Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
Phase: NA
Conditions: Lynch Syndrome
Sponsor: UNC Lineberger Comprehensive Cancer Center

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20-3115: Overcoming barriers to the uptake of cascade screening for Lynch 
Syndrome 
 
 
Principal Investigator 
Megan Roberts, Ph.D. 
2215 Kerr Hall, Faculty Lab, CB# 7573, Chapel Hill, NC, 27599 
(919) 843-4071 
megan.roberts@unc.edu 
Principal Co-Investigator 
Rachel Pearlman, MS, LGC 
Co-Investigator(s) 
Jonathan Berg, MD, Ph.D. 
Jennifer Leeman, DRPH, MPH, MDIV 
Dan Reuland, MD, MPH 
Hanna Sanoff, MD, MPH 
Emily Olsson, CCRP 
Lauren Passero 
Angelo Navas 
 
Biostatistician 
Megan Roberts, Ph.D. 
 
 
Sponsor: NIH National Center for Advancing Translational Sciences 
 
Funding Source: National Institutes of Health NCATS 
Version Date: 06/06/2025 

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Master Protocol – Summary of changes from previous version 
 
Version 
V. Date 
Revision summary 
PRC status 
IRB status 
1.0 
03/01/2021 n/a – Initial submission 
accrual tracking 
only, PRC not 
required. 
Approved on 
06/14/2021 
2.0 
6/22/2021 
The patient recruitment process has 
been updated. Patient records will be 
accessed by genetic counselors to 
identify potential participants to be 
contacted about the study 
opportunity. A partial waiver of 
HIPAA authorization is being 
requested, and the data sources, 
recruitment questions, and study 
protocol have been updated to 
reflect the revised recruitment plan. 
The verbal consent scripts have been 
revised to emphasize that the 
enrollment call is related to the study 
opportunity previously shared with 
the participant. The information 
sheets have been updated to identify 
OSU as a collaborator. 
accrual tracking 
only, PRC not 
required. 
Approved on 
9/1/2021 
3.0 
11/3/2021 
Modifications to the recruitment and 
informed consent process for 
participants, informed consent will 
be gathered from patients and 
genetic counselors who wish to 
provide feedback on using the 
workbook before conducting a follow 
up interview and survey. Patients 
and genetic counselors will still be 
contacted by email to introduce the 
study opportunity. However, the 
email will only discuss providing 
feedback about the workbook as part 
of the simplified consent process that 
does not disrupt genetic counselor 
workflow. 
accrual tracking 
only, PRC not 
required. 
Approved 
on 
1/13/2022 
4.0 
2/1/2022 
Ohio State University was 
added as a second site and 
study was updated to a 
multi-site study. 
accrual tracking 
only, PRC not 
required. 
Approved on 
2/28/2022 

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5.0 
3/28/2023 
The recruitment strategy was 
expanded. In addition to patients 
with Lynch Syndrome being recruited 
through genetic counselors at Ohio 
State University and UNC Chapel Hill, 
newly diagnosed patients will also be 
recruited through the Lynch 
Syndrome International (LSI) 
Facebook community due to 
personnel changes and recruitment 
delays at OSU. An advertisement will 
be posted on the LSI Facebook page 
to share the study opportunity, and 
patients with Lynch Syndrome who 
see the advertisement will be able to 
email to join the study. Verbal 
consent will be collected for patients 
recruited through LSI using an 
updated verbal consent script that 
accounts for this modification. 
accrual tracking 
only, PRC not 
required. 
Approved on 
5/12/2023 
6.0 
6/20/2023 
The eligibility criteria were changed. 
Instead of calling patients to assess 
initial eligibility, an online survey link 
(using REDCap) will be sent in 
response to their interest email, 
which includes eligibility criteria (see 
attached Eligibility Screener). 
Additionally, sociodemographic items 
will be included in this survey to 
meet enrollment goals and ensure 
representative enrollment by race, 
ethnicity, and gender. Once eligibility 
has been determined, follow-up will 
be conducted by the research 
assistant via email to schedule a call 
with the eligible participant to 
complete informed consent or to 
inform them that they are not 
eligible to participate in the study. 
accrual tracking 
only, PRC not 
required. 
Approved on 
6/28/2023 

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7.0 
5/29/2025 
Several updates were made to the 
protocol to reflect changes in the 
recruitment approach: 
(1) the analysis software was 
changed from Atlas.ti to NVivo 
(2) the language was revised to refer 
only to patients, removing 
references to genetic counselors 
given that recruitment 
approaches changed  
(3) Section 7.2 was updated to list 
only the UNC IRB as the IRB of 
record. 
 
These changes were necessary due 
to earlier modifications in the 
recruitment strategy. No patients 
were recruited from Ohio State 
University due to personnel changes 
and recruitment delays. As a result, 
recruitment through the Lynch 
Syndrome International (LSI) 
Facebook community was prioritized 
over recruitment through genetic 
counselors. 
 
accrual tracking 
only, PRC not 
required. 
6/06/2025 
 
Protocol Amendment (v7. 06062025) 
Summary of Changes: 
• 
Recruitment procedures were updated to include Lynch Syndrome International's social 
media page as a recruitment site. 
• 
Participants were recruited through Lynch Syndrome International. 

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• 
Recruitment through Lynch Syndrome International was prioritize over genetic 
counselors’ recruitment. 
• 
No patients were recruited from OSU due to personnel changes and recruitment delays. 
Consents: 
• 
Updated verbal consent script for patients recruited through LSI. 

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LCCC 20-3115: Overcoming barriers to the uptake of cascade screening for Lynch 
Syndrome 
 
Principal Investigator 
Dr. Megan Roberts, Ph.D. 
2215 Kerr Hall, Faculty Lab, CB# 7573, Chapel Hill, NC, 27599 
(919) 843-4071 
megan.roberts@unc.edu 
 
 
Signature Page 
The signature below constitutes the approval of this protocol and the attachments and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable U.S. federal regulations 
and ICH guidelines. 
 
Principal Investigator (PI) Name: Megan Roberts 
 
 
PI Signature:    
  
 

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1. BACKGROUND AND RATIONALE 
 
1.1. Study Synopsis 
We will trial an educational workbook on family cascade screening for 
individuals diagnosed with Lynch Syndrome, a genetic predisposition for 
certain types of cancer. Up to 5 genetic counselors at Ohio State University 
(OSU) and the University of North Carolina at Chapel Hill (UNC Chapel Hill) 
as well as 15 patients at OSU, University of North Carolina at Chapel Hill 
(UNC Chapel Hill), and Lynch Syndrome International (LSI) will pilot test 
the workbook and we will conduct surveys and qualitative interviews to 
understand the feasibility, acceptability, practicality, and economic impact of 
the workbook. The research team developed the workbook in a previous 
project using implementation science strategies to identify and develop an 
intervention for barrier and facilitators to family screening for Lynch 
Syndrome. 
 
1.2. Background 
An estimated 1 million people in the US have Lynch Syndrome (LS), a 
genetic disorder that increases lifetime risk for several cancers including up to 
82% for colorectal cancer (CRC) and 60% for endometrial cancers (compared 
to 4% and 3% in the general population, respectively). Universal testing of all 
CRC and endometrial cancer patients for LS is an effective approach for 
identifying affected individuals and reducing their risk of subsequent cancers 
through enhanced screening and primary prevention strategies. The cost 
effectiveness of universal testing for LS hinges on cascade screening, the 
systematic identification and testing of family members of affected 
individuals. Unfortunately, many family members of patients with LS do not 
receive cascade screening. In previous research, we identified barriers to 
cascade screening including low knowledge, skills, and self-efficacy and 
perceived barriers such as family dynamics, cost, and fear of discrimination. 
We also identified facilitators including expectations of positive outcomes 
from communicating with family members and options for free family 
member testing. We used intervention mapping to identify an intervention that 
targets actionable barriers and facilitators to improve cascade screening 
uptake for LS. 
1.3. Purpose and Rationale 
The objective of this project is to test the feasibility and implementation of our 
intervention, an educational workbook on the importance of cascade screening 
for Lynch Syndrome families. Fifteen patients diagnosed with Lynch 
Syndrome will test the workbook. We will assess the success of the workbook 
as a tool to improve cascade screening through post-intervention surveys and 
a qualitative interview. This feasibility study will provide foundational 
knowledge on the usefulness and acceptability of the workbook to inform an 
R01 to test if the intervention can improve cascade screening uptake when 

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used in the clinical environment. 
 
2. STUDY OBJECTIVES AND ENDPOINTS 
 
2.1. Primary Objective 
The primary research question is: Is Let’s Talk, an educational workbook on 
cascade screening for individuals diagnosed with Lynch Syndrome, a feasible 
intervention for health professionals to improve family testing for Lynch 
Syndrome? 
 
2.2. Secondary Objectives 
There are no secondary objectives in this study. 
3. PATIENT ELIGIBILITY 
3.1. Inclusion Criteria 
3.1.1. 
Participants must meet all of the following inclusion 
criteria to participate in the study. 
3.1.2. 
Patients must have been diagnosed with Lynch Syndrome 
within the last 365 days. 
3.1.3. 
Patients must be age 18 or older. 
3.1.4. 
Patients must be receiving care from genetic counselors at 
UNC Health System OR OSU OR be a part of the Lynch Syndrome 
International advocacy group Facebook page. 
3.1.5. 
Patients must be able to speak and read in English. 
3.1.6. 
Patients must review informed consent documents and 
provide verbal consent to participate in the follow up interview and 
survey. 
 
3.2. Exclusion Criteria 
3.2.1. 
There are no exclusion criteria for study participants. 
 
4. STUDY PLAN 
4.1. Study Design 
This is a nonrandomized, multi-center, interventional feasibility study on the 
use of an educational workbook to improve cascade screening among 
individuals diagnosed with Lynch Syndrome. The study is a single arm, 
interventional trial of 15 patients diagnosed with Lynch Syndrome who are (1) 
patients of genetic counselors at Ohio State University Comprehensive Cancer 
Center or UNC Health System or (2) are member of the LSI Facebook page 
and up to 5 genetic counselors at Ohio State University Comprehensive 
Cancer Center or UNC Health System. The primary purpose of this study is to 
evaluate the feasibility of an educational workbook for Lynch Syndrome 
patients to improve family genetic testing. We anticipate study enrollment will 
take approximately 24 months, cumulative patient active participation will last 
approximately 10 months, and genetic counselor active participation will last 

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approximately 24 months. Individual patient participation duration will be 
approximately 1 month. The feasibility of the intervention workbook will be 
assessed through template analysis2 of qualitative interviews guided by CFIR1 
and quantitative survey design by the research team with scales to assess the 
costs of workbook use, knowledge, perceived knowledge, acceptability3, and 
self-efficacy4. 
 
4.2. Study Recruitment and Activities 
The recruitment goal for genetic counselors is up to 5 genetic counselors. The 
recruitment goal for patients with Lynch Syndrome is 15 total patients 
between OSU, UNC, and LSI. There is no minimum or maximum number of 
patients that can be enrolled at each site up to the goal of 15 patients total. 
 
At OSU and UNC, the co-PI or another member of the research team will 
contact genetic counselors who work with Lynch Syndrome patients via email 
and notify them of the study opportunity and provide an information sheet. 
Interested genetic counselors will use the workbook with their Lynch 
Syndrome patients as a support tool for their standard cascade screening. The 
genetic counselors will provide the workbook to patients likely to test positive 
for Lynch syndrome or patients who have already been confirmed to have 
Lynch syndrome. If the patient is positive for Lynch syndrome, during a 
counseling call/appointment, the genetic counselor will complete the first 
prompt of the workbook to identify family members with the patient and 
explain the other sections of the workbook. Patients will complete the other 
sections of the work independently. The genetic counselor will notify the 
patient that the workbook creators are interested in hearing feedback on the 
workbook use and if the patient is interested, the genetic counselor will send 
the name, phone number, and email address of the patient to the UNC 
research team via secure email. 
Through the LSI Facebook page, the study team will post an advertisement for 
patients recently diagnosed with Lynch Syndrome. Interested patients will 
reach out to the UNC research team by emailing the address posted in the 
study advertisement. 
 
For all patients referred by a genetic counselor or self-referred, the UNC 
research team will schedule and complete a study enrollment call to answer 
questions, confirm eligibility, and document informed consent to participate in 
a follow up interview and survey. For patients directed to the study from the 
LSI Facebook page advertisement, the UNC research team will provide the 
workbook following the enrollment call and the participant will complete the 
activities in the workbook independently. 
 
The UNC research team will complete the follow up interview and survey 
with patients approximately 4 weeks after they received the workbook from 
their genetic counselor. 

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All patient information will be tracked in a project in UNC’s REDCap. All 
follow up interviews for patients will be conducted via Zoom. All follow up 
surveys for patients will be conducted electronically in REDCap. 
 
For questions specifically related to genetic counseling or care management, 
patient participants should contact their site-specific genetic counselor or 
personal healthcare provider. For all other questions and concerns at any point 
in the study, participants recruited from OSU or UNC should contact the UNC 
research team. Questions about study eligibility and responsibilities should be 
directed to the UNC research team. If participants have questions or concerns 
about their rights as a research subject, or if they would like to obtain 
information or offer input, they can also contact the UNC Institutional Review 
Board at 919-966-3113 or by email to IRB_subjects@unc.edu. 
 
4.3. Schemas 
 
 
 
 
4.4. Duration of Study 
The duration of the study is anticipated to be approximately 24 months. We 
anticipate study enrollment will take approximately 20 months, individual 
patient active participation will last approximately 3 months, and genetic 
counselor active participation will last approximately 9 months. We expect 
patient participants to spend approximately 8 hours engaged in study activities 

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over the approximately 3 months of their enrollment. Hours of patient 
participation may vary by patient’s use of the workbook and particular family 
situation. We expect genetic counselor participants to spend approximately 4 
to 20 hours engaged in study activities over the approximately 9 months of 
enrollment. Genetic counselor time will vary by the number of patients a 
genetic counselor has enrolled into the study. 
 
 
4.5. Intervention Description 
The educational workbook is in a PDF format. The workbook contains a 
series of lessons and exercises on the following topics: 
What is Lynch Syndrome? 
Why should I tell my family members about Lynch Syndrome? 
Who is at risk for Lynch Syndrome and who should I reach out to? 
Create a list of first-degree relatives at risk for inheriting Lynch Syndrome 
What should I tell my family members about Lynch Syndrome? 
Create a script for discussing Lynch Syndrome with family 
What are common concerns family members might express? 
How should I tell my family members about Lynch Syndrome? 
Create a plan to reach out to each family member 
Create goals for talking to family members 
What if my conversation with family didn’t go well? 
What are common terms and questions about Lynch Syndrome? 
How can I manage having Lynch Syndrome? 
Where can I find additional information about living with Lynch Syndrome 
 
4.6. Follow Up 
After a genetic counselor has provided the contact information of an interested 
patients or the patient has directly contacted the research team by email, the 
UNC research team will reach out to the patient in approximately 1 weeks to 
gather informed consent and will conduct a follow up interview and survey 
after approximately 4 weeks. 
 
All interviews will be completed through Zoom using a semi-structured 
interview guide developed by the research team based on the Consolidated 
Framework for Implementation Research.1 The interviews will be conducted 
by the research assistant and a trained interviewer and recorded. The 
recordings will be transcribed for qualitative template analysis to identify 
major themes.2 
 
During the follow-up session, participants will also complete an electronic 
survey to assess the following feasibility concepts: acceptability of 
workbook3, self-efficacy4, Lynch Syndrome knowledge, Lynch Syndrome 
perceived knowledge, cost of workbook use. 

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4.7. Statistical Considerations 
4.7.1. 
Sample Size and Accrual 
With up to five genetic counselors across sites or through LSI, we will 
enroll 15 Lynch Syndrome patients. The study personnel have 
conducted previous qualitative research on genetic testing for cancer 
care, including Lynch Syndrome. Thematic saturation in those studies 
was reached through 15 interviews with patients and providers. Thus, 
we expect to reach thematic saturation on the feasibility of the 
workbook for patients in the template analysis process by enrolling 
approximately 15 patients in the pilot study. Because we are working 
with a small number of patients for a rare disease, we anticipate 
working with a small number of genetic counselors. We expect general 
feasibility feedback from providers on the workbook. 
 
4.7.2. 
Statistical Analysis Plan Data Analysis Plans 
The transcribed qualitative interviews will be double coded using 
template analysis2 in NVIVO, a qualitative data analysis tool, by the 
research assistant and another investigator. Expected themes 
(practicality, integration, demand, and reach) will be a prior coded in 
the transcripts, but the themes will be modified, removed, or additional 
themes will be coded as identified to create a codebook. A final 
codebook will be created and used to double code all interview 
transcripts. We will compile the major themes and subthemes 
identified regarding the workbook feasibility. 
 
During the follow-up session, participants will complete an electronic 
survey to assess the following feasibility concepts. Acceptability of 
workbook3 will be measured through 7 questions for patients rated 
with a scale 1 (very unacceptable) to 5 (very acceptable). A score of 
over 80% suggests an acceptable intervention. Self-efficacy in 
communicating about Lynch Syndrome and the importance of family 
testing4 will be measured through 5 questions rated with a scale 1 
(very low confidence) to 5 (very high confidence). A score of 15 or 
higher suggests moderate to high self-efficacy. Lynch Syndrome 
knowledge will be measured by 7 multiple-choice questions and a 
score of 4/7 or higher suggests moderate to high knowledge of 
workbook users. Lynch Syndrome perceived knowledge will be 
measured by 7 questions rates with a scale 1 (very low confidence) to 
5 (very high confidence) and a score of 21 or higher suggests moderate 
to high perceived knowledge. The cost of workbook use will be 
measured through 19 questions on implementation, intervention, and 
downstream costs of completing the workbook exercises. 
 
One-sample Wilcoxon signed rank tests will be used to compare 

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average acceptability, self-efficacy, knowledge, and perceived 
knowledge levels to the comparison threshold levels to understand 
feasibility of the workbook. 
 
4.8. Expected Risks 
The risks to use of the workbook are minimal. A diagnosis of Lynch 
Syndrome and the task of communicating with family members could be an 
emotional and mental challenge to process and manage. The workbook is 
specifically designed to allow flexible timing so the patient can shape the 
workbook use to fit their emotional and mental needs. 
 
Participant contact and identifying information will be stored in a REDCap 
project in the UNC REDCap environment and will be accessible only to the 
research team to reduce the risk of a breach of confidentiality. Genetic 
counselors will have access to contact and identifying information for their 
patients from the recruitment process and to facilitate study activities. 
 
There is a low risk of economic harm. The Genetic Information 
Nondiscrimination Act of 2008 prohibits discrimination on the basis of 
genetic information in aspects of employment and health coverage. 
 
4.9. Removal of Patients from Protocol 
 
Any patient or genetic counselor who indicates they no longer wish to use the 
workbook or provide feedback on the workbook for any reason can notify the 
Principal Investigator at the UNC or the co-PI at OSU or another member of 
the research team who will inform the site PI and the participant will be 
removed from the study. 
 
 
5. TIME AND EVENTS TABLE 
 
Genetic Counselor 
Introduction to Study 
Guided Exercise at 
Counseling Appointment 
Patient Independent Use 
Patient Informed Consent 
Patient semi-structured 
qualitative 
interview/electronic survey 
 
6. UNANTICIPATED PROBLEMS 

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6.1. Definition 
As defined by UNC’s IRB, unanticipated problems involving risks to study 
subjects or others (UPIRSO) refers to any incident, experience, or outcome: 
 
Is unexpected (in terms of nature, severity, or frequency) given (a) the 
research procedures that are described in the protocol-related documents, such 
as the IRB-approved research protocol and informed consent document; and 
(b) the characteristics of the subject population being studied; 
 
Is related or possibly related to a subject’s participation in the research; and 
Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) related to the 
research than was previously known or recognized. 
6.2. Reporting 
Any UPIRSO that occurs during the conduct of this study and that meets all 
three criteria listed in 6.1 must be reported to the UNC IRB using the IRB’s 
web-based reporting system. 
 
7. STUDY MANAGEMENT 
7.1. Data Management/Audit 
Qualitative interviews will be conducted via Zoom and recorded using Zoom. 
Video will not be used through Zoom interviews. The recording will be 
downloaded, transcribed and deidentified, and stored on a secure network 
drive. The research assistant will also take notes during the interviews and the 
notes will be stored on a secure network drive. The final codebook of themes 
and subthemes identified in the interviews will be stored in a Microsoft Word 
document. 
 
The electronic survey will be administered through REDCap and the collected 
data will be stored in the REDCap system. The survey results will be 
exported and loaded into STATA for statistical analysis. Exported data files 
will be stored on a secure network drive. 
The research will receive a limited waiver of HIPAA authorization to allow 
genetic counselors and the research team to access PHI necessary for the 
recruitment of Lynch Syndrome patients. Specifically, the waiver will approve 
access to patient names, patient ID numbers for UNC patients, telephone 
numbers, email addresses, ages, diagnoses, and dates of diagnosis. Participant 
contact and enrollment information will be collected and stored in REDCap. 
Contact and identifying information for all patients who are referred to the 
UNC research team by their genetic counselor will be collected and stored in 
REDCap. The data for patients who decline to participate or are found 
ineligible during enrollment or withdraw from the study at a later point will 
remain stored in REDCap. The names and contact information of participants 

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and patients who were contacted but not enrolled or withdrew from the study, 
along with linkage codes, will be destroyed by the PI after the study is 
complete. 
 
7.2. Institutional Review Board (IRB) Approval and Consent 
The IRB for UNC will be the IRB of record and have primary oversight for 
this study. Future references to the IRB refer to UNC’s IRB. It is expected that 
the IRB will have the proper representation and function in accordance with 
federally mandated regulations. The IRB will approve the consent form and 
protocol. 
 
In obtaining and documenting informed consent, the investigator should 
comply with the applicable regulatory requirement(s) and should adhere to 
Good Clinical Practice (GCP) and to ethical principles that have their origin in 
the Declaration of Helsinki. 
Before providing informed consent to give feedback on the workbook after 
use, the participants will be given a full explanation of the study and will be 
given the opportunity to review the information sheet. Once this essential 
information has been provided to the patient and the investigator is assured 
that the patient understands the implications of participating in the study, the 
patient will be asked to give verbal consent in a telephone enrollment call. 
Verbal consent will be documented by the UNC research team in REDCap. 
 
Patients recruited from OSU and UNC should contact the UNC IRB with any 
questions. 
 
7.3. Adherence to the Protocol 
Except for an emergency situation in which proper care for the protection, 
safety, and well-being of the study patient requires alternative treatment, the 
study shall be conducted exactly as described in the approved protocol. UNC 
investigators may implement a deviation from, or a change of, the protocol to 
eliminate an immediate hazard(s) to trial subjects without prior UNC IRB 
approval. For any such emergency modification implemented, a UNC IRB 
modification form must be completed by UNC Research Personnel within five 
(5) business days of making the change. 
 
Eligibility single subject exceptions are not permitted for Lineberger 
Comprehensive Cancer Center Investigator Initiated Trials under any 
circumstances. Other types of single subject exceptions may be allowed if 
proper regulatory review has been completed in accordance with Lineberger 
Comprehensive Cancer Center’s Single Subject Exceptions Policy. 
 
According to UNC’s IRB, a protocol deviation is any unplanned variance 
from an IRB approved protocol that (1)Is generally noted or recognized after 
it occurs, (2) Has no substantive effect on the risks to research participants, (3) 

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Has no substantive effect on the scientific integrity of the research plan or the 
value of the data collected, (4) Did not result from willful or knowing 
misconduct on the part of the investigator(s). 
 
An unplanned protocol variance is considered a violation if the variance meets 
any of the following criteria: (1)Has harmed or increased the risk of harm to 
one or more research participants, (2) Has damaged the scientific integrity of 
the data collected for the study, (3) Results from willful or knowing 
misconduct on the part of the investigator(s), (4) Demonstrates serious or 
continuing noncompliance with federal regulations, State laws, or University 
policies. 
 
If a deviation or violation occurs please follow the guidelines below: 
Protocol Deviations: UNC personnel will record the deviation in OnCore® 
(or other appropriate database set up for the study), and report to any sponsor 
or data and safety monitoring committee in accordance with their policies. 
Deviations should be summarized and reported to the IRB at the time of 
continuing review. 
 
Protocol Violations: Violations should be reported by UNC personnel within 
one (1) week of the investigator becoming aware of the event using the same 
IRB online mechanism used to report UPIRSO. 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO: 
Any events that meet the criteria for “Unanticipated Problems” as defined by 
UNC’s IRB (see section 6.1) must be reported by the Study Coordinator using 
the IRB’s web-based reporting system. 
 
7.4. Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be 
originated and documented by the Principal Investigator at UNC. It should 
also be noted that when an amendment to the protocol substantially alters the 
study design or the potential risk to the patient, a revised consent form might 
be required. The written amendment, and if required the amended consent 
form, must be sent to UNC’s IRB for approval prior to implementation. 
 
7.5. Record Retention 
Study documentation includes email correspondence, interview notes, 
recordings, and transcripts, REDCap projects, forms, surveys, and exported 
files to statistical/analysis software, planning documents, and regulatory 
documents (e.g., protocol and amendments, IRB correspondence and 
approval, signed patient consent forms). 
 
Government agency regulations and directives require that all study 
documentation pertaining to the conduct of a clinical trial must be retained by 

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the study investigator. Study documents should be kept on file until three 
years after the completion and final study report of this investigational study. 
 
The Principal Investigator is responsible for the conduct of the clinical trial at 
the site in accordance with Title 21 of the Code of Federal Regulations and/or 
the Declaration of Helsinki. The Principal Investigator is responsible for 
personally overseeing the treatment of all study patients. The Principal 
Investigator must assure that all study site personnel, including sub- 
investigators and other study staff members, adhere to the study protocol and 
all FDA/GCP/NCI regulations and guidelines regarding clinical trials both 
during and after study completion. The Principal Investigator at each 
institution or site will be responsible for assuring that all the required data will 
be collected and provided to the UNC research team. 
 
8. REFERENCES 
(1) Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. 
Fostering implementation of health services research findings into practice: a 
consolidated framework for advancing implementation science. Implement Sci. 
2009;4:50 
(2) King N. Template analysis In: GCS, ed. Qualitative methods and analysis in 
organizational research: A practical guide. Thousand Oaks: Sage; 1998:118-134 
(3) Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing 
of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. 
Appl Nurs Res. 2011;24(1):53-58. 
(4) Carroll JC, Rideout AL, Wilson BJ, et al. Genetic education for primary care 
providers: improving attitudes, knowledge, and confidence. Can Fam Physician. 
2009;55(12):e92-99. 
9. APPENDICES 
9.1. Patient Qualitative Semi-Structured Interview Guide 
Theme #1: Practicality 
Focus A: Understand Let’s Talk complexity 
Interview Questions: 
1. Now that you have used the workbook, what did you think about it? 
a. What did you like? 
b. What did you dislike? 
2. How complex or easy did you find it was to use "Let's Talk"? 
3. How long did it take you to complete the exercises in the workbook? 
a. For patients recruited through LSI: The first prompt covered identifying 
your first-degree relatives. How did identifying your relatives go? Could 
anything have improved the process of identifying relatives to contact? 

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4. How did you feel about the length of the workbook? (too long, too short, just 
right?) 
5. Did you seek help from anyone when you used the workbook? 
6. Was the organization of the exercises logical? 
a. Would you change the order of the workbook sections? 
7. Was there any part of the workbook you found difficult to understand or 
complete? Please explain. 
 
 
Focus B: Understand how Let’s Talk format impacts ease of use 
 
Introduction: Now I’m interested in learning more about how easy or difficult it 
was to use the workbook as a “paper”/PDF format, as well as any suggestions you 
have for improving its design. 
 
1. Would you prefer an online version of the workbook? Why or why not? 
2. What additional materials, if any, would enhance your use of the workbook? 
3. Does the format (e.g. paper-based) of the work workbook create any barriers to its 
use? 
4. Will the format (e.g. paper-based) of the workbook affect your ability to use the 
workbook? 
 
Theme #2: Demand 
Focus A: Understand Let’s Talk value to patients 
 
Introduction: I'm also interested in hearing about how the workbook was valuable 
to you, if it was, and how it impacted the process of communicating with your 
family members. 
 
Interview Questions: 
 
1. Is the workbook effective in enhancing your knowledge of cascade screening (the 
process of testing family members for Lynch syndrome)? 
2. What positive or negative effects have you experienced in using the workbook? 
3. Would you recommend the workbook to other patients? Why or why not? 
 
Theme #3: Reach 
 
Measure #1: Intention to Discuss Lynch Syndrome 
 
Question: On a scale of 1 to 5, 1 being extremely weak and 5 being extremely 
strong, choose the number that represents your intention to discuss Lynch 
Syndrome with your relatives. Explain how you arrived at your chosen number. 
 
OR 

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Measure #2A: Number of Relatives Contacted 
 
Question: How many relatives have you contacted regarding your Lynch 
Syndrome diagnosis after using the workbook? 
 
Measure #2B: What was your overall impression of the conversation with your 
relative? What went well and what could have gone better? 
 
Measure #3: Number of Relatives Who Sought Genetic Testing 
 
Question: Of the relatives you contacted, how many have sought genetic testing? 
Conclusion: Is there anything else you’d like to share before we wrap up today? 
 
9.2. Patient Acceptability Electronic Survey Segment 
 
Acceptability: Please rate how much you agree with the following statements 
(1 – Strongly disagree to 5 – Strongly agree) 
 
The workbook was easy to use. 
The workbook exercises were understandable. 
I enjoyed using the workbook. 
The workbook was helpful in understanding Lynch Syndrome and the 
importance of family genetic testing. 
The workbook was helpful in communicating my diagnosis and information 
about genetic testing with relatives. 
Completing the workbook exercises took an acceptable amount of time. 
Overall, I am satisfied with the workbook. 
 
9.3. Patient Self-Efficacy Electronic Survey Segment 
 
Self-Efficacy: Please rate how confident you are in your ability to do the 
following tasks. 
 
Identify relatives that are good candidates for genetic testing for Lynch 
Syndrome. 
Plan strategies to communicate with relatives about Lynch Syndrome. 
Share your Lynch Syndrome diagnosis with a relative. 
Explain what Lynch Syndrome is and the associated risk of cancer. 
Explain the benefits and risks of genetic testing for Lynch Syndrome to 
relatives. 

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9.4. Patient Knowledge and Perceived Knowledge Electronic Survey Segment 
 
Please answer the following questions about Lynch Syndrome. Then please 
rate your confidence that you chose the correct answer for each question. The 
scale for confidence is Very Sure, Somewhat Sure, Neither Sure nor Unsure, 
Somewhat Unsure, and Very Unsure. 
 
(1) Having Lynch Syndrome means you have a  
 of developing certain 
types of cancer compared to people who don’t have Lynch Syndrome. 
Higher risk 
Lower risk 
Equal risk 
(2) Lynch Syndrome is a genetic condition which means: 
All members of a family will have Lynch Syndrome. 
Lynch Syndrome can be passed down between generations of a family. 
Other family members are not at risk for Lynch Syndrome if a family member 
is diagnosed with Lynch Syndrome. 
 
(3) What are the most common types of cancer associated with Lynch 
Syndrome? 
Skin and bone cancer 
Brain and stomach cancer 
Colorectal and endometrial/uterine cancer 
 
(4) What family members should I discuss my Lynch Syndrome diagnosis 
with? 
No family members. I should only discuss my diagnosis with my doctors. 
My nieces, nephews, aunts, uncles, and cousins 
My parents, children, brothers, and sisters 
 
(5) The best way to manage the risk of cancer after a Lynch Syndrome 
diagnosis is: 
Talk to your doctor about screening for cancer at a younger age and 
possible surgical options to prevent cancer. 
There is nothing I can do to prevent getting cancer if I have Lynch 
Syndrome. 
Continue with my usual care and bring up my Lynch Syndrome diagnosis if I 
get diagnosed with cancer. 
 
(6) Why should people diagnosed with Lynch Syndrome talk to their relatives 
about their diagnosis? 
So their relatives can start increased screening for Lynch Syndrome related 
cancers. 
So their relatives can teach other people about what Lynch Syndrome is 
So their relatives can seek genetic testing to learn their own Lynch Syndrome 

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status and make the best choices for their health. 
 
(7) How do relatives benefit from receiving genetic testing for Lynch 
Syndrome? 
They will know if they should talk with their providers about ways to manage 
Lynch Syndrome and if they should talk to their family members about Lynch 
Syndrome risks. 
They will know when they should start receiving treatment for cancer. 
They will know if they should start annual screenings for all types of cancer. 
 
9.5. Patient Workbook Costs Electronic Survey Segment 
We are interested in understanding what time and resources are necessary to 
use the workbook. The next set of questions are intended to evaluate the time 
and resources needed to use this workbook starting from the genetic 
counseling appointment when you first received the workbook. 
(1) Your genetic counseling appointment took place virtually. Did you have to 
purchase any new tools or resources to access your appointment? If yes, 
please describe. 
 
(2) How far away do you live from your genetic counselor’s physical office? 
Please estimate the distance in miles and the time it would have taken you to 
travel to and from your genetic counselor’s physical office. 
(3) How long did you use the workbook with your genetic counselor? (Please 
round your answer to the nearest 15 minutes.) 
 
(4) Did you have to take time off work to talk with your genetic counselor? 
 
(5) How many hours, if any, did you take off work to meet with your genetic 
counselor to learn about the workbook? 
(6) After your genetic counseling appointment, how long did it take you to go 
through the workbook exercises? (Please round your answer to the nearest 15 
minutes.) 
(7) Did you take any time off work to use the workbook? 
 
(8) How many hours, if any, did you take off work to use the workbook? 
 
(9) Did you use the workbook in a virtual format (e.g. using a computer, tablet 
or phone) or did you print the workbook and fill it out by hand? 
 
(10) Which pages of the workbook did you print? Please describe (e.g. all 
pages, pages 1-5, etc.) 

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(11) After using the workbook, did you spend any additional time using other 
resources for Lynch Syndrome that were mentioned in the workbook? 
 
(12) How long did you spend using the extra resources mentioned in the 
workbook? (Please round your answer to the nearest 15 minutes.) 
 
(13) How many first-degree relatives did you communicate with after using 
the workbook? 
 
(14) Did you take any time off work to communicate with your relatives? 
(15) How many hours, if any, did you take off work to communicate with 
your relatives? 
(16) For each relative that you contacted, please list (1) how you 
communicated with them and (2) how long the entire communication process 
took from initial contact to follow up. Please consider time spent planning, 
communicating, and following up with relatives. 
 
Planning time refers to time spent coordinating/preparing for communication 
with your relatives including activities such as arranging time for a phone call 
or traveling to see a family member. 
Communication time refers to time spent telling your family member about 
your Lynch Syndrome diagnosis. Time might be spent talking to your relative 
over the phone or through a video chat. 
 
Follow up time refers to additional time spent assisting your relatives after 
your initial conversation informing them of your diagnosis. For example, you 
might have spent time sending them additional resources about Lynch 
Syndrome or connecting them to a genetic counselor. 
 
Example Scenario: I spent 10 minutes texting my sister to arrange a time to 
talk on the phone. I called her and we talked for 45 minutes during which I 
told her about my Lynch Syndrome diagnosis and explained why she should 
get tested. She asked for additional materials to learn about Lynch Syndrome, 
so after the call, I spent 20 minutes emailing additional resources to her. In 
the text box, I would list Text/Phone Call/Email as the method of 
communication, 10 minutes of planning time, 45 minutes of communication 
time, and 20 minutes of follow up time. 
 
(17) For each relative that you contacted, please describe your use (if any) of 
the following resources: (1) transportation, (2) Supplies, (3) Food & Drink, (4) 
Other. 
 
Example: For my parent, I drove 30 miles total to and from my parent's house. 

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I also printed out 3 sheets of information on Lynch Syndrome to give to my 
parent. 
 
(18) What was your preferred method of communication with your family 
members and why? 
 
(19) If there were any unexpected costs that you had to pay in using the 
workbook, please describe in the text box. 
 
 
How old are you? 
   18-25 years old 
   26-35 years old 
   36-45 years old 
   46-55 years old 
   56 years old or older 
 
What is your sex? 
   Male 
   Female 
   Other, please specify 
 
What is your annual income? 
   Less than $20,000 
   $20,000 - $34,999 
   $35,000 - $49,999 
   $50,000 - $64,999 
   $65,000 - $79,999 
   $80,000 or greater