
impact of tobacco control policies regionally and nationally. Tobacco use remains the leading 
cause of preventable disease across all population groups, including cancer survivors. The 
Department of Health Behavior houses the Tobacco Cessation Services and Nicotine and Tobacco 
Product Assessment Resource (NicoTAR) which provides instrumentation and services to 
investigators requiring nicotine and tobacco product assessment for their research projects.  
In January 2017, RPCI established the comprehensive multidisciplinary cancer Survivorship 
Program and the Supportive Care Clinical Center (Director: Mary Reid, PhD, Care Coordinator: 
Karen Larkin, NP). The center coordinates services provided by a multidisciplinary team of RPCI 
and community providers to improve quality of life and long-term outcomes of cancer survivors 
in the Buffalo region.
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UNIVERSITY OF ROCHESTER MEDICAL CENTER (URMC): The URMC serves over 
1,000,000 patients annually in Greater Rochester and surrounding communities through its Strong 
Memorial, Golisano Children’s, and Highland Hospitals; James P. Wilmot Cancer Institute; 
Eastman Institute for Oral Health; Visiting Nurse Service of Rochester; regional affiliates; two 
long-term care facilities; and numerous primary care and specialty offices.  This network is 
anchored by Strong—the University’s 800-bed teaching hospital, which consistently ranks among 
“America’s Best Hospitals” (US News & World Report).  The URMC also houses the School of 
Medicine Dentistry (SMD), the School of Nursing, and the Aab Cardiovascular Research Institute. 
The excellence of these programs is reflected in their ability to attract substantial external funding. 
Over the past five years, the SMD has received almost $1.3 billion in research grants. The 
University is the Rochester area’s largest employer and a primary economic driver for our region.  
The URMC has a truly distinguished history of clinical innovation and community partnership 
with highest commitment to clinician education, patient- and family-centered care, and population 
health. This history dates back to Abraham Flexner’s 1910 national report on medical schools, 
which proposed linking medical schools to universities and requiring stricter standards in the 
training of medical students. Those recommendations undergirded the mission of the UR School 
of Medicine when it opened in 1925 with crucial support from philanthropist George Eastman. 
The SMD quickly became a national leader in biomedical research and patient care under its first 
dean, Nobel laureate Dr. George Whipple. 
Strong Memorial Hospital is an 800-bed tertiary care facility, which serves as the primary teaching 
hospital for the University.  It is the only upstate New York hospital to be selected as one of the 
"100 Best Hospitals" in the US.  Strong provides primary, secondary, and tertiary care to over 1 
million people in the 16-county service area.  In that same area, the University of Rochester 
Medical Center (URMC) has approximately 50% cancer market share and is the largest single 
provider.  Moreover, in the largest population center of this region, Monroe County, URMC has 
60 – 70% of all Cancer discharges.  Highland Hospital is a fully affiliated community hospital, 
with focused strengths in geriatric oncology, sarcomas and bone oncology, gynecologic oncology, 
and breast cancer.  Medical research initiatives, including clinical trials, are a cornerstone of the 
University of Rochester School of Medicine.
The URMC has always had a strong commitment to community health. When George Eastman 
pledged his financial support to the URMC in 1920, it was with the proviso that the URMC “make 
Rochester one of the healthiest communities in the world.” Since then, our varied URMC 
departments and centers have independently integrated community health across their education, 
patient care, and research platforms.  We are the birthplace of the biopsychosocial model of care, 
as of numerous other clinical, community, and provider training innovations - including in fields 
of general pediatrics, nursing education, school-based dentistry, patient-centered care, and many 
more. In 2004, in evidence of the URMC’s commitment to community health, the Association of 
American Medical Colleges awarded the UR SMD its prestigious Outstanding Community Service 
Award. In 2006, the Center for Community Health was established to further advance the URMC’s 
community health mission. 
National, regional, and local philanthropy are critical in enabling the URMC to meet its mission 
for community health.  Over the past decade, grants from the Greater Rochester Health Foundation 
have supported the launch and demonstration of novel community health programs, including 
projects for hypertension, depression, stroke, diabetic retinopathy, and other serious illnesses. 
These projects have significantly targeted underserved, low-income, and minority populations, 
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thereby expanding and enhancing the URMC’s and our larger community’s capacity to address 
and redress the problem of ongoing health disparities.
Aside from internal partnerships with URMC centers, the project team has established regional 
and international collaborations with community providers, including with the Upstate New York 
Surgical Quality Initiative (UNYSQI)—a network of 16 hospitals committed to improve the 
quality of care for upstate surgical patients through evidence-based, focused, and measurable best 
practice efforts.  All UNYSQI members are part of the National Surgical Quality Improvement 
Project (NSQIP) supported by the American College of Surgeons (ACS). Additional information 
about the participating community primary care practices is provided in each practice’s Letter of 
Collaboration.
27.0
Prior Approvals
N/A
28.0
Compensation for Research-Related Injury
N/A
29.0
Economic Burden to Subjects
We budget $100 incentive for each patient ($5,000 total) in the form of VISA gift cards to facilitate 
patient recruitment, completion and return of the study evaluation forms and data collection. 
Patients will receive $25 for completing the baseline assessment, another $25 for completing 3-
month assessment and $50 for completing the close-out assessment at about 6 months (including 
semi-structured interviews). Each supportive other will receive $25 gift card for each returned 
evaluation form. Transportation/parking costs and cost of therapy will be covered by the study.
30.0
Consent Process
The survivorship program coordinator (WCI - patients at all locations) and colorectal clinic nurse 
manager (RPCI patients) together with the study RAs will identify adult cancer patients who have 
completed adjuvant treatment for stage I-III cancer and who are eligible for survivorship 
consultation. Two weeks before the scheduled survivorship appointment, the survivorship 
nurse/clinic nurse manager will send the patient a study letter followed by a phone call, telling 
them about the study goals and procedures (e.g., duration of assessment and frequency of follow-
up) and inviting them to participate. Patients who express interest will meet with the study RA in 
the location of their choice (hospital, clinic or patient home). To determine patient eligibility, 
patients will be screened for cancer-related distress using the NCCN Distress Thermometer 
(Appendix 4). Patients who are experiencing psychological distress (NCCN Distress >2 cut-off 
has 100% sensitivity, PROMIS Anxiety >50 or any other clinical measure of mild distress),42 and 
who meet the study’s other inclusion and exclusion criteria (see below) will be invited to 
participate (patient with the distress level 4 or greater will be referred to therapy). If a person is 
willing to continue the screening process by providing written informed consent, he or she will 
then be asked to complete their baseline evaluation consisting of a battery of self-report measures 
(Table 2). The cancer patient will also be asked to identify a Supportive Other (SO) who might 
serve as a problem-solving partner and will undergo the same consent process. Caregivers will be 
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provided with an information sheet describing the research study and their involvement and verbal 
consent to participate will be sought. 
Non-English-Speaking Subjects
Because of the budget constraints (this study is funded by NIH R21 mechanism with budget cap 
of $275K for 2 years) only English-speaking subjects will be eligible for this pilot study.
Waiver or Alteration of Consent Process (consent will not be obtained, required information 
will not be disclosed, or the research involves deception)
Since the study is focused on adults with distress and socio-economic disadvantage and this is a 
minimal risk study, we choose to use a short consent and study information format.
Subjects who are not yet adults (infants, children, teenagers)
N/A
Cognitively Impaired Adults
Because the intervention is a cognitive-behavior therapy, patients who have a prior diagnosis of 
cognitive problems (as documented in EHR) will be excluded from the study.
Adults Unable to Consent
Same as above
31.0
Process to Document Consent in Writing
Eligible patients will initially be contacted by the survivorship nurse/clinic nurse manager who 
will send the patient a study letter followed by a phone call, telling them about the study goals and 
procedures (e.g., duration of assessment and frequency of follow-up) and inviting them to 
participate. Patients who express interest will meet with the study RA in the location of their choice 
(hospital, clinic or patient home). The RA will introduce the study, provide a copy of the consent 
document and answer any questions. After signing the consent, patients will receive a copy of the 
document.
32.0
Drugs or Devices
32.1  
Drugs will not be supplied by the study.
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33.0
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34.0
APPENDICES/SUPPLEMENTS
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