Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer Survivors
Phase: NA
Conditions: Cancer Survivor, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8
Sponsor: Wake Forest University Health Sciences

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
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Principal Investigator: 
 
Stephanie Jean Sohl, PhD, Principal Investigator (PI) 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
 
 
Co-Investigator(s): 
 
Deanna Befus, RN, PhD, Co-Investigator 
Department of Family and Community Medicine 
Center for Integrative Medicine 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
Boris Pasche, MD, PhD, Co-Investigator 
Department of Hematology & Oncology 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
Kathryn Weaver, PhD, MPH, Co-Investigator 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
Kristin Hassmiller Lich, PhD, Consultant  
Department of Health Policy and Management  
Gillings School of Global Public Health  
The University of North Carolina at Chapel Hill  
1105E McGavran-Greenberg Hall, Campus Box 7411  
Chapel Hill, North Carolina 27599-7411 
 
Biostatistician: 
Janet Tooze, PhD, Co-Investigator 
Department of Biostatistical Sciences 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
ClinicalTrials.gov:   
 
 
NCT03520283 
 
 
Regulatory: 
 
 
 
Cindy Miller 
 
 
Participating Institution(s): 
       
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
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Table of Contents 
ABSTRACT ....................................................................................................................................................... 4 
1.0 
Introduction and Background ................................................................................................................. 5 
2.0 
Objectives .............................................................................................................................................. 7 
3.0 
Patient Selection .................................................................................................................................... 7 
3.1 
Inclusion Criteria ................................................................................................................................ 8 
3.2 
Exclusion Criteria ............................................................................................................................... 8 
3.3 
Inclusion of Women and Minorities ..................................................................................................... 8 
4.0 
Registration Procedures ......................................................................................................................... 8 
5.0 
Study Outcomes and Study Measures ................................................................................................... 9 
5.1 
Primary Outcome (Feasibility) ............................................................................................................ 9 
5.2 
Secondary Outcomes ......................................................................................................................... 9 
6.0 
Study-Related Activities ....................................................................................................................... 10 
6.1 
Overview of Study-Related Activities ................................................................................................ 10 
6.2 
Intervention Description .................................................................................................................... 10 
6.3 
General Concomitant Medication and Supportive Care Guidelines .................................................. 11 
6.4 
Duration of Follow Up ....................................................................................................................... 11 
6.5 
Criteria for Removal from Study ....................................................................................................... 11 
7.0 
Adverse Events List and Reporting Requirements ............................................................................... 11 
7.1 
Adverse Event Characteristics ......................................................................................................... 11 
7.2 
STRC SAE Reporting Requirements ................................................................................................ 12 
7.3 
WFUHS IRB AE Reporting Requirements ........................................................................................ 12 
7.4 
Sponsor Reporting Requirements .................................................................................................... 13 
8.0 
Data Management ............................................................................................................................... 13 
9.0 
Statistical Considerations ..................................................................................................................... 13 
9.1 
Analysis of Primary Objective ........................................................................................................... 13 
9.2 
Analysis of Secondary Objectives .................................................................................................... 13 
9.3 
Power and Sample Size ................................................................................................................... 14 
9.4 
Estimated Accrual Rate .................................................................................................................... 14 
9.5 
Estimated Study Length ................................................................................................................... 14 
References ...................................................................................................................................................... 16 
Appendix A – Eligibility Checklist ..................................................................................................................... 19 
Appendix B – Reduced Review** Registration Form ........................................................................................ 20 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
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Appendix C - Race & Ethnicity Verification Form ............................................................................................. 21 
Appendix D – Mandatory STRC SAE Reporting Guidelines ............................................................................. 22 
Appendix E – Adverse Event Log .................................................................................................................... 26 
Appendix F – Study Questionnaires................................................................................................................. 27 
Appendix G – Chart Review Data Collection Form .......................................................................................... 53 
 
 
 
 
 
 
 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
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ABSTRACT 
 
Approximately 66% of those diagnosed with colorectal cancer who will survive for at least 5 years post 
diagnosis need to take a more active role in their care to optimize their health outcomes. Standard care 
includes providing survivorship care plans that initially focused on information delivery alone, which has 
demonstrated limited efficacy for improving health outcomes. An increased emphasis on the process of patient 
engagement and support of non-pharmacologic self-management (SM; symptom management, medication 
adherence, screening, healthy behaviors) is needed to improve care plans. Holistic consideration of individual-
level contextual factors such as values or tradeoffs with existing behaviors, could more sustainably integrate 
SM into survivors’ life context. Facilitating SM with consideration of context is consistent with systems thinking. 
System Support Mapping (MAP) is a systems thinking activity that involves creating a visual diagram of how 
SM occurs within cancer survivors’ life context that facilitates self-awareness and patient-driven engagement in 
SM. We propose to conduct a one-arm pilot study of MAP among 24 colorectal cancer survivors within one 
year of completing active treatment to describe study feasibility, intervention acceptability, and outcome 
variability. MAP can also be a powerful tool to reduce health disparities since it allows for simultaneous 
consideration of individual-level and multi-level contextual factors (i.e., geographic, social, institutional). Health 
disparities exist such that colorectal cancer survivors who are rural residents have higher cancer mortality than 
do urban cancer survivors. Furthermore, rural survivors are at increased risk for self-reported poorer health 
and engage in more health compromising behaviors compared to urban survivors. Therefore, we will also 
identify multi-level contextual factors influencing SM and examine how study results vary by rural-urban context 
to inform future studies. MAP is a novel approach that may generalize to improving care for other chronic 
illnesses such as cardiovascular disease.  
 
 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
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1.0 
Introduction and Background 
 
Cancer survivors need to engage in self-management (SM) to improve health outcomes. Approximately 
66% of the 135,000 people diagnosed with colorectal cancer in the United States each year will survive 
for at least 5 years post diagnosis.1 As cancer survivors are expected to live longer, there is a shift in 
perspective to viewing cancer as a chronic illness, which is accompanied by increased need for cancer 
survivors to partner with physicians and become more actively engaged in SM to optimize their own 
health outcomes.2,3 The Institute of Medicine and others recommend that patients receive a 
comprehensive survivorship care plan when transitioning form active treatment to survivorship that 
provides a treatment summary and outlines follow-up care needs including multiple complex SM 
activities (e.g., psychosocial support, symptom management, health behaviors).3,4 A weakness of initial 
research on survivorship care plans is that interventions have solely focused on information delivery 
and demonstrated limited efficacy for improving self-reported health outcomes.4 Recommended future 
directions for improving upon information-focused survivorship care planning involve increasing the 
emphasis on the process of patient engagement and support of non-pharmacologic SM (e.g., health 
behaviors).4–6 One particularly strong survivorship care planning intervention that improved self-
reported health was designed to be patient-centered and focused on the process of engaging cancer 
survivors with one session that included goal setting, establishing a plan to improve health, and 
increasing the motivation, information, skills, and confidence necessary to engage in SM.6 Yet, this 
intervention focused on survivors’ cancer treatment narrative and did not holistically consider individual-
level contextual factors such as values or tradeoffs with existing behaviors, which would more 
sustainably integrate SM into survivors’ existing life context and ultimately facilitate translation of the 
intervention into practice.7,8  
 
Self-awareness of contextual influences on behavior will engage survivors in sustainable SM. The 
conceptual framework for improving the quality of cancer care presented in an Institute of Medicine 
report starts with engaged patients.9 This report defines patient engagement in cancer care as “A 
system that supports all patients in making informed medical decisions consistent with their needs, 
values, and preferences in consultation with their clinicians who have expertise in patient-centered 
communication and shared decision making.” Self-determination Theory also emphasizes that 
supporting patients’ partnership in healthcare decisions will enhance patients’ engagement in SM and 
ultimately lead to more sustainable improvement in health outcomes.10 According to Self-determination 
Theory, self-awareness is a necessary first step in facilitating patients’ patient-driven (i.e., autonomous) 
motivation for engaging in SM.11 Patient-driven goals are more likely to be achieved than goals that are 
extrinsically motivated.12 This point is illustrated by an intervention to facilitate the SM in other chronic 
diseases that provided participants with the opportunity to self-select their goals rather than prescribing 
specific behavior changes.13 Results showed that this process of patient-driven goal setting 
successfully changed health behaviors and reduced hospitalizations.13 Yet, patients may need 
guidance to facilitate self-awareness and identify what they need to engage in multiple recommended 
SM activities with consideration of their broader life context. 
 
Systems Support Mapping (MAP) facilitates self-awareness of contextual factors. Systems thinking 
unpacks complex behaviors (e.g., SM), while exploring how individual patient choices are facilitated 
and constrained by broader contextual systems.14 System Support Mapping (MAP) is a structured 
systems thinking activity to facilitate survivors’ creation of a visual diagram to tangibly illustrate and 
create self-awareness for how a SM behavior relates to the broader context of tradeoffs with other 
behaviors and achieving most-valued outcomes. MAP facilitates self-awareness of the complex broader 
system and the ability for patients to clearly identify any discrepancies or intervention targets for SM. 
Highlighting discrepancies between current and desired states is used as a technique to generate 
patient-driven motivation for behavior change.15,16 Tying individual SM behaviors to broader life values 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
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may also increase the perceived importance of SM goals and thus patient engagement. Similarly, 
identifying how changing SM holistically affects broader contextual systems will more sustainably 
integrate SM. Having patients select patient-driven goals for SM with a consideration of their life context 
will set the stage for engaging in patient-driven SM. MAP has primarily been applied to systems in the 
community setting with the exception of Dr. Befus’ (Co-Investigator) work in collaboration with Dr. Lich 
(Consultant) that took an individual-focused approach to understanding SM and health equity in women 
with migraine occupying lower social locations.17 Thus, it is novel to apply an individual-focused MAP to 
guide patient engagement in SM with a focus on non-pharmacologic approaches during the transition 
from active cancer treatment to survivorship.    
 
MAP can be a powerful tool to reduce health disparities since it allows for simultaneous consideration 
of (1) individual-level and (2) multi-level contextual factors.14,18 Rural cancer survivors’ are especially 
likely to benefit from guidance to facilitate self-awareness and select patient-driven goals due to their 
need to consider complex multi-level contextual factors (i.e., geographic, social, institutional).18,19 For 
example, geographic context is associated with the ability to access to supportive care services (e.g., 
psychologist, religious leader).19–21 Rural residents may share a social context such as the importance 
of self-reliance.19 Furthermore, results from our research and others show that a large portion (30-40%) 
of cancer survivors seek methods for SM outside of conventional cancer care institutions through 
means such as use of complementary health approaches (CHA) at higher rates than the general 
public22–24 and use of CHA is higher in rural communities.25,26 Thus, interventions are needed that 
consider multi-level contextual factors in order to optimize SM and address rural-urban disparities in 
health outcomes.27 Health disparities exist such that colorectal cancer survivors who are rural residents 
have higher cancer mortality than do urban cancer survivors.28 Furthermore, rural survivors are 
generally at increased risk for self-reported poorer health (e.g., psychological distress, symptoms) and 
engage in more health compromising behaviors (e.g., smoking and physical inactivity) compared to 
urban survivors.27 Such health compromising behaviors are associated with mortality.29 MAP may 
improve individual-level SM, while also identifying how individual-level SM interacts with multi-level 
contextual factors associated 
with rural-urban disparities 
(e.g., education, travel 
barriers).27 Additionally, MAP 
will identify key stakeholders 
and leverage points needed 
to inform future multi-level 
studies.17 Figure 1 shows the 
proposed conceptual model, 
which places Self-
Determination Theory in 
context of other factors 
influencing patient-centered 
care and health 
disparities.9,18,30–32  
 
 
 
 
 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
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2.0 
Objectives 
 
We will conduct a one-arm pilot study of MAP among 24 colorectal cancer survivors within one year of 
completing active treatment. We will quantitatively and qualitatively describe recruitment and retention; 
intervention completion and acceptability; and variability and changes in proposed outcomes (i.e., 
measures of patient engagement, health outcomes) to guide future study planning. We will analyze 
collected maps, and describe factors and targets for intervention at multiple levels 
(individual/geographic/social/institutional). 
 
2.1 Primary Objective 
 
2.1.1 To evaluate the feasibility of the MAP intervention in colorectal cancer survivors, as 
characterized by enrollment, intervention adherence, and retention rates.  
 
We hypothesize >50% of eligible patients will enroll and that >70% of participants will complete 
the intervention and be retained in the study.  
 
2.2 Secondary Objectives 
 
2.2.1 To evaluate intervention acceptability as characterized by participant ratings. 
 
2.2.2 To describe outcome variability to inform future studies. 
 
2.2.3 To identify multi-level contextual factors influencing SM.  
 
2.2.4 To qualitatively assess feasibility, acceptability using semi-structured interviews. 
 
2.2.5 To examine how study results vary by rural-urban context.  
3.0 
Patient Selection 
 
We will enroll 24 participants with equal numbers of patients from urban and rural communities over 10 
months. To identify potential patients, programming with Epic will be used to provide automated reports 
identifying patients within one year of completing active treatment for colorectal cancer. We will also 
post the study on Be Involved. The Project Manager will screen the report and communicate with 
attending physicians, physician assistants, clinic nurses and/or the patient navigator regarding patients’ 
potential eligibility for the study. Research staff will approach patients either in person or remotely (e.g., 
telephone, myWakeHealth, mail) regarding their interest in study participation. Ways to contact the 
study team if they wish to opt out of the study will be included. A study team member will then follow up 
with all patients who respond to the letter with an interest in participation. Of the patients who do not 
decline, the study coordinator will approach at their next clinic visit or by phone to provide study 
information and answer questions to determine willingness to participate. The consent will be signed 
remotely or in person. If signed remotely, patients will be asked to send the form back to us by a secure 
means (e.g., REDCap, mail). In the case that the patient is consented remotely, either a hard copy or 
email attachment of the informed consent document will be provided to the participant. We will 
compensate participants $50. 
 
We will document recruitment in a Screening Log including reasons for ineligibility, eligible patients 
approached, number who declined participation, and number successfully recruited. After making sure 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
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the patient clearly understands the study procedures and agrees to follow them, the patient will be 
asked to sign the informed consent form. A copy of the consent form will be given to the participant, 
and the original copy will be kept in the participant’s file.  
3.1 
Inclusion Criteria  
 
3.1.1 Adults ≥18 years of age  
 
3.1.2 Diagnosed with stage I-III colorectal cancer 
 
3.1.3 Within 2 years of completing active treatment for colorectal cancer  
 
3.1.4 Cognitively able to complete interviews as judged by the study team 
 
3.1.5 Able to understand, read and write English 
 
Children under the age of 18 with colorectal cancer will be excluded due to the rarity of 
colorectal cancer in this population according to the National Cancer Institute (incidence rate ≤ 
0.6) and because they are likely to have distinct needs and experiences if diagnosed this young. 
Further, it is unlikely that the study would recruit sufficient numbers in this subset of the cancer 
survivor population to gain meaningful results. Results from this research may inform future 
studies in children with cancer under 18 who are generally different from adults and should be 
researched separately.  
3.2 
Exclusion Criteria  
 
 
 
 
 
3.2.1 Declined participation in the study 
3.3 
Inclusion of Women and Minorities 
 
The target population for this study is adult men and women who have completed active 
treatment for colorectal cancer. We expect that women and minorities will be represented as is 
consistent with the proportion seen in the past five years at the Wake Forest Baptist 
Comprehensive Cancer Center. For this pilot study, non-English speaking patients will be 
excluded because the intervention will be implemented in English. Pending results of the pilot, a 
future study to determine the efficacy of translating the intervention will be proposed. Experts at 
Wake Forest Baptist Comprehensive Cancer Center’s Office for Cancer Health Equity will 
review our protocol and suggest additional strategies to enhance the ability to recruit a 
representative sample. The OCHE includes a Hispanic Clinical Trial Patient Navigator who 
provides guidance to Hispanic participants throughout the research process and will be involved 
in educating any potential Hispanic study participants on clinical trials prior to in-person 
interaction with the Project Manager. The intervention is designed to reduce barriers to 
recruitment and to be presented in a manner that will be culturally sensitive with the aim of 
reaching all patients.  
4.0 
Registration Procedures 
 
All patients entered on any WFBCCC trial, whether treatment, companion, or cancer control trial, must 
be linked to the study in EPIC within 24 hours of Informed Consent. Patients must be registered prior to 
the initiation of treatment.   

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
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You must perform the following steps in order to ensure prompt registration of your patient: 
 
1. Complete the Eligibility Checklist (Appendix A) 
2. Complete the Protocol Registration Form (Appendix B) 
3. Alert the Cancer Center registrar by phone, and then send the signed Informed Consent Form, 
Eligibility Checklist and Protocol Registration Form to the registrar, either by fax or e-mail. 
 
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-Friday. 
 
4. Fax/e-mail ALL eligibility source documents with registration. Patients will not be registered without 
all required supporting documents. 
Note: If labs were performed at an outside institution, provide a printout of the results. Ensure that the 
most recent lab values are sent. 
 
To complete the registration process, the Registrar will:   
 
 
assign a patient study number 
 
register the patient on the study 
5.0 
Study Outcomes and Study Measures 
 
We will collect data at two different levels, the individual-level (feasibility, outcome measures), and 
multi-level contextual factors (MAP data). We will collect self-reported data either remotely or in person 
at baseline and two weeks after MAP.  
 
5.1 Primary Outcome (Feasibility) 
 
Enrollment rate will be calculated as the percent of eligible participants approached who agree to 
participate. 
 
Participation rate will be calculated as the percent of participants who complete the study intervention 
among those enrolled.  
 
Retention rate will be calculated as the number of participants who complete the study measures 
among those enrolled. 
 
5.2 Secondary Outcomes 
 
5.2.1 Self-reported ratings of intervention acceptability  
 
5.2.2 Proximal outcomes 
5.2.2.1 
Measures of autonomy [Index of Autonomous Functioning]33  
5.2.2.2 
Self-efficacy for managing cancer [Self-efficacy to Manage Chronic Disease Scale 
and PROMIS self-efficacy for managing symptoms short form]34–36  
5.2.2.3 
Relatedness [HEAL Patient-Provider Connection],37 only assessed at follow-up 
because this construct is assessing the experience with the MAP facilitator. 
 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
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5.2.3 Health outcomes 
5.2.3.1 
Psychological stress [Perceived Stress Scale, 4-item]38 
5.2.3.2 
Symptoms [PROMIS Profile 29]39  
5.2.3.3 
Health behaviors [items on tobacco use, physical activity, use of CHA]22  
 
5.2.4 Qualitative assessment of feasibility, acceptability and changes in outcomes with semi-
structured interviews 
 
5.2.5 Qualitative analysis of systems support maps  
 
5.2.6 Demographic (age, rural-urban residence [classified by the Federal Office of Rural Health 
Policy definition of rural],40 race/ethnicity, marital status, education level, health literacy,41 
financial toxicity42)  
 
5.2.7 Clinical factors (cancer type, disease stage, recurrence status, type of treatment) factors will be 
abstracted from medical charts or self-reported.  
6.0 
Study-Related Activities 
6.1 Overview of Study-Related Activities  
 
a Pre-study requirements listed in table must be completed within 30 days prior to registration. 
b MAP = Systems Support Mapping 
c Intervention may be coordinated with future clinic visit; must be completed within 6 months of registration 
d Follow-up visit to be completed 14 - 28 days after intervention 
6.2 Intervention Description 
 
Systems Support Mapping (MAP) Intervention. The intervention will be implemented individually to 
outpatients. Trained facilitators will guide participants to create a visual diagram of their SM activities 
within their broader life context (MAP). MAP helps participants tangibly see complex SM activities on 
paper, which makes them more actionable. MAP was acceptable to participants in our preliminary work, 
which included social and economically marginalized women.17 Each participant will be provided with a 
piece of poster-sized paper with five concentric circles on it and six pads of differently-colored sticky 
notes used to represent different rings. Participants will begin by identifying the most important aspects 
 
Pre-Studya 
Baseline 
MAP b Interventionc 
Follow-up (2-week)d 
Recruitment 
X 
 
 
 
Informed consent 
X 
 
 
 
Demographic and Clinical Factors 
 
 
X 
 
 
Patient-Reported Outcomes 
 
 
X 
 
X 
Intervention Completion 
 
 
 
X 
 
Acceptability Ratings 
 
 
 
X 
Semi-structured Interview 
 
 
 
X 
Adverse event evaluation 
 
 
 
X 
X 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
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of life that having cancer is preventing them from experiencing. Each resulting MAP will describe 
participants’ most bothersome life impacts of cancer, SM activities with a focus on non-pharmacologic 
approaches, facilitators and needs for SM, and outcomes and tradeoffs of SM. We will ask participants 
to reflect aloud, discuss any discrepancies between current and desired outcomes of SM, and 
brainstorm about what they need to reconcile them. We will then have participants identify one goal that 
is important and achievable in the next two weeks and set action steps.43 Dr. Befus (Co-Investigator) 
will train study staff who have experience with conducting qualitative research (Q-PRO staff) to facilitate 
MAPs. MAP will take 60-90 minutes, be digitally recorded, and transcribed to ensure treatment fidelity 
and facilitate analysis. Participants will be off-treatment upon completion of this one session. 
 
Reported adverse events and potential risks are described in Section 7. 
 
6.3 General Concomitant Medication and Supportive Care Guidelines 
 
This behavioral intervention will not affect usual care. 
6.4 Duration of Follow Up 
 
Patients will be followed for two weeks after this minimal-risk behavioral intervention is administered for 
adverse events monitoring. Follow-up for serious adverse events and mortality after the intervention is 
implemented will take place during the routine clinic visits that the patient will have during the 2 follow-
up window (also referenced in Appendix D). If no visit occurs during this window, a phone call 
confirmation should be made to the patient to determine vital status and whether any adverse events 
and in particular, Grade 4 unexpected and Grade 5 adverse events occurred during that window of time 
and recorded on Appendix E.   
6.5 Criteria for Removal from Study 
 
There are no additional criteria for removal from the study. 
7.0 
Adverse Events List and Reporting Requirements 
 
Expected adverse experiences for the study intervention are as follows: 
 
Emotional distress (i.e., mild anxiety or mild depressive symptoms) 
 
Each interventionist will monitor and note any adverse events experienced during the MAP session 
(e.g., patients’ expression of emotional distress, request to discontinue the session).  The study 
team will only document adverse events during the two-week period following the intervention. 
 
7.1 Adverse Event Characteristics 
 
 
CTCAE term (AE description) and grade:  The descriptions and grading scales found in the 
revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be 
utilized for AE reporting. All appropriate treatment areas should have access to a copy of the 
CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP 
web site (http://ctep.cancer.gov). 
 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
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 
‘Expectedness’: AEs can be ‘Unexpected’ or ‘Expected’ (see Section 7.1 above) for 
expedited reporting purposes only.   
 
 
Attribution of the AE: 
 
- 
Definite – The AE is clearly related to the study treatment. 
- 
Probable – The AE is likely related to the study treatment. 
- 
Possible – The AE may be related to the study treatment. 
- 
Unlikely – The AE is doubtfully related to the study treatment. 
- 
Unrelated – The AE is clearly NOT related to the study treatment. 
 
7.2 STRC SAE Reporting Requirements 
 
The Safety and Toxicity Reporting Committee (STRC) is responsible for reviewing SAEs for WFBCCC 
Institutional studies as outlined in Appendix D. STRC currently requires that all unexpected 4 and all 
grade 5 SAEs on these trials be reported to them for review. All WFBCCC Clinical Research 
Management (CRM) staff members assisting a Principal Investigator in investigating, documenting and 
reporting an SAE qualifying for STRC reporting are responsible for informing a clinical member of the 
STRC as well as the entire committee via the email notification procedure of the occurrence of an SAE.  
7.3 WFUHS IRB AE Reporting Requirements 
 
Any unanticipated problems involving risks to subjects or others and adverse events shall be promptly 
reported to the IRB, according to institutional policy. Reporting to the IRB is required regardless of the 
funding source, study sponsor, or whether the event involves an investigational or marketed drug, 
biologic or device. Reportable events are not limited to physical injury, but include psychological, 
economic and social harm. Reportable events may arise as a result of drugs, biological agents, 
devices, procedures or other interventions, or as a result of questionnaires, surveys, observations or 
other interactions with research subjects. 
 
All members of the research team are responsible for the appropriate reporting to the IRB and other 
applicable parties of unanticipated problems involving risk to subjects or others. The Principal 
Investigator, however, is ultimately responsible for ensuring the prompt reporting of unanticipated 
problems involving risk to subjects or others to the IRB. The Principal Investigator is also responsible 
for ensuring that all reported unanticipated risks to subjects and others which they receive are reviewed 
to determine whether the report represents a change in the risks and/or benefits to study participants, 
and whether any changes in the informed consent, protocol or other study-related documents are 
required. 
 
Any unanticipated problems involving risks to subjects or others occurring at a site where the study has 
been approved by the WFUHS IRB (internal events) must be reported to the WFUHS IRB within 7 
calendar days of the investigator or other members of the study team becoming aware of the event. 
 
Any unanticipated problems involving risks to subjects or others occurring at another site conducting 
the same study that has been approved by the WFUHS IRB (external events) must be reported to the 
WFUHS IRB within 7 calendar days of the investigator or other members of the study team becoming 
aware of the event. 
Any event, incident, experience, or outcome that alters the risk versus potential benefit of the research 
and as a result warrants a substantive change in the research protocol or informed consent 
process/document in order to insure the safety, rights or welfare of research subjects. 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
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7.4 Sponsor Reporting Requirements  
 
There are no additional sponsor reporting requirements. 
8.0 
Data Management 
 
Informed consent document 
EPIC 
Decline Forms 
REDCap 
Screening Log 
File on a Secure Server 
Protocol Registration Form 
WISER/OnCore 
Demographic and Clinical Factors 
REDCap 
Patient-reported Outcomes 
REDCap 
Intervention Completion Form 
REDCap 
Intervention MAP 
Files on a Secure Server 
Semi-structured Interview 
Files on a Secure Server 
Adverse Events Log 
WISER/OnCore 
9.0 
Statistical Considerations 
 
9.1 Analysis of Primary Objective 
 
 
9.1.1 We will use one-sample tests of negative binomial probabilities and binomial proportions to 
compare rates of feasibility to hypothesized values. Rates will be summarized using point 
estimates and 95% confidence intervals. In exploratory analyses, we will compare participants’ 
intervention completion and retention by baseline characteristics using chi-square tests and t-
tests.  
9.2 Analysis of Secondary Objectives 
 
To meet Objective 2.2.1, we will use descriptive statistics to summarize participant ratings of 
acceptability.  
 
Descriptive statistics (means, standard deviations, 95% confidence intervals) will be used to 
summarize proximal outcomes and change in health outcomes by assessment measure to meet 
Objective 2.2.2. The primary interest will be in estimating the variance for use in planning future 
studies.  
 
For Objective 2.2.3, the internal study team will work with external collaborators through an 
iterative process to facilitate a qualitative content analysis44 of the large quantity of textual MAP 
data. Specifically, we will first enter text data from the completed paper maps into a software 
program co-developed by Steve Chall (external Senior Programmer, University of North 
Carolina-Chapel Hill Renaissance Computing Institute) and Dr. Lich (Consultant) using the ssm 
function to create a digital map.17,45 Steve Chall will translate the text MAP data into lists that 
can be sorted by the study team (using the sort program). The sort program will allow us to 
group and code similar terms or concepts. Next, we will send our sort files back to Steve Chall 
and he will use Python programming language to help aggregate the large amounts of textual 

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data into formats we can manipulate (Python Software Foundation, 2017). These matrices will 
be saved in the form of Excel (.csv) files, which are compatible with other statistical software. 
We will ultimately present resulting counts and descriptive statistics of findings alongside 
descriptive categories and themes.  
 
To meet Objective 2.2.4, we will also conduct a qualitative content analysis.44 Qualitative data 
will be sent to an external vendor to be transcribed. Two internal study team members will 
double-code at least 10% of coding of transcripts from the semi-structured interviews and 
resolve any disagreements to ensure that we achieve robust and unbiased results. We will 
evaluate qualitative and quantitative analyses in a mixed-methods framework for consistency 
and discrepancies across all analyses to refine the protocol.  
 
To meet Objective 2.2.5, we will examine all quantitative and qualitative analyses by urban-rural 
status as classified using the Federal Office of Rural Health Policy definition of rural.40 For 
quantitative measures, we will compute descriptive statistics by urban-rural status and will use 
Fisher’s exact tests and Wilcoxon rank sum tests to compare urban and rural participants. 
Qualitative results will be summarized by urban-rural status. We will also compare MAP results 
by rural-urban status.  
 
9.3 Power and Sample Size 
 
The target sample size is based on estimating rates of feasibility measures to inform the design 
of an efficacy trial. If the recruitment rate is below 50% and intervention completion and 
retention rates are below 70%, a larger study may not be feasible. Assuming a negative 
binomial distribution and true rate of 50%, the probability that we would have to approach 61 or 
more people to recruit 24 is <0.05. Therefore, if we approach ≥61 participants to enroll 24, it is 
unlikely the true probability is above 50%, and we will conclude the study may not be feasible. 
Out of the 24 participants, if the true rate of intervention completion and study retention is 70%, 
we expect 13 or more will participate/be retained, so if 12 or fewer do not participate/are not 
retained the study may not be feasible; we have 80% power to test that the hypothesis that the 
rate is 70% compared to the alternative that is 46% or less. The number of participants 
interviewed  will be determined when theoretical saturation is reached. We estimate that we will 
need 8-12 participants in each group (rural-urban).46 
9.4 Estimated Accrual Rate 
 
We will enroll 24 participants over 10 months at a rate of 3 participants per month. We expect 
this rate to be feasible since the Wake Forest Baptist Comprehensive Cancer Center 
(WFBCCC) sees approximately 60 patients with colorectal cancer who initiate chemotherapy 
each year and thus approximately the same number will be within a year of completing 
treatment when the study begins (plus a potential 5 per month after that who complete 
treatment and become eligible). Our study team (i.e., Dr. Sohl, Dr. Tooze, and  Meg O’Mara) 
has experience working together to recruit patients diagnosed with colorectal cancer and 
conducting behavioral intervention research. Over 75% of patients approached have agreed to 
participate in our current behavioral intervention study in colorectal cancer patients initiating 
active treatment (K01 AT008219; PI: Sohl). The proposed research is less time sensitive and 
intensive for participants than the current study, so we expect to have similar success.  
9.5 Estimated Study Length 
 

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We expect the study to be completed in approximately one year (by April, 2019). 
 
 

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20 Butow PN, Phillips F, Schweder J, White K, Underhill C, Goldstein D, et al. Psychosocial well-being and 
supportive care needs of cancer patients living in urban and rural/regional areas: a systematic review. 
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010-0153-7. 
25 Herron M, Glasser M. Use of and Attitudes Toward Complementary and Alternative Medicine Among Family 
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26 Adams J, Sibbritt D, Lui C-W. The urban-rural divide in complementary and alternative medicine use: a 
longitudinal study of 10,638 women. BMC Complement Altern Med 2011;11:2. https://doi.org/10.1186/1472-
6882-11-2. 
27 Weaver KE, Geiger AM, Lu L, Case LD. Rural-urban disparities in health status among US cancer survivors. 
Cancer 2013;119:1050–7. https://doi.org/10.1002/cncr.27840. 
28 Singh GK, Williams SD, Siahpush M, Mulhollen A. Socioeconomic, Rural-Urban, and Racial Inequalities in 
US Cancer Mortality: Part I-All Cancers and Lung Cancer and Part II-Colorectal, Prostate, Breast, and 
Cervical Cancers. J Cancer Epidemiol 2011;2011:107497. https://doi.org/10.1155/2011/107497. 
29 Van Blarigan EL, Meyerhardt JA. Role of physical activity and diet after colorectal cancer diagnosis. J Clin 
Oncol 2015;33:1825–34. https://doi.org/10.1200/JCO.2014.59.7799. 
30 Williams GC, Minicucci DS, Kouides RW, Levesque CS, Chirkov VI, Ryan RM, et al. Self-determination, 
smoking, diet and health. Health Educ Res 2002;17:512–21. https://doi.org/10.1093/her/17.5.512. 
31 Epstein RM, Street RL. Patient-Centered Communication in Cancer Care: Promoting Healing and Reducing 
Suffering. Bethesda, MD: National Cancer Institute, NIH Publication No. 07-6225; 2007. 
32 Sohl SJ, Birdee G, Elam R. Complementary tools to empower and sustain behavior change: Motivational 
interviewing and mindfulness. Am J Lifestyle Med 2016;10:429–36. 
https://doi.org/10.1177/1559827615571524. 
33 Weinstein N, Przybylski AK, Ryan RM. The index of autonomous functioning: Development of a scale of 
human autonomy. J Res Personal 2012;46:397–413. https://doi.org/10.1016/j.jrp.2012.03.007. 
34 Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were 
validated using multiple studies. J Clin Epidemiol 2014;67:1265–73. 
https://doi.org/10.1016/j.jclinepi.2014.06.009. 
35 Moore SM, Schiffman R, Waldrop-Valverde D, Redeker NS, McCloskey DJ, Kim MT, et al. 
Recommendations of Common Data Elements to Advance the Science of Self-Management of Chronic 
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https://doi.org/10.1111/jnu.12233. 
36 Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS®measures of self-efficacy 
for managing chronic conditions. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 2017;26:1915–24. 
https://doi.org/10.1007/s11136-017-1527-3. 
37 Greco CM, Yu L, Johnston KL, Dodds NE, Morone NE, Glick RM, et al. Measuring nonspecific factors in 
treatment: item banks that assess the healthcare experience and attitudes from the patient’s perspective. 
Qual Life Res 2016;25:1625–34. https://doi.org/10.1007/s11136-015-1178-1. 
38 Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 
1983;24:385–96. 

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39 Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient-Reported Outcomes 
Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported 
health outcome item banks: 2005-2008. J Clin Epidemiol 2010;63:1179–94. 
https://doi.org/10.1016/j.jclinepi.2010.04.011. 
40 Health Resources and Services Administration. Defining Rural Population. Defining Rural Population. 2017. 
URL: https://www.hrsa.gov/rural-health/about-us/definition/index.html (Accessed 4 June 2019). 
41 Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD. Brief report: screening items to identify patients 
with limited health literacy skills. J Gen Intern Med 2006;21:874–7. https://doi.org/10.1111/j.1525-
1497.2006.00532.x. 
42 de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araújo FS, Hlubocky FJ, et al. Measuring financial toxicity 
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Toxicity (COST). Cancer 2017;123:476–84. https://doi.org/10.1002/cncr.30369. 
43 Williams DA, Carey M. Solving the Problems of a Chronic Illness: Six-step Problem Solving. University of 
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45 Chall S. Chapel Hill, NC: Renaissance Computing Institute; 2017. 
46 Guest G, Bunce A, Johnson L. How many interviews are enough?: An experiment with data saturation and 
variability. Field Methods 2006;18:59–82. https://doi.org/10.1177/1525822X05279903. 
 
 
 
 
 

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Appendix A – Eligibility Checklist 
 
 
IRB Protocol No. 00048866 
WFBCCC Protocol No. 99118 
Study Title: Use of Systems Support Mapping to Guide Patient-Driven Self-Management in Rural and Urban Cancer 
Survivors 
Principal Investigator:  Stephanie Jean Sohl, PhD 
 
Inclusion Criteria 
(as outlined in study protocol) 
Criteria 
is met 
Criteria is 
NOT met 
Source Used to Confirm * 
(Please document dates and lab results) 
Adults ≥18 years of age  
□ 
□ 
 
Diagnosed with stage I-III colorectal cancer 
□ 
□ 
 
Within 2 years of completing active treatment for 
colorectal cancer 
□ 
□ 
 
Cognitively able to complete interviews as judged 
by the study team 
□ 
□ 
 
Able to understand, read and write English 
□ 
□ 
 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria is 
present 
Source Used to Confirm * 
(Please document dates and lab results) 
Declined study participation  
□ 
□ 
 
 
This subject is      
 eligible /  ineligible     for participation in this study. 
 
OnCore Assigned PID: ___ ___ ___ ___ ___ ___ ___ ___  
 
 
 
 
 
 
 
 
Signature of research professional confirming eligibility: _______________________  
 
Date: ___ ___ / ___ ___ / ___ ___ 
 
 
* Examples of source documents include clinic note, pathology report, laboratory results, etc. When listing the source, 
specifically state which document in the medical record was used to assess eligibility. Also include the date on the 
document. Example: “Pathology report, 01/01/14” or “Clinic note, 01/01/14” 
 
 

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Appendix B – Reduced Review** Registration Form 
 
DEMOGRAPHICS 
Patient: Last Name: _____________________ First Name: ___________________________ 
MRN:          ___ ___ ___ ___ ___ ___ ___ ___ ZIPCODE: ___ ___ ___ ___ ___ 
  
 
 
 
*SEX:   
  Male      Female 
 
 
*Ethnicity (choose 
one):   
 Hispanic        Non-Hispanic 
 
*Race (choose all that 
apply): 
 WHITE        African American            
 ASIAN          PACIFIC ISLANDER                 
 NATIVE AMERICAN (Alaskan) 
*Diagnosis: ____________________________________________________________ 
DOB (mm/dd/yy): ___ ___ / ___ ___ / ___ ___ (include if no MRN is provided) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Comprehensive Cancer Center requires that all registrations be sent to the CCCWFU Centralized Registrar the day the patient 
is consented; if this is not possible we require that all registration be communicated to the Centralized Registrar within 72 hours 
by the CRM registrar. 
 
**Reduced Review means eligibility and other review are not performed by CRM registrar. 
 
For questions, the Protocol Registrar can be contact between 8:30 AM and 4:00 PM, Monday – Friday. 
 
Completed Eligibility Checklist and Protocol Registration Form must be hand delivered, faxed or e-mailed to the registrar  
 
*** if not using the full wakehealth.edu outlook client (full outlook, not web outlook) save this file and attach to an email. 
 
 
 
 
*MD Name (Last, First) : 
______________________, _________________________      
*Date Consent Signed: 
___ ___ / ___ ___ / ___ ___ 
 
Date of Registration: (if different than 
consent signing) 
___ ___ / ___ ___ / ___ ___ 
PID # (OnCore): 
___ ___ ___ ___ ___ ___ ___ ___ (to be completed by registrar) 
 

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Appendix C - Race & Ethnicity Verification Form 
 
Thank you so much for helping us to verify your race and ethnicity to ensure the quality of our 
information. As a brief reminder, the information you provide today will be kept confidential. 
 
1. Are you: 
Hispanic or Latino/a 
Not Hispanic or Latino/a 
 
2. What is your race? One or more categories may be selected. 
White or Caucasian 
Black or African American 
American Indian or Alaskan Native 
Asian 
Native Hawaiian or Other Pacific Islander 
Other, Please Specify: ___________________________ 
          
      
 
 
 
 
 
 
 
 
 
Internal use only: 
 
 
 Name: ____________________ MRN#: ____________________  
 
Was the self-reported race and ethnicity of the participant verified at the time of consent? 
Yes        No 
 
Was a discrepancy found?       Yes         No 
         If yes, please provide what is currently indicated in the EMR:  
 
 
Ethnicity: ____________________  
Race: ____________________ 
Additional comments: __________________________________________________________________ 
_____________________________________________________________________________________ 
_____________________________________________________________________________________

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Appendix D – Mandatory STRC SAE Reporting Guidelines 
Safety and Toxicity Review Committee (STRC; 
previously known as CROC)  Serious Adverse 
Event (SAE) Notification SOP 
     Date: 2/2/2018 
 
 
Mandatory STRC SAE Reporting Requirements in WISER 
 
All AEs and SAEs that occur on any CCCWFU Institutional Interventional trial must be entered into the 
WISER system.  Once these AEs and SAEs are entered, the following document describes how to initiate 
STRC reporting using the SAE form in WISER that is submitted for unexpected grade 4 and any grade 5 
(death during protocol intervention) SAEs on CCCWFU Institutional interventional trial patients. There 
are multiple entities that require reporting of SAEs. Each entity has different rules for what is reported, 
and how it is reported.    
Rules used by other entities (Institutional Review Board (IRB), AdEERS, MedWatch, etc.) should NOT be 
used to evaluate whether an event should be reported to STRC. Only the rules for reporting described in 
this document should be considered. 
 
As defined in the NCI Data Table 4 reporting guidelines, CCCWFU Institutional Interventional studies 
covered by these reporting requirements are defined as: In-house, internally reviewed trials, including 
those collaborative studies conducted with industry sponsorship in which the center is a primary 
contributor to the design, implementation, and monitoring of the trial, or participation in a multi-site 
trial initiated by an institutional investigator at another center.  Institutional trials are almost always 
authored by a researcher here at CCCWFU. Cooperative group protocols are not considered 
Institutional, but Research Base trials are classified as Institutional. 
 
The STRC is responsible for reviewing SAEs for CCCWFU Institutional Interventional studies, as defined 
above. STRC currently requires that unexpected grade 4 and all grade 5 SAEs on these trials be reported 
to the STRC for review. All staff members assisting a PI in documenting and reporting an SAE that qualifies 
for STRC reporting are responsible for informing a clinical member of the STRC by phone (or in-person), 
followed by informing the entire committee via the required email notification. 
 
THESE REPORTING REQUIREMENTS APPLY TO any faculty or staff member on the study team for a 
CCCWFU Institutional Interventional trial. Ultimately, the protocol PI has the primary responsibility for 
AE identification, documentation, grading and assignment of attribution to the investigational 
agent/intervention.  However, when an SAE event as described below is observed, it is the responsibility 
of the person who observed the event to be sure that it is reported to the STRC. 
 
What is considered an SAE under this mandatory procedure? 
Any unexpected grade 4 event and all grade 5 events (death during protocol intervention) should be 
reported. These events should be reported if they occur while a patient is on study treatment or if they 
occur within 30 days of last study treatment (even if patient begins a new treatment during the 30 days). 
This window of 30 days should be the standard window to be used in all protocols unless a specific 
scientific rationale is presented to suggest that a shorter window can be used to identify events.  In 
addition, if it is not clear whether the Grade 4 is unexpected it should be reported. 
 

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Table 1: Summary of STRC Reporting Requirements for Institutional Pilot, Phase 1, Phase 2  
and Phase 3 Interventional Trials  
 
STRC reporting may not be appropriate for specific expected adverse events for protocols. In those 
situations the adverse events that will not require STRC reporting must be specified in the text of the 
approved protocol. 
 
STRC notification responsibilities of the person (e.g., nurse) handling the reporting/documenting of 
the SAE in WISER: 
 
1. Make a phone call (or speak in person) to the appropriate clinical member of the STRC as listed 
below (page if necessary)—see note 2 below 
2. Enter a new SAE into the SAE module that is located in the Subject>> CRA Console in WISER 
WITHIN 24 HOURS of first knowledge of the event. Information can be entered and saved, but 
the STRC members will not be notified until a date is entered into the STRC Notification Date 
Field. This will ensure that all persons that need to be made aware of the event (i.e., study team 
members and STRC members) will be notified; remember to file a copy of your confirmation.  
3. Ensure that you document that the appropriate person(s) on the STRC has been contacted.  
Indicate the name of the STRC clinician that was contacted in the comments field in the SAE 
console of the particular subject. 
4. In addition, it is very important to enter whether or not the protocol should be suspended based 
on the discussion with the STRC clinician.  This is the major function of the email notification. 
This should also be entered in the comments field in the SAE console of the subject. 
5. Follow up/update the clinical member(s) of STRC regarding any new developments or 
information obtained during the course of the SAE investigation and reporting process.  
 
Elements to complete the SAE form in the Subject Console in WISER: 
1. Event Date 
2. Reported Date 
3. Reported by 
 
ADVERSE EVENT 
Grade 1, Grade 2, Grade 3 
 
Grade 4 
Grade 5 
Unexpected 
Expected 
Unexpected 
Expected 
Unexpected 
Expected 
Unrelated 
Not Required 
Not 
Required 
REPORT TO 
STRC 
Not 
Required 
REPORT TO 
STRC 
REPORT TO 
STRC 
Unlikely 
Not Required 
Not 
Required 
REPORT TO 
STRC 
Not 
Required 
REPORT TO 
STRC 
REPORT TO 
STRC 
Possible 
Not Required 
Not 
Required 
REPORT TO 
STRC 
Not 
Required 
REPORT TO 
STRC 
REPORT TO 
STRC 
Probable 
Not Required 
Not 
Required 
REPORT TO 
STRC 
Not 
Required 
REPORT TO 
STRC 
REPORT TO 
STRC 
Definite 
Not Required 
Not 
Required 
REPORT TO 
STRC 
Not 
Required 
REPORT TO 
STRC 
REPORT TO 
STRC 

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4. If Grade 5, enter Death Date 
5. Death occurred: within 30 days 
6. Event Narrative: Brief description (include brief clinical history relevant to this event, including 
therapies believed related to event).  
7. Treating Physician comments 
8. PI comments if available 
9. Protocol Attribution after discussion with STRC clinician 
10. Outcome 
11. Consent form Change Required? Y/N 
12. SAE Classification *This is required in order for the email notification to be sent* 
13. Adverse Event Details – Enter all details for each AE associated with the SAE. 
a. Course start date 
b. Category 
c. AE Detail 
d. Comments 
i. STRC clinician name and comments 
ii. Date of last dose before the event 
iii. Is suspension of the protocol needed? 
e. Grade/Severity 
f. Unexpected Y/N 
g. DLT Y/N 
h. Attributions 
i. 
Action 
j. 
Therapy. 
14. Enter Date Notified STRC -- *This is required for the email notification to be sent* 
 
The Clinical Members of STRC to Notify by Phone or Page: 
Bayard Powell, MD – Director-at-Large, CCCWFU; Section Head, Hematology/Oncology  
Glenn Lesser, MD – Hematology Oncology  
Stefan Grant, MD, JD-Hematology Oncology  
Jimmy Ruiz, MD-Hematology Oncology  
Kathryn Greven, MD – Vice Chair–Radiation Oncology  
Marissa Howard-McNatt, MD – General Surgery  
Mercedes Porosnicu, MD- Hematology Oncology  
 
Definition of Unavailable:  
As a general guideline if the first clinician that is contacted does not respond to the phone call or page 
within 30 minutes, then initiate contact with their backup.  Allow up to 30 minutes for the backup to 
respond to a phone call or page before contacting another member. These times (30 minutes) are a 
general guideline.  You must use your best judgment as a clinical research professional given the time of 
day, severity of the SAE, and other circumstances as to when it is appropriate to contact backup 
clinicians.  If the event occurs near the end of day, then leave messages (voice or email) as appropriate 
and proceed with submitting your STRC notification form.  It is important that you have taken 
reasonable steps and documented that you have initiated some type of contact to one or more of the 
clinical members of STRC. 
STRC CLINICAN RESPONSIBILITY: 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
Page 25 of 55 
It is the responsibility of the STRC clinician to review all reported events, evaluate the events as they are 
reported; and communicate a response to the Investigator, event reporter and the members of STRC. 
The review will include but not be limited to the information reported; there may be times when 
additional information is needed in order for an assessment to be made and further communication 
directly with the investigator may be warranted. STRC reserves the right to agree with the investigator’s 
assessment if STRC does not agree with the investigator. STRC reserves the right to suspend the trial 
pending further investigation.  If there is any immediate danger or harm that could be present for a 
future patient based on the information provided in the STRC report then an immediate suspension of 
enrollment should be considered. 
 
AMENDMENTS TO PREVIOUS REPORTS 
If you are not able to supply all pertinent information with the initial submission, once the additional 
information is available do not submit a new report. Go to the original email that was received by STRC 
and others “reply to all” and entitle your email “Amendment for (list date of event and patient ID)” this 
will avoid duplications of the same event. List the additional information which you are reporting. This 
information needs to be entered into WISER as well. To do this, go to the Subject console and click SAEs 
on the left column.  Click on the appropriate SAE number that needs updating.  Then click update.  This 
will allow you to add additional information. 
 
Acronyms  
STRC-Safety and Toxicity Review Committee 
SAE-Serious Adverse Event 
IRB-Institutional Review Board 
CCCWFU-Comprehensive Cancer Center Wake Forest University 
NCI-National Cancer Institute 
CPDM-Clinical Protocol and Data Management 
WISER –Wake Integrated Solution for Enterprise Research 
 
 
 
 
 
 
 
 

Use of Systems Support Mapping to Guide Patient-Driven Self-Management in  
Rural and Urban Cancer Survivors 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 99118 
 
Protocol version date 6/07/2019 
 
 
 
 
 
 
Page 26 of 55 
 
Appendix E – Adverse Event Log 
WFBCCC Adverse Event (AE) Log 
PI: _________________ 
 
PID: _________________ 
 
MRN: ________________ 
 
 
 
Cycle Start Date: _____________ 
Cycle End Date: _______________ 
 
Cycle #: __________ 
 
 
 
 
Adverse 
Event CTC 
Term 
Value 
(-5 if non-
numeric) 
Grade  
(0-5) 
per 
CTC 
Start 
Date 
Attribution 
1=Related 
2=Probably 
3=Possible 
4=Unlikely 
5=Unrelated 
Treating MD 
Initials/Date 
End 
Date 
Expected 
1=Yes      
0=No 
*Serious 
Adverse 
Event (SAE)   
1=Yes 0=No 
Dose 
Limiting 
Toxicity 
(DLT) 1=Yes 
0=No 
Action 
Taken 
1=None     
2=Tx 
withheld 
3=Tx D/C   
4=Tx 
adjusted 
5=Other 
Reportable?   
1=IRB  
2=STRC  
3=FDA  
4=Sponsor 
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
 
  
  
  
  
  
  
 
  
  
  
  
 
  
  
  
  
  
  
 
  
  
  
  
 
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
*Serious Adverse Event: Hospitalization; Disability; Birth Defect; Life-threatening; Death. 
CTCAE Version 4 - http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
27 
Appendix F – Study Questionnaires 
 
 
 
 
 
 
 
 
Mapping to Guide Self-Management in Cancer Survivors 
 
Baseline Questionnaire 
 
 
 
 
 
 
 
 
 
Study ID: _______ 
Date: _______ 
 
Name of Facilitator: _______________________ 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
28 
Please answer each of the following questions to the best of your ability.  We ask that 
you try not to skip any questions or write in any answers that are not given as choices 
for that particular question. There are no “right” or “wrong” answers for any of the 
questions, so please be honest in answering all questions.  We encourage you not to 
spend too much time on any single question.  Please go with your first instinct in 
answering most of the questions, as many of the questions ask you to state your 
opinion.  Thank you again for your time.  All responses will be kept completely 
confidential. 
 
 
A. The next few questions about your background are important to help describe, 
in general terms, people who are part of this study. 
 
A1.  What is your date of birth?            ___  ___ / ___  ___ / ___  ___  ___ ___ 
 
 
   
 
 
    
 
Month         Day           Year 
 
A2.   What is your current age?    
___ ___     
 
 
 
 
 
 
 
 
 
 
  
  Age 
 
 
A3.  Are you… (check one) 
 Currently married 
 
 
 
 
 
  
 
 Currently living with partner 
  
 
 Separated  
 
 
 
 
 
  
 
 Divorced 
  
 
 Widowed  
 
 
 
 
 
  
 
 Single, never married 
 Prefer not to answer 
 
A4.  What was the highest grade of school that you completed? 
  Less than 8th grade 
 
 
 
 
  8th to 11th grades 
  
 
  High school graduate or equivalent (GED)  
  
 
  Technical or vocational school  
  
 
  Some college  
 
 
 
 
 
  
 
  College graduate  
  
 
  Post-graduate degree   
 Prefer not to answer 
 
A5.  How difficult is it for you (and your family) to pay your monthly bills? 
 Very difficult 
 Somewhat difficult 
 Not very difficult 
 Not at all difficult 
 
A6. How many minutes did it take you to get to travel to the clinic? _______minutes 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
29 
A7. Do you use the internet or email, at least occasionally?  
 No 
 Yes 
 
A8. How confident are you filling out medical forms by yourself? 
 Extremely 
 Quite a bit 
 Somewhat 
 A little bit 
 Not at all 
 
A9. How many times have you received income from AFDC, TANF, Work First, WIC or 
food stamps as an adult? 
 Never 
 Once 
 Twice 
 Three times 
 Four times 
 More than four times 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
30 
B. The next section will ask you some questions about your health behaviors.  
 
Physical activities are activities where you move and increase your heart rate above its resting 
rate, whether you do it for pleasure, work or transportation. The following questions ask about 
the amount and intensity of physical activity you usually do. The intensity of an activity is 
related to the amount of energy you use to do these activities. 
 
 
B1. How physically active are you? (check one answer on each line) 
 
Does this 
accurately 
describe you? 
a) I rarely or never do any physical activities. 
Yes 
 
No 
 
b) I do some light or moderate physical activities, but not every 
week. 
Yes 
 
No 
 
c) I do some light physical activity every week. 
Yes 
 
No 
 
d) I do moderate physical activities every week, but less than 30 
minutes a day or 5 days a week. 
Yes 
 
No 
 
e) I do vigorous physical activities every week, but less than 20 
minutes a day or 3 days a week. 
Yes 
 
No 
 
f) I do 30 minutes or more a day of moderate physical 
activities, 5 or more days a week. 
Yes 
 
No 
 
g) I do 20 minutes or more a day of vigorous physical activities, 
3 or more days a week.  
Yes 
 
No 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
31 
This section will ask you some questions about smoking. For the questions below, please try 
to select a single number. 
B2. Have you smoked at least 100 cigarettes (5 packs=100 cigarettes) in your entire life? 
 Yes 
 No         Go to Question B6. 
 Don’t know / Not sure         Go to Question B6. 
B3.  How many total years have you smoked (or did you smoke) cigarettes? Do not 
     count any time you may have stayed off cigarettes. 
_____ Years     If you smoked less than one year, write “1.” 
B4. On average when you have smoked, about how many cigarettes do you (or did you) 
     smoke a day? 
A pack usually has 20 cigarettes in it. 
_____ Number of cigarettes per day 
 
B5.  How long has it been since you last smoked a cigarette (even one or two puffs)? 
First check which one of the following choices applies to you. Then, if applicable, write a 
number on the line for how many days, weeks, months, or years it has been since your last 
cigarette. 
 I smoked a cigarette today (at least one puff). 
 1-7 days.         Number of days since last cigarette: _____ 
 Less than 1 month.         Number of weeks since last cigarette: _____ 
 Less than 1 year.         Number of months since last cigarette: _____ 
 More than 1 year.         Number of years since last cigarette: _____ 
 Don’t know / Don’t remember. 
 
B6.  Which of the following phrases best characterizes you at this time? (Please mark only one 
response.) 
 
 Normal, no complaints, no symptoms of disease 
 Able to carry on normal activity, minor symptoms of disease 
 Normal activity with effort, some symptoms of disease 
 Care for self, unable to carry on normal activity or to do active work 
 Require occasional assistance but able to care for most of personal needs 
 Require considerable assistance for personal care 
 Disabled, require special care and assistance 
 Severely disabled, require continuous nursing care 
 
B7. How many times have you fallen in the last 6 months?    ____ times 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
32 
B8.  
At any time since you were first diagnosed with cancer, have you used any of 
the following complementary and alternative therapies?   
 
 
No 
Yes 
Have you used them in the 
past year?  
a. Special diets such as mostly vegetarian or low 
fat 
0
 
1
   
0
 No 
1
 Yes 
b. Movement or physical therapies such as yoga, 
tai chi, massage, chiropractic, or 
electromagnetic therapy  
0
 
1
  
0
 No 
1
 Yes 
c. High dose or mega vitamins (DO NOT include 
1-a-day multivitamins), nutritional supplements, 
or herbal remedies 
0
 
1
  
0
 No 
1
 Yes 
d. Homeopathy (small doses of drugs that in a 
healthy person would produce symptoms like 
those of the disease)  
0
 
1
  
0
 No 
1
 Yes 
e. Mind/body therapies such as guided 
imagery/visualization, biofeedback, meditation, 
relaxation techniques, hypnosis/hypnotherapy, 
energy healing, therapeutic touch, or music 
therapy 
0
 
1
  
0
 No 
1
 Yes 
f. Oriental therapies such as acupuncture, 
acupressure, Qigong, or Shiatsu  
0
 
1
  
0
 No 
1
 Yes 
g. Self-help or support groups (either face-to-face 
or on the Internet)   
0
 
1
  
0
 No 
1
 Yes 
h. Psychological therapy or counseling from a 
psychologist, psychiatrist, social worker, or any 
other mental health professional 
0
 
1
  
0
 No 
1
 Yes 
i. 
Faith healing, laying on of hands, or any other 
spiritual or religious group experience 
0
 
1
  
0
 No 
1
 Yes 
j. 
Personal prayer or personal spiritual healing 
0
 
1
  
0
 No 
1
 Yes 
k. Other, please specify: 
_______________________________ 
0
 
1
  
0
 No 
1
 Yes 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
33 
Index of Autonomous Functioning (Authorship/Self-Congruance Subscale): 
Below is a collection of statements about your general experiences. Please indicate how true 
each statement is of your experiences on the whole. Remember that there are no right or wrong 
answers. Please answer according to what really reflects your experience rather than what you 
think your experience should be. 
 
1. My decisions represent my most important values and feelings  
1 
2 
3 
4 
5 
Not at all true 
a bit true 
somewhat true 
mostly true 
completely true 
 
2. I strongly identify with the things that I do  
1 
2 
3 
4 
5 
not at all true 
a bit true 
somewhat true 
mostly true 
completely true 
 
3. My actions are congruent with who I really am 
 
1 
2 
3 
4 
5 
not at all true 
a bit true 
somewhat true 
mostly true 
completely true 
 
4. My whole self stands behind the important decisions I make 
 
1 
2 
3 
4 
5 
not at all true 
a bit true 
somewhat true 
mostly true 
completely true 
 
5. My decisions are steadily informed by things I want or care about 
1 
2 
3 
4 
5 
not at all true 
a bit true 
somewhat true 
mostly true 
completely true 
 
 
 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
34 
The Self Efficacy for Managing Chronic Disease Scale (SEMCD):  
For each of the following questions, please circle the number that corresponds with your confidence that 
you can do the tasks regularly at the present time 
 
How confident are you that you can... 
1. Keep the fatigue caused by your 
________________________________ 
 
disease from interfering with the  
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
things you want to do? 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 confident 
 
2. Keep the physical discomfort or 
________________________________ 
 
pain of your disease from inter- 
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
fering with the things you want  
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
to do? 
 
3. Keep the emotional distress caused 
________________________________ 
 
by your disease from interfering  
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
with the things you want to do? 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
4. Keep any other symptoms or health 
________________________________ 
 
problems you have from interfering   
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
with the things you want to do? 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
5. Do the different tasks and activities 
________________________________ 
 
needed to manage your health    
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
condition so as to reduce your 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
need to see a doctor? 
 
6. Do things other than just taking 
________________________________ 
 
medication to reduce how much    
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
your illness affects your 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
everyday life? 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
35 
Self-Efficacy for Managing Symptoms – Short Form 4a 
 
Please respond to each question or statement by marking one box per row.  
 
 
 
 
 
 
 
  
  
CURRENT level of confidence… 
I am 
not at all 
confident 
I am 
a little 
confident 
I am 
somewhat 
confident 
I am 
quite 
confident 
I am 
very 
confident 
SEMSX010 I can manage my symptoms during my 
daily activities ............................................ 

1 

2 

3 

4 

5 
SEMSX014 
I can keep my symptoms from interfering 
with relationships with friends and 
family ......................................................... 

1 

2 

3 

4 

5 
SEMSX009 I can manage my symptoms in a public 
place ........................................................... 

1 

2 

3 

4 

5 
 
SEMSX011 I can work with my doctor to manage my 
symptoms ................................................... 

1 

2 

3 

4 

5 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
36 
Perceived Stress Scale 
Instructions: The questions in this scale ask you about your feelings and thoughts during the past 7 
days.  In each case, please indicate with a check how often you felt or thought a certain way.   
1.  In the past 7 days, how often have you felt that you were unable to control the important things in your 
life? 
 ___0=never 
 ___1=almost never 
 ___2=sometimes 
 ___3=fairly often 
 ___4=very often  
 
2.  In the past 7 days, how often have you felt confident about your ability to handle your personal 
problems? 
 
 ___0=never 
 ___1=almost never 
 ___2=sometimes 
 ___3=fairly often 
 ___4=very often 
3.  In the past 7 days, how often have you felt that things were going your way? 
 ___0=never 
 ___1=almost never 
 ___2=sometimes 
 ___3=fairly often 
 ___4=very often 
4.  In the past 7 days, how often have you felt difficulties were piling up so high that you could not 
overcome them? 
 ___0=never 
 ___1=almost never 
 ___2=sometimes 
 ___3=fairly often 
 ___4=very often 
 
 
 
 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
37 
PROMIS-29: 
 
Please respond to each question or statement by marking one box per row. 
 
 
 
Physical Function 
Without 
any 
difficulty 
With a 
little 
difficulty 
With 
some 
difficulty 
With 
much 
difficulty 
Unable 
to do 
1 
Are you able to do chores such as 
vacuuming or yard work? .......................... 

5 

4 

3 

2 

1 
2 
Are you able to go up and down stairs at a 
normal pace? .............................................. 

5 

4 

3 

2 

1 
3 
Are you able to go for a walk of at least 15 
minutes? ..................................................... 

5 

4 

3 

2 

1 
4 
Are you able to run errands and shop? ...... 

5 

4 

3 

2 

1 
 
Anxiety  
In the past 7 days… 
Never 
Rarely 
Sometimes 
Often 
Always 
5 
I felt fearful 
.................................................. 

1 

2 

3 

4 

5 
6 
I found it hard to focus on anything other 
than my anxiety ........................................... 

1 

2 

3 

4 

5 
7 
My worries overwhelmed me 
...................... 

1 

2 

3 

4 

5 
8 
I felt uneasy ................................................. 

1 

2 

3 

4 

5 
 
Depression In the past 7 days... 
Never 
Rarely 
Sometimes 
Often 
Always 
9 
I felt worthless ........................................... 

1 

2 

3 

4 

5 
10 
I felt helpless .............................................. 

1 

2 

3 

4 

5 
11 
I felt depressed ........................................... 

1 

2 

3 

4 

5 
12 
I felt hopeless ............................................. 

1 

2 

3 

4 

5 
 
Fatigue  
During the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
13 
I feel fatigued ............................................. 

1 

2 

3 

4 

5 
14 
I have trouble starting things because I am 
tired ...................................................... 

1 

2 

3 

4 

5 
 
Fatigue  
In the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
15 
How run-down did you feel on average? ... 

1 

2 

3 

4 

5 
16 
How fatigued were you on average? .......... 

1 

2 

3 

4 

5 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
38 
 
 
 
 
 
Sleep Disturbance  
In the past 7 days… 
Very poor 
Poor 
Fair 
Good 
Very 
good 
17 
My sleep quality was .................................. 

5 

4 

3 

2 

1 
18 
My sleep was refreshing. ............................ 

5 

4 

3 

2 

1 
19 
I had a problem with my sleep .................. 

1 

2 

3 

4 

5 
20 
I had difficulty falling asleep .................... 

1 

2 

3 

4 

5 
 
Ability to Participate in Social Roles and 
Activities 
In the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
21 
I have trouble doing all of my regular 
leisure activities with others ....................  
 

5 

4 

3 

2 

1 
22 
I have trouble doing all of the family 
activities that I want to do .......................  
 

5 

4 

3 

2 

1 
23 
I have trouble doing all of my usual work 
(include work at home) ...........................  
 

5 

4 

3 

2 

1 
24 
I have trouble doing all of the activities with 
friends that I want to do ................  
 

5

4

3

2

1
 
Pain Interference  
In the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
25 
How much did pain interfere with your day 
to day activities? .................................. 

1 

2 

3 

4 

5 
26 
How much did pain interfere with work 
around the home? ....................................... 

1 

2 

3 

4 

5 
27 
How much did pain interfere with your 
ability to participate in social activities? . 

1 

2 

3 

4 

5 
28 
How much did pain interfere with your 
household chores? ..................................... 

1 

2 

3 

4 

5 
 
Pain Intensity  
In the past 7 days… 
29 
How would you rate your pain 
on average? 
...................................... 

0 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 
No 
pain 
 
 
 
 
 
 
 
 
Worst 
imaginable 
pain 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
39 
Comprehensive Score for Financial Toxicity (COST): 
 
 Below is a list of statements that other people with your illness have said are important. Please 
circle or mark one number per line to indicate your response as it applies to the past 7 
days. 
 
 
 
 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
1 
I know that I have enough money in savings, 
retirement, or assets to cover the costs of my 
treatment. 
 
0 
 
1 
 
2 
 
3 
 
4 
2 
My out-of-pocket medical expenses are more 
than I thought they would be. 
 
0 
 
1 
 
2 
 
3 
 
4 
3 
I worry about the financial problems I will 
have in the future as a result of my illness or 
treatment. 
 
0 
 
1 
 
2 
 
3 
 
4 
4 
I feel I have no choice about the amount of 
money I spend on care. 
 
0 
 
1 
 
2 
 
3 
 
4 
5 
I am frustrated that I cannot work or 
contribute as much as I usually do. 
 
0 
 
1 
 
2 
 
3 
 
4 
6 
I am satisfied with my current financial 
situation. 
 
0 
 
1 
 
2 
 
3 
 
4 
7 
I am able to meet my monthly expenses. 
 
0 
 
1 
 
2 
 
3 
 
4 
8 
I feel financially stressed. 
 
0 
 
1 
 
2 
 
3 
 
4 
9 
I am concerned about keeping my job and 
income, including work at home. 
 
0 
 
1 
 
2 
 
3 
 
4 
10 
My cancer or treatment has reduced my 
satisfaction with my present financial situation. 
 
0 
 
1 
 
2 
 
3 
 
4 
11 I feel in control of my financial situation. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
40 
 
 
 
 
 
 
 
 
 
Mapping to Guide Self-Management in Cancer Survivors 
 
Follow-Up Questionnaire 
 
 
 
 
 
 
 
 
 
Study ID: _______ 
Date: _______ 
 
Name of Facilitator: _______________________ 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
41 
 
Acceptability - Future Study Planning 
 
1. How important is it for people to have support in determining their own health-
related goals following cancer treatment? 
 
1 
2 
3 
4 
5 
6 
Not at all 
A little bit 
Somewhat Moderately 
Quite a 
bit 
Very much 
 
2. How interested would you be in meeting with someone to follow-up up with you 
on the goals you chose during the study mapping exercise? 
1 
2 
3 
4 
5 
6 
Not at all 
A little bit 
Somewhat Moderately 
Quite a 
bit 
Very much 
 
3. What person would you like to meet with to discuss those goals? 
 
a. A nurse  
b. Other healthcare provider 
c. A mental health provider 
d. A cancer survivor 
e. Any of the above people 
f. Other (please specify): _____________ 
 
4. How often do you think it would be helpful to meet with someone to discuss 
your goals? 
 
a. Weekly 
b. Twice per month 
c. Monthly  
d. I do not think it would be helpful 
e. Other (please specify): ___________ 
 
5. How would you like to meet with someone to discuss your goals? 
 
a. In person at the Cancer Center 
b. In person at my primary healthcare location 
c. On the telephone 
d. Over videoconferencing 
e. I would not like to meet with someone 
f. Other (please specify): ___________ 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
42 
Acceptability - Satisfaction with the Mapping Exercise 
 
Instructions: Please circle the number below that best describes your feelings 
about each statement. 
 
 
 
Acceptability - Overall Satisfaction 
 
Instructions: Please rate the services you received from our facility in general. Circle 
the number that best describes your experience.   
 
Very Poor 
Poor 
Fair 
Good 
Very Good 
1. Degree to which healthcare providers addressed your 
emotional needs 
1 
2 
3 
4 
5 
2. Likelihood of your recommending this medical center to 
others 
1 
2 
3 
4 
5 
3. Overall rating of care given at the medical center 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
Not at All 
A Little Bit 
Somewhat 
Quite a Bit 
Very Much 
   I liked the study mapping exercise. 
0 
1 
2 
3 
4 
The study mapping exercise was helpful to me. 
0 
1 
2 
3 
4 
   I plan to continue to use what I learned. 
0 
1 
2 
3 
4 
   The interventionist who led the mapping was competent. 
0 
1 
2 
3 
4 
   The interventionist who led the mapping was sensitive. 
0 
1 
2 
3 
4 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
43 
HEAL - Patient-Provider Connection - Short Form: 
 
Please respond to each item by marking one box per row. 
 
 
 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
I am satisfied with my healthcare 
provider. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
I trust my healthcare provider. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
My healthcare provider pays 
attention to my individual needs. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
My healthcare provider gives me 
support and encouragement. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
My healthcare provider respects me. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
I feel my healthcare provider 
understands me. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
Never 
Rarely 
Sometimes 
Often 
Almost 
Always 
My healthcare provider gives me 
enough information. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
Think of the person who worked with you to create a map of your experience with cancer during this 
study as the “healthcare provider”… 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
44 
The next section will ask you some questions about your health behaviors.  
 
Physical activities are activities where you move and increase your heart rate above its resting 
rate, whether you do it for pleasure, work or transportation. The following questions ask about 
the amount and intensity of physical activity you usually do. The intensity of an activity is 
related to the amount of energy you use to do these activities. 
 
 
1. How physically active are you? (check one answer on each line) 
 
Does this 
accurately 
describe you? 
a) I rarely or never do any physical activities. 
Yes 
 
No 
 
b) I do some light or moderate physical activities, but not every 
week. 
Yes 
 
No 
 
c) I do some light physical activity every week. 
Yes 
 
No 
 
d) I do moderate physical activities every week, but less than 30 
minutes a day or 5 days a week. 
Yes 
 
No 
 
e) I do vigorous physical activities every week, but less than 20 
minutes a day or 3 days a week. 
Yes 
 
No 
 
f) I do 30 minutes or more a day of moderate physical 
activities, 5 or more days a week. 
Yes 
 
No 
 
g) I do 20 minutes or more a day of vigorous physical activities, 
3 or more days a week.  
Yes 
 
No 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
45 
This section will ask you some questions about smoking. For the questions below, please try 
to select a single number. 
 
2. Have you smoked at least 100 cigarettes (5 packs=100 cigarettes) in your entire life? 
 Yes 
 No         Go to Question B6. 
 Don’t know / Not sure         Go to Question B6. 
3.  How many total years have you smoked (or did you smoke) cigarettes? Do not 
     count any time you may have stayed off cigarettes. 
_____ Years     If you smoked less than one year, write “1.” 
4. On average when you have smoked, about how many cigarettes do you (or did you) 
     smoke a day? 
A pack usually has 20 cigarettes in it. 
_____ Number of cigarettes per day 
 
5.  How long has it been since you last smoked a cigarette (even one or two puffs)? 
First check which one of the following choices applies to you. Then, if applicable, write a 
number on the line for how many days, weeks, months, or years it has been since your last 
cigarette. 
 I smoked a cigarette today (at least one puff). 
 1-7 days.         Number of days since last cigarette: _____ 
 Less than 1 month.         Number of weeks since last cigarette: _____ 
 Less than 1 year.         Number of months since last cigarette: _____ 
 More than 1 year.         Number of years since last cigarette: _____ 
 Don’t know / Don’t remember. 
 
6.  Which of the following phrases best characterizes you at this time? (Please mark only one 
response.) 
 Normal, no complaints, no symptoms of disease 
 Able to carry on normal activity, minor symptoms of disease 
 Normal activity with effort, some symptoms of disease 
 Care for self, unable to carry on normal activity or to do active work 
 Require occasional assistance but able to care for most of personal needs 
 Require considerable assistance for personal care 
 Disabled, require special care and assistance 
 Severely disabled, require continuous nursing care 
7. How many times have you fallen in the last 6 months?    ____ times 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
46 
8. Have you used any of the following complementary and alternative therapies in the 
past 2 weeks?   
 
 
No 
Yes 
a. Special diets such as mostly vegetarian or low fat 
0
 
1
  
 
b. Movement or physical therapies such as yoga, tai chi, 
massage, chiropractic, or electromagnetic therapy  
0
 
1
  
c. High dose or mega vitamins (DO NOT include 1-a-day 
multivitamins), nutritional supplements, or herbal 
remedies 
0
 
1
  
d. Homeopathy (small doses of drugs that in a healthy 
person would produce symptoms like those of the 
disease)  
0
 
1
  
e. Mind/body therapies such as guided 
imagery/visualization, biofeedback, meditation, 
relaxation techniques, hypnosis/hypnotherapy, energy 
healing, therapeutic touch, or music therapy 
0
 
1
  
f. Oriental therapies such as acupuncture, acupressure, 
Qigong, or Shiatsu  
0
 
1
  
g. Self-help or support groups (either face-to-face or on 
the Internet)   
0
 
1
  
h. Psychological therapy or counseling from a 
psychologist, psychiatrist, social worker, or any other 
mental health professional 
0
 
1
  
i. 
Faith healing, laying on of hands, or any other spiritual 
or religious group experience 
0
 
1
  
j. 
Personal prayer or personal spiritual healing 
0
 
1
  
k. Other, please specify: 
_______________________________ 
0
 
1
  
 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
47 
Index of Autonomous Functioning: 
Below is a collection of statements about your general experiences. Please indicate how true 
each statement is of your experiences on the whole. Remember that there are no right or wrong 
answers. Please answer according to what really reflects your experience rather than what you 
think your experience should be. 
 
1. My decisions represent my most important values and feelings  
1  
 
2 
 
3 
 
4 
 
5 
not at all true    a bit true 
somewhat true   mostly true  completely true 
 
2. I strongly identify with the things that I do  
1  
 
2 
 
3 
 
4 
 
5 
not at all true    a bit true 
somewhat true   mostly true  completely true 
 
3. My actions are congruent with who I really am 
 
1  
 
2 
 
3 
 
4 
 
5 
not at all true   a bit true 
somewhat true   mostly true  completely true 
 
4. My whole self stands behind the important decisions I make 
 
1  
 
2 
 
3 
 
4 
 
5 
not at all true     a bit true 
somewhat true     mostly true  completely true 
 
5. My decisions are steadily informed by things I want or care about 
1  
 
2 
 
3 
 
4 
 
5 
not at all true    a bit true 
somewhat true   mostly true  completely true 
 
 
 
 
 
 
 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
48 
The Self Efficacy for Managing Chronic Disease Scale (SEMCD):  
For each of the following questions, please circle the number that corresponds with your confidence that 
you can do the tasks regularly at the present time 
 
How confident are you that you can... 
1. Keep the fatigue caused by your 
________________________________ 
 
disease from interfering with the  
not at all | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
things you want to do? 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 confident 
 
2. Keep the physical discomfort or 
________________________________ 
 
pain of your disease from inter- 
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
fering with the things you want  
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
to do? 
 
3. Keep the emotional distress caused 
________________________________ 
 
by your disease from interfering  
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
with the things you want to do? 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
4. Keep any other symptoms or health 
________________________________ 
 
problems you have from interfering   
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
with the things you want to do? 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
5. Do the different tasks and activities 
________________________________ 
 
needed to manage your health    
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
condition so as to reduce your 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
need to see a doctor? 
 
6. Do things other than just taking 
________________________________ 
 
medication to reduce how much    
not at all 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
totally 
 
your illness affects your 
confident 
1 
2 
3 
4 
5 
6 
7 
8 
9 10 
confident 
 
everyday life? 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
49 
Self-Efficacy for Managing Symptoms – Short Form 4a 
 
Please respond to each question or statement by marking one box per row.  
 
 
 
 
  
  
CURRENT level of confidence… 
I am 
not at all 
confident 
I am 
a little 
confident 
I am 
somewhat 
confident 
I am 
quite 
confident 
I am 
very 
confident 
SEMSX010 I can manage my symptoms during my 
daily activities ............................................ 

1 

2 

3 

4 

5 
SEMSX014 
I can keep my symptoms from interfering 
with relationships with friends and 
family ......................................................... 

1 

2 

3 

4 

5 
SEMSX009 I can manage my symptoms in a public 
place ........................................................... 

1 

2 

3 

4 

5 
 
SEMSX011 I can work with my doctor to manage my 
symptoms ................................................... 

1 

2 

3 

4 

5 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
50 
Perceived Stress Scale 
Instructions: The questions in this scale ask you about your feelings and thoughts during the past 7 
days.  In each case, please indicate with a check how often you felt or thought a certain way.   
  
1.  In the past 7 days, how often have you felt that you were unable to control the important things in your 
life? 
 
___0=never 
___1=almost never  
___2=sometimes  
___3=fairly often  
___4=very often 
 
2.  In the past 7 days, how often have you felt confident about your ability to handle your personal 
problems? 
 
 ___0=never  
 ___1=almost never 
 ___2=sometimes  
 ___3=fairly often 
 ___4=very often 
 
4. In the past 7 days, how often have you felt that things were going your way? 
 
 ___0=never 
 ___1=almost never 
 ___2=sometimes 
 ___3=fairly often 
 ___4=very often 
 
4.  In the past 7 days, how often have you felt difficulties were piling up so high that you could not 
overcome them? 
 
 ___0=never 
 ___1=almost never 
 ___2=sometimes 
 ___3=fairly often 
 ___4=very often 
 
 
 
 
 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
51 
PROMIS-29: 
 
Please respond to each question or statement by marking one box per row. 
 
Physical Function 
Without 
any 
difficulty 
With a 
little 
difficulty 
With 
some 
difficulty 
With 
much 
difficulty 
Unable 
to do 
1 
Are you able to do chores such as 
vacuuming or yard work? .......................... 

5 

4 

3 

2 

1 
2 
Are you able to go up and down stairs at a 
normal pace? .............................................. 

5 

4 

3 

2 

1 
3 
Are you able to go for a walk of at least 15 
minutes? ..................................................... 

5 

4 

3 

2 

1 
4 
Are you able to run errands and shop? ...... 

5 

4 

3 

2 

1 
 
Anxiety  
In the past 7 days… 
Never 
Rarely 
Sometimes 
Often 
Always 
5 
I felt fearful 
.................................................. 

1 

2 

3 

4 

5 
6 
I found it hard to focus on anything other 
than my anxiety ........................................... 

1 

2 

3 

4 

5 
7 
My worries overwhelmed me 
...................... 

1 

2 

3 

4 

5 
8 
I felt uneasy ................................................. 

1 

2 

3 

4 

5 
 
Depression In the past 7 days... 
Never 
Rarely 
Sometimes 
Often 
Always 
9 
I felt worthless ........................................... 

1 

2 

3 

4 

5 
10 
I felt helpless .............................................. 

1 

2 

3 

4 

5 
11 
I felt depressed ........................................... 

1 

2 

3 

4 

5 
12 
I felt hopeless ............................................. 

1 

2 

3 

4 

5 
 
 
 
Fatigue  
During the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
13 
I feel fatigued ............................................. 

1 

2 

3 

4 

5 
14 
I have trouble starting things because I am 
tired ...................................................... 

1 

2 

3 

4 

5 
 
Fatigue  
In the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
15 
How run-down did you feel on average? ... 

1 

2 

3 

4 

5 
16 
How fatigued were you on average? .......... 

1 

2 

3 

4 

5 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
52 
 
 
Sleep Disturbance  
In the past 7 days… 
Very poor 
Poor 
Fair 
Good 
Very 
good 
17 
My sleep quality was .................................. 

5 

4 

3 

2 

1 
18 
My sleep was refreshing. ............................ 

5 

4 

3 

2 

1 
19 
I had a problem with my sleep .................. 

1 

2 

3 

4 

5 
20 
I had difficulty falling asleep .................... 

1 

2 

3 

4 

5 
 
Ability to Participate in Social Roles and 
Activities 
In the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
21 
I have trouble doing all of my regular 
leisure activities with others ....................  
 

5 

4 

3 

2 

1 
22 
I have trouble doing all of the family 
activities that I want to do .......................  
 

5 

4 

3 

2 

1 
23 
I have trouble doing all of my usual work 
(include work at home) ........................  
 

5 

4 

3 

2 

1 
24 
I have trouble doing all of the activities with 
friends that I want to do ..................  
 

5

4

3

2

1
 
Pain Interference  
In the past 7 days… 
Not at all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
25 
How much did pain interfere with your day 
to day activities? .................................. 

1 

2 

3 

4 

5 
26 
How much did pain interfere with work 
around the home? ....................................... 

1 

2 

3 

4 

5 
27 
How much did pain interfere with your 
ability to participate in social activities? . 

1 

2 

3 

4 

5 
28 
How much did pain interfere with your 
household chores? ..................................... 

1 

2 

3 

4 

5 
 
Pain Intensity  
In the past 7 days… 
29 
How would you rate your pain 
on average? 
...................................... 

0 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 
No 
pain 
 
 
 
 
 
 
 
 
Worst 
imaginable 
pain 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
53 
Appendix G – Chart Review Data Collection Form  
 
Mapping to Guide Self-Management in Cancer Survivors 
 
Participant ID:_________  
 
 
BASELINE CLINICAL DATA 
 
1. Weight: ___ ___ ___lbs. 
2. Height: ___ ___in. 
3. BMI: ___ ___ 
4. Date for BMI (mm/dd/yy): __ __/__ __/__ __ 
 
Primary Diagnosis  
 
 
 
 
5. Date of initial colorectal cancer pathological diagnosis (mm/dd/yy): __ __/__ __/__ 
__ 
 
6. Primary Tumor Site (select one):    
 Colon 
 Rectum 
 Other: ___________________________ 
 Unknown Primary _________________ 
       
7. AJCC overall staging at diagnosis:   
         
T ___  N____ M ____     
 
7a. Summary Stage:  
  0    
  IIIA    
  I     
  IIIB 
  IIA 
  IIIC 
  IIB 
  IVA   
  IIC 
 IVB 
 
Date Abstraction Completed:  ____ ____/____ ____/____ ____    
 
Abstracter’s Initials _____________ 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
54 
8. Is this recurrent disease?     
  No   
  Yes 
          If yes,  
8a. Date of Recurrence (mm/dd/yy): __ __/__ __/__ __      
 
Prior Treatment Details: 
9. History of any cancer-related surgical procedure(s):  
  No 
  Yes  
9a. Surgery Date (mm/dd/yy): __ __/__ __/__ __ 
9b. Surgery Date (mm/dd/yy): __ __/__ __/__ __ 
 
10. History of Radiation Therapy 
  No    
  Yes: 
10a. Was radiation therapy given for colorectal cancer? 
  
  No    
  Yes    
10b. Date most recent treatment was completed (mm/dd/yy): __ __/__ 
__/__ __ 
 
11.  History of Chemotherapy?  
  No    
  Yes           
11a. Was chemotherapy given for colorectal cancer? 
  
  No    
  Yes   
 
 
11b. Date most recent treatment was completed (mm/dd/yy): __ __/__ 
__/__ __ 
    
12. Other Cancer Treatments?  
  No  
  Yes (describe): ____________________________________________________ 
 
 
12b. Date most recent treatment was completed (mm/dd/yy): __ __/__ 
__/__ __ 
 
 
 
 

Study ID: _______ 
 
Date: _________ 
Version 0.4 
 
 
 
 
 
 
 
 
 
 
05/14/18 
 
55 
13.  Comorbidities: 
 Myocardial infarction 
 Congestive heart failure 
 Peripheral Vascular Disease  
 Cerebrovascular Disease (CVD) 
 Chronic obstructive pulmonary disease 
 Dementia 
 Paralysis (Hemiplegia or Paraplegia) 
 Diabetes or diabetes with complications 
 Renal disease 
 Any liver disease 
 Peptic ulcer disease 
 Rheumatologic disease 
 AIDS 
 Other cancer (describe): ___________________