Peer-Based Intervention for Genetic Evaluation for Prostate Cancer Among African American Men: The Peer Genetic Study
Phase: NA
Conditions: Healthy Subject, Prostate Carcinoma
Sponsor: Thomas Jefferson University

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THOMAS JEFFERSON UNIVERSITY 
Sidney Kimmel Cancer Center 
 
Peer-Based Intervention for Genetic Evaluation for Prostate Cancer among African American 
Men: The Peer Genetic Study 
 
Principal Investigator: 
 
 
 
Amy E. Leader, DrPH, MPH 
Associate Professor, Medical Oncology 
Sidney Kimmel Cancer Center 
Thomas Jefferson University 
834 Chestnut Street, Suite 314 
Philadelphia PA 19107 
amy.leader@jefferson.edu 
215-955-7739 
 
Co-Principal 
Investigator: 
Veda N. Giri, MD 
Division Chief, Clinical Cancer Genetics, Yale School of 
Medicine 
Assistant Director, Clinical Cancer Genetics, Yale Cancer Center 
333 Cedar Street, WWW214A 
New Haven, CT 06520 
Veda.Giri@yale.edu 
(C) 475-301-5645 
 
Co-Investigator(s): 
Charnita Zeigler Johnson, PhD, MPH 
Assistant Professor, Medical Oncology 
Sidney Kimmel Cancer Center 
Thomas Jefferson University 
834 Chestnut Street, Suite 314 
Philadelphia PA 19107 
charnita.zeigler-johnson@jefferson.edu 
215-955-7739 
 
Wm. Kevin Kelly, DO 
Professor, Medical Oncology and Urology 
Associate Director of Clinical Research 
Leader, Prostate Cancer Program 
Sidney Kimmel Cancer Center 
Thomas Jefferson University 

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1025 Walnut Street, Suite 700 
Philadelphia, PA 19107 
william.kelly@jefferson.edu 
215-503-5455 
 
Leonard Gomella, MD 
The Bernard W. Godwin, Jr. Professor of Prostate Cancer 
Chair, Department of Urology 
Sidney Kimmel Cancer Center 
Thomas Jefferson University 
1025 Walnut Street 
Suite 1112 
Philadelphia, PA 19107 
leonard.gomella@jefferson.edu 
(215) 955-6961 
 
 
Statistician: 
Scott Keith, PhD 
Associate Professor 
Biostatistics 
Department of Pharmacology and Experimental Therapeutics 
1015 Chestnut Street 
Suite 520 
Philadelphia, PA 19107 
ccott.keith@jefferson.edu 
(215) 503-9876 
 
Funding Sponsor: 
Department of Defense 
Prostate Cancer Research Program (PCRP) 
Melissa D. Cunningham, PhD 
PCRP Program Manager 
Joshua D. McKean 
Grants Manager 
301-682-5507 
IND/IDE Holder: 
N/A 
IND/IDE Number: 
N/A 
Study Product: 
N/A 
Protocol IDs: 
JeffTrial # 14300 
PRC # 2019-091E 
IRB Control # 19F.496 

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Version Number: 
Version Date: 
1.0 
04/19/2019 
2.0 
05/03/2021 
2.1 
09/27/2021 
2.2 
11/22/2021 
2.3 
6/22/2022 
2.3.1 
9/28/2022 
3.0 
12/30/2022 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
This document is confidential and the property of THOMAS JEFFERSON UNIVERSITY. 
No part of it may be transmitted, reproduced, published, or used by other persons 
without prior written authorization from the study sponsor. 
 

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Table of Contents (This will be based on the headers in the body of the document. To update 
the table, hit Ctrl+A, and then F9.) 
 
Signature Page .......................................................................................................................... 8 
Statement of Compliance ........................................................................................................... 8 
List of Abbreviations ................................................................................................................... 9 
Study Summary ........................................................................................................................10 
1 
Introduction .........................................................................................................................13 
1.1 
Background Information ..............................................................................................13 
1.2 
Rationale for the Proposed Study ...............................................................................14 
1.3 
Previous Research ......................................................................................................15 
1.4 
Potential Risks and Benefits .......................................................................................16 
1.4.1 Potential Risks.........................................................................................................17 
1.4.2 Benefits ...................................................................................................................17 
2 
Study Objectives .................................................................................................................17 
2.1 
Study Aims .................................................................................................................17 
2.2 
Endpoints/Outcome Measures ....................................................................................17 
3 
Study Design ......................................................................................................................18 
3.1 
Characteristics ............................................................................................................18 
3.2 
Number of Participants ...............................................................................................18 
3.3 
Duration of Study Intervention .....................................................................................18 
Treatment Assignment Procedures ........................................................................................18 
3.3.1 Randomization Procedures .....................................................................................18 

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3.4 
Study Timeline ............................................................................................................18 
4 
Study Enrollment and Withdrawal .......................................................................................19 
4.1 
Eligibility Criteria .........................................................................................................19 
4.1.1 Inclusion Criteria ......................................................................................................19 
4.1.2 Exclusion Criteria ....................................................................................................19 
4.2 
Gender/Minority/Pediatric Inclusion for Research........................................................19 
4.3 
Strategies for Recruitment and Retention ...................................................................20 
4.4 
Participant Withdrawal ................................................................................................20 
4.4.1 Reasons for Withdrawal ..........................................................................................20 
4.5 
Premature Termination or Suspension of Study ..........................................................20 
5 
Study Intervention ...............................................................................................................20 
5.1 
Study Behavioral or Social Intervention(s) Description ................................................21 
6 
Study Procedures and Evaluations .....................................................................................21 
6.1 
Specification of Safety Parameters .............................................................................26 
6.1.1 Unanticipated Problems ..........................................................................................26 
6.1.2 Adverse Events .......................................................................................................26 
6.2 
Safety Reporting .........................................................................................................27 
6.2.1 Reporting to IRB ......................................................................................................27 
6.2.2 Reporting to SKCC DSMC ......................................................................................28 
7 
Study Oversight ..................................................................................................................28 
8 
Clinical Site Monitoring and Auditing ...................................................................................28 
9 
Statistical Considerations ...................................................................................................28 

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9.1 
Study Hypotheses .......................................................................................................28 
9.2 
Analysis Plans ............................................................................................................29 
9.3 
Sample Size Considerations .......................................................................................29 
10 
Source Documents and Access to Source Data/Documents ..........................................30 
11 
Quality Control and Quality Assurance ...........................................................................31 
12 
Ethics/Protection of Human Participants .........................................................................31 
12.1 
Ethical Standard .........................................................................................................31 
12.2 
Institutional Review Board ...........................................................................................32 
12.3 
Informed Consent Process ..........................................................................................32 
12.4 
Exclusion of Women, Minorities, and Children (Special Populations) ..........................32 
12.5 
Participant Confidentiality............................................................................................32 
12.6 
Future Use of Stored Specimens and Other Identifiable Data .....................................33 
13 
Data Handling and Record Keeping ...............................................................................33 
13.1 
Data Management Responsibilities .............................................................................33 
13.2 
Data Capture Methods ................................................................................................33 
13.3 
Study Records Retention ............................................................................................33 
13.4 
Protocol Deviations .....................................................................................................34 
14 
Study Finances ...............................................................................................................34 
14.1 
Funding Source ..........................................................................................................34 
14.2 
Conflict of Interest .......................................................................................................34 
14.3 
Participant Stipends or Payments ...............................................................................34 
15 
Publication and Data Sharing Policy ...............................................................................34 

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16 
Literature References .....................................................................................................35 
Appendices ...............................................................................................................................38 
 

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Signature Page 
For multi-site studies, the protocol will be signed by the clinical site investigator who is 
responsible for the day to day study implementation at his/her specific clinical site. For a 
clinical trial involving an Investigational New Drug (IND), this is the individual who signs 
the Form FDA 1572 for a drug or the investigator agreement for a device. 
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 US federal 
regulations and ICH guidelines. 
Principal Investigator: 
Signed: 
 
Date:  09/28/2022 
Name: 
Amy E. Leader, DrPH, MPH 
 
Associate Professor, Population Science, Medical Oncology  
Associate Director, Community Integration, Sidney Kimmel Cancer Center  
Teaching Faculty, Public Health Program, College of Population Health 
 
 
 
Statement of Compliance 
This study will be conducted in accordance with the International Conference on Harmonisation 
guidelines for Good Clinical Practice (ICH E6), the Code of Federal Regulations on the 
Protection of Human Subjects (45 CFR Part 46), and Thomas Jefferson University research 
policies 
 
 
 

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List of Abbreviations 
 
AA: African American 
ASCO: American Society of Clinical Oncology 
BRCA1, BRCA2, ATM, PALB2, CHEK2, NBN, the DNA mismatch repair genes: cancer risk 
genes  
GEM: Genetic Evaluation of Men 
GU: Genitourinary 
MEE: Motivational, Educational, Entertainment Productions, Philadelphia, PA 
NCCN: National Comprehensive Cancer Network 
PARP: Poly ADP ribose polymerase 
PCA: Prostate cancer 
RESPOND: Research on Prostate Cancer in Men of African Ancestry 
SURE: Decisional conflict scale 
TPB: Theory of Planned Behavior 
US: United States 
 
 

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Study Summary 
 
Title: 
Peer-Based Intervention for Genetic Evaluation for Prostate Cancer 
among African American Men: The Peer Genetic Study 
Précis: 
The study will evaluate the impact of a peer-educator led, clinic-
based intervention to educate men about their risk of prostate cancer 
and facilitate genetic testing for prostate cancer risk assessment 
Objectives: 
 
Aim 1: Explore barriers to genetic testing and opportunities for 
intervention among AA males who live in low-resource communities 
through focus groups with AA men and interviews with key 
stakeholders.   
Aim 2: Implement a community-based peer health education 
intervention. AA male peer health educators will be trained in PCA 
genetics, and a randomized trial will be implemented for 176 AA males 
in the community of peer health education vs. mailed informational 
materials.  
Aim 3: Evaluate the impact of peer health education. The primary 
outcome will be decisional conflict regarding consideration of genetic 
testing. Exploratory outcomes will include rates of AA men meeting 
NCCN genetic testing guidelines and assessment of genetic counseling 
experience among AA men who opt for genetic testing. 
 
Population: 
176 men will be randomized to receive either: (1) a peer-led, clinic 
based educational intervention or (2) standard written materials 
about personal and family history of prostate cancer.  Eligible men 
are between the ages of 35-69 and can speak and read English 
comfortably. 
Phase: 
N/A: Randomized controlled trial of a behavioral intervention 
Number of Sites: 
CityLife Neighborhood Clinic 
1010 W. Lehigh Avenue Philadelphia, PA 19133 
 
AND 
 

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Community and Church based organizations in and around 
Philadelphia, PA 
Description of 
Intervention: 
Men in the intervention group (n=88) will attend a peer-led education 
session about PCA genetic testing while men in the control group 
(n=88) will receive mailed informational materials about PCA genetic 
testing.  Men in either group who wish to pursue genetic testing will 
be referred to the Clinical Cancer Genetics Program at SKCC.  The 
cost of genetic testing will be covered for all men. 
Study Duration: 
4 years: July 1, 2019- June 30, 2024 
Participant 
Participation 
Duration: 
Estimated time is 1-3 months 
Estimated Time to 
Complete 
Enrollment: 
3.5 years (April 2020-October 2023) 

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Schematic of Study Design: 
Prior to  
Enrollment 
 
 
 
 
 
 
 
 
 
 
Visit 1 
Baseline  
 
 
 
Visit 2 
 
 
 
Visit 3 
2-months  
After V2 
 
 
 
 
 
 
 
 
 
 
 
 
 
(Decisional Conflict, Knowledge of PCA and genetic testing, intentions to receive 
genetic testing (if appropriate) 
Total N: 176 
Perform baseline assessments. 
(Decisional Conflict, Knowledge of PCA and genetic testing, intentions to receive 
genetic testing (if appropriate) 
Randomize 
Arm 2 
Arm 1 
Study Intervention (Peer-Led, In-Person Session or Standard Materials by Mail) 

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1 Introduction 
1.1 
Background Information 
African American (AA) males have some of the highest rates of prostate cancer (PCA) incidence 
and death in the US.1 Indeed, AA males have over twice the rate of mortality from PCA compared 
to any other race group.1 While the causes of this disparity in PCA mortality for AA men likely 
include a combination of biologic, behavioral, and environmental factors, a deep understanding of 
the interplay of these factors lending to PCA-related death remain largely unknown. In fact, a 
major study as part of the Cancer Moonshot led by the National Cancer Institute, National Institute 
of Minority Health and Health Disparities, and Prostate Cancer Foundation (RESPOND - Research 
on Prostate Cancer in Men of African Ancestry) is now underway to gain greater understanding of 
PCA aggressiveness among AA men.2 Thus, reducing PCA disparities for AA men is now taking 
major national priority. To maximize the impact of such studies will require novel groundwork in 
community settings. 
Meanwhile, genetic testing is revolutionizing PCA care. Over the last 2-3 years, research 
studies have provided ground-breaking insights into high rates of germline (inherited) mutations 
(12-15%) among men with metastatic PCA.3,4 Our research group extended the scope of insights 
into inherited genetic mutations, reporting rates of 5-7% among men with earlier stage PCA 
particularly with strong family cancer history.5 Mutations in multiple genes have been reported in 
these prior studies  including BRCA1, BRCA2, ATM, DNA mismatch repair genes, NBN, and 
CHEK2.3-5 Furthermore, men with PCA and specific genetic mutations have been shown to have 
improved responses to targeted therapy with PARP inhibitors,6  leading the FDA to grant 
“Breakthrough Therapy” designation for olaparib (a PARP inhibitor) for men with BRCA1, 
BRCA2, or ATM mutations. These landmark insights led our institution to host and publish the first 
international consensus conference on the “Role of Genetic Testing for Inherited Prostate Cancer 
Risk” to set forth a comprehensive framework for genetic testing for men with PCA.7 
Subsequently, the National Comprehensive Cancer Network (NCCN) rapidly expanded genetic 
testing guidelines to encompass testing multiple genes including BRCA1, BRCA2, ATM, PALB2, 
FANCA, and DNA mismatch repair genes in all men with metastatic PCA, men with earlier stage 
disease who have strong family cancer history, or men unaffected with PCA who are making 
screening decisions and have a strong family cancer history.8-10 Thus, genetic results are now 
informing precision treatment for metastatic PCA, management for early-stage disease, and PCA 
screening discussions among men unaffected with PCA.8-10 

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A major concern is that expansion of genetic testing for PCA will increase PCA disparities 
for AA men. In fact, genetic information in AA men is a major gap in knowledge due to low 
representation in prior genetic studies.3-5 Patients from ethnic minority groups participate less 
frequently in genetic testing due to lack of awareness or understanding, cultural beliefs, financial 
limitations, fear of discrimination, and mistrust in the healthcare system.11 This is of particular 
concern in the Philadelphia region, where African Americans account for up to 44% of our 
catchment area, and PCA mortality exceeds the national average.12Addressing awareness, barriers 
to consideration of genetic evaluations, and engagement in informed decision-making for genetic 
testing for PCA among AA men is therefore imperative, since testing is increasingly informing 
screening strategies for unaffected men and treatment for men with PCA.8-10  
Peer health education has been used to access ‘hard to reach’ groups with the participation 
of those who are of a similar age, background or interest.13 Typically, there are four essential 
elements of peers: (1) they share specific characteristics, experiences, or circumstances and are 
selected because they are from the same community or belong to a specified subgroup; (2) their 
shared qualities increase the effectiveness of the services they provide; (3) they lack professional 
training or status in the scope of their work, but are trained to deliver a specific intervention; and 
(4) they function intentionally based on standardized protocols, and therefore their interactions 
extend beyond their existing social network.13 Peer-led dialogue groups have the potential to 
increase families' and communities' uptake of recommended health practices.14,15  Facilitated 
discussions allow group members to actively participate in the learning process and share their 
experiences and knowledge with other group members, as well as engage in group problem-
solving.16 Hearing what group members know, think, and do can lead other members to positively 
change their attitudes and behaviors.17 The use of peer interventions has been demonstrated as 
effective, regardless of the health behavior, the population or demographics of individuals who are 
the target audience, although most have been related to HIV testing, alcohol and substance abuse, 
physical activity, heart disease, and diabetes.18  
 
1.2 
Rationale for the Proposed Study 
As an increasing number of people seek information about cancer genetics, there is a 
growing need for competent and culturally relevant dissemination of information. It is well 
documented that low-income, low-literacy individuals are less likely to participate in genetic 
counseling and genetics research,19 which only continues to perpetuate health disparities.  Previous 
research indicates that individuals with reduced health literacy often report feeling overwhelmed 
during a genetic counseling session due to too much information, the complexity of the 
information, unintentional inhibition of patient engagement and interaction, and vague discussions 
about screening and testing resources.20 Peer-led programs are uniquely suited to fill part of this 
gap by educating individuals about basic cancer genetics in a way that is understandable and 
relatable for those involved. 

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The proposed study titled “Peer-Based Intervention for Genetic Evaluation for Prostate 
Cancer among African American Men: The Peer Genetic Study” will identify and address barriers 
and beliefs regarding genetic testing for PCA among AA men in the Philadelphia region. The study 
will build upon strong community partnerships supported by prior DOD funding and link to a first-
in-field genetic counseling and genetic testing program. Leveraging an invested cadre of AA male 
peer health educators, the study will train them in the principles and practice of genetic testing, to 
implement a peer education intervention in a community clinic setting.  We aim to study the impact 
of peer education, compared to the standard approach of printed educational materials, in reducing 
decisional conflict about genetic testing.  Results of the study will inform health system approaches 
and health policy, regarding peer education. We expect the results to ultimately reduce PCA 
disparities for AA men by promoting responsible engagement in informed decision-making for 
genetic testing to guide PCA screening and treatment. Therefore, the study will create a 
community-based sustainable pipeline to address the overarching challenge of engaging AA males 
in cancer genetics research to define the biology of lethal prostate cancer, namely germline 
genetics of AA men.  Results of the study will ultimately inform PCA screening and identification 
of novel targeted agents for population-specific precision treatment of PCA to reduce death among 
AA men.   
1.3 
Previous Research  
The current proposal leverages expertise in clinical cancer genetics, PCA risk assessment, 
PCA treatment, community-based health interventions, and population science towards the goal 
of developing, implementing, and assessing a novel peer-based PCA genetic education program 
for AA males in community health clinics. Limited genetic data has hindered tailored PCA 
screening and the development of targeted therapies to improve PCA outcomes in AA men, 
necessitating novel approaches to genetic evaluation for AA men as proposed here.  
 
Leadership in prostate cancer genetic testing. Dr. Veda Giri is a medical oncologist with 
specialization in clinical cancer genetics. She has been a thought leader in conducting multigene 
testing for inherited PCA through the Genetic Evaluation of Men (GEM) study (Partially funded 
by PA Department of Health grant).5 Dr. Giri started the first Men’s Genetic Risk Clinic in the US 
in 2014 focused on genetic evaluation of inherited PCA.21  Dr. Giri also co-chaired an international 
consensus conference that published a comprehensive framework for genetic evaluation of PCA, 
which noted that genetic testing among AA males is a high priority due to lack of genetic data in 
this population.7 Dr. Giri’s work has contributed novel insights into the germline spectrum of 
inherited PCA from multigene testing.5 Furthermore, Dr. Giri and Dr. Leader collaborated on a 
project of understanding of genetic test results among men and co-authored the publication.22  
 

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Forefront of community-based PCA education for African Americans. Dr. Amy Leader is a 
population scientist and a current recipient and Co-PI of a Synergistic IDEA Award (#PC140667) 
(Title: A Neighborhood Based Intervention to Reduce PCA Disparities) (Funded 10/15-9/18). Dr. 
Giri is a Co-Investigator on the funded study.  Specific Aims for the funded study were to:(1) 
identify neighborhoods with disproportionately high rates of advanced PCA and describe patient- 
and neighborhood-level risk factors associated with the high-risk neighborhoods; (2) develop, 
using a mixed methods approach, a peer-led educational intervention about PCA for men who live 
in high risk neighborhoods; (3) test the impact of the intervention on levels of knowledge, anxiety, 
and informed decision making about PCA screening; (4) observe rates of  PCA screening in the 
intervention and control groups.  The research team successfully enrolled 240 AA males into this 
study, demonstrating its ability to engage and collaborate with the AA communities of 
Philadelphia.  
Collaboration of successful prior research and expertise for the current proposal. The PI (Dr. 
Giri) and Co-PI (Dr. Leader) will now leverage their successful experience with genetic education 
and counseling, genetic testing, and community-based research toward addressing barriers and 
developing implementation of genetic evaluation for PCA for AA males from community health 
clinics in underserved communities in the Philadelphia area, which has some of this highest burden 
of lethal PCA in the US.12 The specific aims of the current proposal are designed to gain 
information on challenges and barriers to uptake of genetic assessment for PCA among AA males, 
develop a peer education intervention for community health clinics with predominantly AA 
population, and assess the value of peer education in decisional conflict to seek genetic testing.  
Knowledge gained from implementing Study # PC140667 will ensure the likelihood of success of 
the proposed study in the following ways: (1) We have engaged a diverse group of community 
partners to form a network of grass-roots and professional organizations which will form the 
foundation of community engagement and outreach crucial for its success; (2) We developed a 
specialized curriculum for training peer health educators, which will serve as the foundation for 
training the peer health educators in PCA genetic assessment for the proposed study; (3) Five peer 
health educators from # PC140667 will be readily trained and engaged in the proposed study.  
Thus, the current proposal will make major strides to addressing barriers to awareness and 
implementation of genetic evaluation for AA males to ultimately reduce death from PCA. 
 
1.4 
Potential Risks and Benefits 

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1.4.1 Potential Risks 
There are very few risks expected with this educational intervention.  Participants may experience 
anxiety when talking or thinking about their personal or family risk of cancer.  There may be a 
loss of confidentiality when discussing your medical history with a peer health educator.  All 
efforts to reduce these risks, whether psychosocial or privacy-related, will be taken.   
1.4.2 Benefits 
Potential benefits to patients include learning more about PCA and how one’s personal or family 
history of disease may increase one’s risk of PCA.  Also, having access to genetic testing may 
benefit some participants.   
2 Study Objectives 
2.1 
Study Aims 
 
Aim 1: Explore barriers to genetic testing and opportunities for intervention among AA males who 
live in low-resource communities through focus groups with AA men and stakeholders.   
 
Aim 2: Implement a PCA genetics education and testing program for AA men who live in low-
resource communities.  Eligible men will be randomized to either the intervention group (peer-led 
health education sessions) or the control group (mailed materials). 
  
Aim 3: Evaluate the impact of the intervention.  The primary outcome is decisional conflict 
regarding consideration of genetic testing. Exploratory outcomes include rates of AA men meeting 
NCCN genetic testing guidelines and assessment of genetic counseling experience among AA 
men. 
 
2.2 
Endpoints/Outcome Measures 
Aim 1:  Focus groups will uncover knowledge and awareness of prostate cancer; understanding 
of genetic testing; perceptions of genetic testing; risks and benefits of testing 
 
Aim 2:  Outcome will be the design of a feasible intervention to employ in a community-practice 
setting. 

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Aim 3:  Analysis of intervention data will determine: extent of decisional conflict; knowledge of 
prostate cancer and genetic testing for prostate cancer risk; individual assessment of prostate 
cancer risk; intentions to seek genetic testing (if appropriate) 
3 Study Design 
3.1 
Characteristics 
Aim 1: Two focus groups consisting of men who are current patients of CityLife Neighborhood 
Clinic or who live in the surrounding neighborhood 
Aim 2/3:  Design and implementation of an educational intervention to increase knowledge 
about PCA, the role of personal and family history as risk factors for PCA, and the purpose of 
genetic testing for PCA risk, if appropriate. 
3.2 
Number of Participants 
Aim 1: 2 focus groups, each with 8-10 men 
Aim 2/3: 176 men 
3.3 
Duration of Study Intervention 
Aim 1: Each focus group will last approximately 1.5 hours 
Aim 2/3: Each participant will be in the study for approximately 2 months 
Treatment Assignment Procedures 
3.3.1 Randomization Procedures  
Aim 2/3: At the time of consent and enrollment into the study, each participant will be randomly 
assigned to participate in the intervention arm or the control arm.  A randomization scheme will 
be provided by the study biostatistician. 
3.4 
Study Timeline 
 
Year 1 
Year 2 
Year 3 
Convene Advisory Board 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 

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IRB Approval of Study 
x 
 
 
 
 
 
 
 
 
 
 
 
Conduct Focus Groups and Stakeholder Interviews 
 
x 
 
 
 
 
 
 
 
 
 
 
Recruit and Train Peer Health Educators 
 
 
x 
 
 
 
 
 
 
 
 
 
Develop Intervention Materials 
 
 
x 
 
 
 
 
 
 
 
 
 
Implement Intervention; Refer to Genetic Testing 
 
 
 
x 
x 
x 
x 
x 
x 
 
 
 
Data Cleaning and Analysis 
 
 
 
 
 
 
 
 
x 
x 
 
 
Disseminate Study Results 
 
 
 
 
 
 
 
 
 
 
x 
x 
 
4 Study Enrollment and Withdrawal 
4.1 
Eligibility Criteria 
4.1.1 Inclusion Criteria 
Aim 1: Men will be eligible to participate in a focus group if they are between the ages of 35 and 
69 and are able to read and speak English comfortably.  Men with or without a personal or 
family history of PCA are eligible to participate in a focus group.  Men do not need to be an 
established patient at CityLife Neighborhood Clinic in order to participate in a focus group. 
Aim 2/3:   Men will be eligible to participate in the intervention if they are between the ages of 
35 and 69 and are able to read and speak English comfortably.  Men with or without a personal 
or family history of PCA are eligible to participate.  Men do not need to be an established patient 
at CityLife Neighborhood Clinic in order to participate. 
4.1.2 Exclusion Criteria 
Aim 1: Men who are not between the ages of 35 and 69, or who do not read or speak English 
comfortably will not be able to participate in a focus group. 
Aim 2/3:   Men who are not between the ages of 35 and 69, or who do not read or speak English 
comfortably will not be able to participate in the intervention.  Additionally, men who 
participated in a focus group will be excluded from participating in the intervention. 
4.2 
Gender/Minority/Pediatric Inclusion for Research  

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Given that CityLife Neighborhood Clinic is located in a diverse neighborhood and has a diverse 
patient population, we expect that a large proportion of the study population will be African 
American and Hispanic males.  Women are not eligible to participate in the study as they are not 
at risk for PCA.  Children are excluded from participating, as their risk of PCA is non-existent. 
4.3 
Strategies for Recruitment and Retention 
4.4 
Participant Withdrawal 
4.4.1 Reasons for Withdrawal 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may terminate a study participant’s participation in the study if: 
• Any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurs such that continued participation in the study would not be in the best 
interest of the participant. 
• The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
4.5 
Premature Termination or Suspension of Study 
This study may be suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party.  If the study is prematurely terminated or 
suspended, the principal investigator will promptly inform the IRB and will provide the reason(s) 
for the termination or suspension.  
Circumstances that may warrant termination include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants. 
• Insufficient adherence to protocol requirements. 
• Data that is not sufficiently complete and/or evaluable.  
• Determination of futility. 
5 Study Intervention 

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5.1 
Study Behavioral or Social Intervention(s) Description 
The goal of Aim 1 is to conduct 2 focus groups to identify gaps in awareness, cultural beliefs, and 
barriers to considering genetic counseling and genetic testing for PCA.  Key themes identified 
during the focus groups will inform the development of the behavioral intervention in Aim 2. The 
goal of Aim 3 is to evaluate the impact of the intervention, focusing on outcomes related to 
decisional conflict about genetic testing and knowledge of PCA. 
 
6 Study Procedures and Evaluations 
 
Aim 1: Focus Groups 
We will conduct two focus groups of approximately 8 AA men each, recruited from the patient 
population at CityLife Clinic or the surrounding neighborhood.  MEE Productions, Inc. will 
coordinate and moderate both of the focus groups.  MEE Productions, Inc. is a nationally 
recognized communications, market research and social-marketing firm with roots in Philadelphia 
that specializes in developing cost-effective, cutting-edge and culturally relevant messages for 
hard-to-reach, low-income and underserved audiences. The study team has significant experience 
in working with MEE Productions, Inc. on a prior research study [DOD Synergistic IDEA Award 
(#PC140667)].  The goal of the focus groups will be to gather information on awareness, 
understanding, attitudes, and challenges to considering genetic testing for PCA. Factors such as 
knowledge of family cancer history, relevance of genetic testing in health, and competing risks 
and pressures will also be explored.   
 
Prior to the start of each focus group, each participant will provide informed consent.  Focus group 
discussions will be audio recorded and transcribed by a professional transcription company. The 
transcriptions will be verified for accuracy by a member of the research team who attended each 
focus group.  Transcripts will be analyzed by iterative rounds of coding by at least two members 
of the research team, where specific themes and trends will be identified within each transcript and 
discussed by the research team until final consensus is reached. Themes will be identified as topics 
that consistently occur across transcripts, as well as similarities and differences between 
transcripts.23 NVivo software will be used to perform thematic content analysis. Participants will 
be compensated $25 for attending a focus group. 
 
Aim 2/3: Behavioral Intervention 

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Recruitment and training of peer health educators. The study team has built strong AA 
community relationships from work on a prior funded DOD grant [Synergistic IDEA Award 
(#PC140667)]. Peer educators from this prior grant will be re-contacted to participate in the Peer 
Genetic Study. A total of five peer educators will be recruited. If prior peer educators are not 
available to commit to the study, additional avenues to recruit peer health educators will be through 
CityLife Clinics or MEE Productions, Inc. Men need not have previous heath care experience to 
be trained as a peer educator.  Dr. Giri or Dr. Leader will lead the educator training sessions. 
Culturally relevant issues will be addressed throughout the 9 training sessions, as they pertain to 
each of the training modules. Questions and concerns from peer health educators will also be 
addressed throughout the training.  Peer educators will also complete human subjects training to 
be able to collect participant subject data during the intervention.  Peer educators will attend 
training sessions in person, typically over the dinner meal, and will be compensated $20/hour of 
training time.  
 
 Development of genetic training materials. Content of the training materials for peer educators 
will be adapted from ASCO’s Practice Guideline Genetics Toolkit.24 The toolkit modules will be 
adapted as follows: (1) understanding hereditary cancer, (2) assessing hereditary cancer risk, (3) 
considerations of genetic testing and results, (4) management PCA and PCA screening based on 
genetic test results, (5) financial and ethical considerations of genetic testing, (6) cultural issues to 
address regarding genetic testing among AA males, (7) PCA risk and lifestyle modifications, (8) 
implications of genetic testing on family members, and (9) case scenarios.  Based on input from 
the study team, MEE Productions, Inc. will develop print materials for the training sessions 
covering the aforementioned content. 
 
Assessment of competency. To assess peer educator competency prior to the start of the 
intervention, we will adapt evaluation materials from the International Society of Nurses in 
Genetics 2011 Consensus Panel and survey on knowledge and understanding of PCA genetics and 
genetic results.22,25 Example true/false assessment questions will include:  (1) Factors such as 
personal behavior (diet, exercise) and environmental conditions (exposures) can raise the risk of 
getting prostate cancer; (2) Men with a family history of prostate cancer should also consider other 
factors that could raise the risk of getting prostate cancer, such as diet or exposures; (3) A family 
history of prostate cancer can raise the risk of getting prostate cancer; (4) Family history of 
additional cancers, such as breast cancer, can raise the risk of getting prostate cancer; (5) Having 
a history of prostate cancer on his mother’s side of the family, can raise the risk of a man getting 
prostate cancer; (6) A genetic test can tell if someone will definitely get prostate cancer in the 
future; (7) Genetic testing may still be important even if a man has prostate cancer; (8) Patients 
with one cancer can be at risk for getting other cancers if the patient has a genetic mutation. 
Additional multiple-choice questions will include: (1) What types of genetic test results 
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cancer? (3) How can genetic testing be used in prostate cancer screening discussions? (4)  What 
should a man know about genetic discrimination laws before proceeding with genetic testing? (5) 
What additional cancer risks might be learned from genetic testing for prostate cancer?  Peer health 
educators will be expected to score correctly on 80% or more of the questions to proceed with the 
intervention in Aim 3. Any areas of deficiency in understanding will be addressed by the study 
team in a group format or one-on-one with a peer health educator.  
 
Participant Recruitment and Study Enrollment. MEE Productions, Inc. will develop culturally-
tailored recruitment materials including flyers, posters and email blasts for CityLife Clinics to send 
to their AA male patients. The goal is to enroll 176 men in the study.  We are anticipating a roughly 
15% attrition rate over the course of the intervention, producing a final sample size for analysis of 
150 men.  We anticipate, based on our previous experience in community-based research, that we 
will have to screen about 10 times that number, or about 2000 men, to reach our study recruitment 
goal of 176 men.  The research team will work with CityLife Clinic to mail a study recruitment 
letter to eligible males at their clinic, inviting them to participate. A toll-free, local telephone 
number will be included in the letter for men to opt-out of the study.  After two weeks, any male 
who has not opted out will receive a telephone call from a member of the research team to screen 
for study eligibility. We will supplement our recruitment at CityLife Clinic by grassroots outreach 
in the neighborhood surrounding the clinic, to invite men not associated with the clinic to 
participate.  We will promote the study at community recreation centers, public libraries, housing 
complexes and apartments, local non-profit organizations, barbershops, and employment agencies. 
Men who see the flyers or a member of the study team in the community can also call the toll-free, 
local number to screen for eligibility and participate.  This is a similar approach that the study team 
was successful in using for the previously funded DOD study.   
 
Study eligibility. Men who call the telephone number associated with the study or are who 
approached in the community will be screened for eligibility by the study research manager.  Any 
AA male with or without prostate cancer between the ages of 35-69 will be eligible for the study. 
Men must speak and read English comfortably, as all study materials will be in English.  Men do 
not need to be established patients at CityLife Clinics to participate.   
 
Study Randomization and Informed Consent.  Those who are eligible to participate will be 
randomized to either the intervention or the control arm.  Men randomized to the intervention arm 
will be scheduled to attend a health education session hosted at CityLife Clinic or virtually, while 
men who are randomized to the control arm will receive educational materials about PCA genetic 
testing in the mail or in person. All men who agree to participate will be read a consent statement 
over the phone or in person and will verbally agree to consent to participate.  A copy of the consent 
statement will be provided to them for their records. 
 

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Baseline Survey.  All participants will complete a brief baseline questionnaire over the telephone 
or in person with the study manager.  Items to be assessed at baseline include knowledge about 
prostate cancer, their personal family cancer history, knowledge of genetic testing and screening, 
attitudes towards genetic testing, subjective norms about genetic testing, decisional conflict about 
genetic testing, and intentions to seek genetic counseling.  Knowledge about PCA genetics and 
genetic testing will be measured using a 14-item scale, recently published by the study team in a 
population of men undergoing genetic testing.22 The measure for decisional conflict will be the 
SURE Decisional Conflict Scale, a low-literacy validated measure to screen for decisional 
conflict.26 The four questions encompass the following with Yes/No responses: (1) Do you feel 
sure about the best choice for you? (2) Do you know the benefits and risks of your options? (3) 
Are you clear about which benefits and risks matter most to you? (4) Do you have enough support 
and advice to make a choice?  Demographic data related to age, race/ethnicity, family history of 
prostate or other cancer, and other pertinent health information will be collected.   
 
Study Intervention. 
Intervention Arm: Men who are randomized to the intervention arm will be invited to a 
peer health education session, either in-person or virtually.  Eighty-eight of the 176 men will be 
randomized to this group, and we will host sessions that attract roughly 6-8 men at a session.  Our 
previous experience conducting peer health education sessions found that 6-8 men was an ideal 
attendance level, as it allowed for interaction and discussion but did not feel overwhelming. Each 
session will be facilitated by two peer educators, who can share responsibilities and interact with 
each other.  We expect to offer 12-15 sessions, or roughly 1-2 sessions per month.  Sessions will 
be scheduled at various times of the day and days of the week, to accommodate men with varying 
schedules and commitments. Each peer educator will be compensated for 2 hours of time to run a 
session from start to finish, being compensated at $20/hour. 
First, the peer educator will introduce the topic of PCA, so that men understand the disease 
and how it relates to their health.  The educator will lead a discussion regarding PCA risk, family 
history, PCA genetics, considerations of genetic testing, implications of genetic testing on family 
and self, and financial and ethical considerations.  The discussion is meant to be interactive, with 
men sharing stories and experiences and peer educators answering questions and clarifying facts. 
All information will be delivered in a culturally appropriate manner by peer educators who are 
from the community they are serving.  Immediately following the discussion, men will complete 
a post-survey to measure short-term changes knowledge about prostate cancer and genetic testing, 
thoughts about cancer, in decisional conflict about genetic testing, attitudes toward genetic testing, 
subjective norms about testing, and intentions to seek genetic testing.  We will also get feedback on 
the peer-led session.   
Control Arm: After providing informed consent and completing the baseline survey over 
the telephone or in-person, eighty-eight men will be randomized to this arm and each man will 
receive an educational booklet.  It is expected that materials will be mailed within 24 hours of the 

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telephone call or provided to the participant in person.  The information will cover PCA risk, 
family history, PCA genetics, considerations of genetic testing, implications of genetic testing on 
family, and financial and insurance considerations.  
 
Endpoint Survey. All men, regardless of study arm, will complete an endpoint survey.  A member 
of the study team will call each participant two months after either attending a peer education 
session (intervention arm) or being mailed the educational print materials (control arm).  Previous 
research shows that two months is an adequate amount of time to digest the material and act upon 
it, if desired.27 The majority of items on the baseline survey, except for the demographic 
information, will be repeated on the endpoint survey. Participants who are not reached by 
telephone will be contacted by mail and by email to attempt to retain the maximum number of 
participants over time. 
 
Participant Compensation. Each man who participates in all study-related activities will receive 
$50 over the course of the study.  Men in the intervention group will receive $25 for completing 
the baseline survey via the mail and $25 for completing the endpoint survey over the telephone at 
two-months post-intervention. Men in the control group will receive $25 in their mailed packet of 
materials after completion the baseline survey and an additional $25 for completing the endpoint 
survey over the telephone at two-months post-intervention.   
 
Referral to Genetic Counseling. Men from both groups who decide they want to proceed with 
genetic counseling and genetic testing will be given the number to contact the Cancer Risk and 
Genetics Program at Sidney Kimmel Cancer Center at Jefferson, led by Dr. Giri (study PI). Once 
men contact the Genetics Program, an intake will be performed to determine if they meet personal 
or family history criteria for genetic testing. Current NCCN criteria for PCA genetic testing8-10 
include any of the following: (1) personal history of advanced or metastatic PCA, (2) family history 
of brother, father, or multiple family members diagnosed with PCA at age <60, (3) first-degree, 
second-degree, or third-degree relatives with cancers of the breast, ovary, prostate, pancreas, 
colon, or endometrium suggestive of a hereditary cancer syndrome. Men will then be scheduled 
for a genetic counseling visit to formally cover information regarding genetic testing such as how 
cancers can be inherited, types of genetic test results, and implications for the man and his 
family.21,28,29 Once the man agrees to proceed with testing, a saliva sample will be collected and 
sent to Invitae, a CLIA-certified and experienced clinical genetic testing laboratory to perform 
multigene testing. Genes to be tested by sequencing and deletion/duplication testing will include 
BRCA1, BRCA2, ATM, PALB2, CHEK2, NBN, the DNA mismatch repair genes, and additional 
genes as needed. Invitae follows ACMGG guidelines for variant classification and all standard 
procedures for variant reclassification updates.30 Since men in this study may be underinsured, the 
study will pay for the cost of genetic testing for all men who undergo genetic counseling. Once 

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results return, men will be called to come in for a results disclosure visit to discuss their results 
and answer any questions.  
 
Assessment of genetic counseling experience. Since genetic testing of AA men is a novel field 
and is understudied, we will take the opportunity to survey men about their genetic counseling 
experience at the pre-test counseling visit and the post-test visit. We will use the Satisfaction with 
Genetic Counseling Scale,31 a 6-item validated measure with responses entered on a Likert scale 
ranging from “Strongly Agree” to “Strongly Disagree”. The questions include: (1) The provider 
or staff member seemed to understand the stresses I was facing; (2) The provider or staff member 
helped me to identify what I needed to know to make decisions about genetic testing; (3) I feel 
better about my health after meeting with this provider or staff member; (4) The session was about 
the right length of time I needed; (5) The provider or staff member was truly concerned about my 
well-being; and (6)  The session was valuable to me.  
 
At the post-test visit, we will also administer a survey developed regarding knowledge and 
understanding of genetic test results, which has previously been published by the study team in a 
male population undergoing genetic testing.22 This survey includes questions about the man’s 
genetic test results (“I was found to carry a genetic mutation” or “I was found to carry a variant of 
uncertain significance”), interpretation of the results (“I am at higher risk for PCA based on my 
genetic result” or “My children are recommended to be tested based upon my genetic result”), and 
sharing of genetic results with family and providers.  
 
6.1 
Specification of Safety Parameters 
6.1.1 Unanticipated Problems 
 
The research team has considerable experience in conducting behavioral interventions.  A stakeholder 
advisory board will also provide expertise and guidance to the study team.  Problems with meeting 
recruitment goals will be discussed among study team members, which include personnel from CityLife 
Neighborhood Clinic, to consider alternative approaches.  A minority-owned health communication firm 
in Philadelphia, MEE Productions, Inc., will also be assisting the study team with recruitment and 
retention. 
6.1.2 Adverse Events 
 
We expect very few, if any, adverse events to occur with this protocol.  Any psychosocial events that do 

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occur will be reviewed by the PI and addressed immediately.  Corrective actions to the protocol, if 
warranted, will also be undertaken immediately,   
6.2 
Safety Reporting  
6.2.1 Reporting to IRB 
6.2.1.1 Unanticipated Problems 
All incidents or events that meet criteria for unanticipated problems (UAPs) as defined in Section 
6.1.1 Unanticipated Problems require the creation and completion of an unanticipated problem 
report form (OHR-20).  
UAPs that pose risk to participants or others, and that are not AEs, will be submitted to the IRB 
on an OHR-20 form via the eazUP system within 10 working days of the investigator becoming 
aware of the event.  
UAPs that do not pose risk to participants or others will be submitted to the IRB at the next 
continuing review.  
6.2.1.2 Adverse Events  
Grade 1 AEs will be reported to the IRB at continuing review.  
Grade 2 AEs will be reported to the IRB at the time of continuing review.  
6.2.1.3.  Serious Adverse Events  
SAEs will be reported to the IRB on OHR-10 forms via the electronic reporting system (eSAEy) 
according to the required time frames described below. 
Grade 3-4 AEs that are unexpected and deemed to be at least possibly related to the study will be 
reported to the IRB within 2 working days of knowledge of the event. 
Grade 3-4 AEs that are deemed unrelated to the study will be reported to the IRB within 5 
working days.  
Grade 5 AEs will be reported to the IRB within one working day of knowledge of the event. 
All SAEs will be submitted to the IRB at continuing review, including those that were reported 
previously. 

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6.2.2 Reporting to SKCC DSMC 
All AEs and SAEs, safety and toxicity data, and any corrective actions will be submitted to the 
DSMC per the frequency described in the SKCC DSMP. The report to the SKCC DSMC will 
also include any unanticipated problems that in the opinion of the PI should be reported to the 
DSMC. 
 
 
Reporting to Funding Sponsor 
Any adverse events will be reported to the sponsor of the study, the Department of Defense.   
7 Study Oversight 
In addition to the PI’s responsibility for oversight, study oversight will be under the direction of 
the SKCC’s Data and Safety Monitoring Committee (DSMC). The SKCC DSMC operates in 
compliance with a Data and Safety Monitoring Plan (DSMP) that is approved by the NCI.  
8 Clinical Site Monitoring and Auditing 
Clinical site monitoring and auditing is conducted to ensure that the rights of human participants 
are protected, that the study is implemented in accordance with the protocol and/or other 
operating procedures, and that the quality and integrity of study data and data collection methods 
are maintained. Monitoring and auditing for this study will be performed in accordance with the 
SKCC’s Data and Safety Monitoring Plan (DSMP) developed by the SKCC Data and Safety 
Monitoring Committee (DSMC). The DSMP specifies the frequency of monitoring, monitoring 
procedures, the level of clinical site monitoring activities (e.g., the percentage of participant data 
to be reviewed), and the distribution of monitoring reports. Some monitoring activities may be 
performed remotely, while others will take place at the study site(s). Appropriate staff will 
conduct monitoring activities and provide reports of the findings and associated action items in 
accordance with the details described in the SKCC DSMP. 
9 Statistical Considerations  
9.1 
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Men who are educated about PCA genetic testing by peer health educators will be less conflicted 
about their decision to seek genetic testing than men who receive traditional information by mail. 
9.2 
Analysis Plans 
Decisional Conflict to Consider Genetic Testing. All study variables, such as demographics, 
PCA knowledge, and outcome responses, will be summarized in tables with descriptive statistics 
or graphically in data plots at each time they are assessed along with changes in responses over 
time. We will investigate imbalances in these data for potential confounding of primary and 
exploratory endpoint analyses and investigate disparities and intervention effect modification in 
various subgroups of subjects. The primary outcome is decisional conflict regarding genetic testing 
assessed by the 4-item SURE scale. To compute a summary decisional conflict score, the Likert-
scaled responses will be averaged across the SURE item responses provided by a subject 
completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline 
and endpoint at 2-months will be calculated and group means for these changes compared between 
subjects randomized to receive control materials vs. those randomized to receive the peer health 
education intervention (i.e., by intention to treat). The significance of the difference will be 
evaluated at the 0.05 level using a two-sided Student’s t-test. The assumptions for this test will be 
carefully evaluated. If the changes are substantially skewed, they will be summarized with group 
medians and evaluated for significant differences by the nonparametric Wilcoxon’s rank sum test. 
If concerns arise over potential confounding from imbalances in baseline covariates, we will 
conduct a sensitivity analysis by applying analysis of covariance (ANCOVA) to adjust the 
comparison for baseline imbalances, including baseline decisional conflict scores. 
 
Descriptive and Exploratory Analyses. Exploratory analyses will include estimating the 
proportion of AA men meeting the NCCN guidelines for genetic testing8,10 and computing a 95% 
confidence interval using the Clopper-Pearson exact method. Summary statistics and qualitative 
analyses will be used to assess the genetic counseling experience of those subjects accepting the 
offer for genetic counseling. Additional analyses will include estimating the intervention effect on 
genetic testing/counseling intentions and uptake, respectively, changes in attitudes toward genetic 
testing, and understanding of personal genetic test results using discrete variable tests, such as 
McNemar’s test.      
9.3 
Sample Size Considerations 
Sample Size Considerations and Missing Data Analysis. In a study conducted at Jefferson of 
273 older AA subjects at risk of PCA, the SURE decisional conflict instrument showed good 
reliability (Cronbach’s α = 0.76) and the summary scores were 3.77±0.76, on average. A sample 
size of n=75 per group (N=150 total) is necessary in order to have at least 90% power to detect a 
difference of at least 0.40 Likert scale units (a moderate, but clinically important, relative effect 
size of about ½ standard deviation) in mean decision conflict between control and intervention by 

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a two-sided t-test with a 5% type I error rate. We plan to over-recruit to 176 men (88 men per arm) 
to account for ~15% expected attrition. Missing data patterns across all efficacy outcome variables 
over time will be evaluated and multiple imputation will be considered if the data appear likely to 
be missing at random. Sensitivity to missing data mechanism assumptions will be evaluated, with 
methods such as pattern mixture modeling, if more than 10% of data are missing for any outcome 
variable.  
10 Source Documents and Access to Source Data/Documents 
Study staff will maintain appropriate medical and research records for this study, in compliance 
with ICH E6, and regulatory and institutional requirements for the protection of confidentiality 
of participant information. Study staff will permit authorized representatives of SKCC and 
regulatory agencies to examine (and when required by applicable law, to copy) research records 
for the purposes of quality assurance reviews, audits, and evaluation of the study safety, progress 
and data validity.  

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11 Quality Control and Quality Assurance 
Prior to the start of the study, a manual of operating procedures will be created to describe all study-
related tasks and procedures.  The study PI will be responsible for ensuring that all study staff are trained 
on the manual and are competent in executing study procedures.   
 
In addition to ensuring that all study staff are trained on study procedures, it is important that the 
peer health educators are familiar and competent in delivering the experimental arm of the study 
intervention.  To assess peer educator competency prior to the start of the intervention, we will 
adapt evaluation materials from the International Society of Nurses in Genetics 2011 Consensus 
Panel and survey on knowledge and understanding of PCA genetics and genetic results.22,25 
Example true/false assessment questions will include:  (1) Factors such as personal behavior (diet, 
exercise) and environmental conditions (exposures) can raise the risk of getting prostate cancer; 
(2) Men with a family history of prostate cancer should also consider other factors that could raise 
the risk of getting prostate cancer, such as diet or exposures; (3) A family history of prostate cancer 
can raise the risk of getting prostate cancer; (4) Family history of additional cancers, such as breast 
cancer, can raise the risk of getting prostate cancer; (5) Having a history of prostate cancer on his 
mother’s side of the family, can raise the risk of a man getting prostate cancer; (6) A genetic test 
can tell if someone will definitely get prostate cancer in the future; (7) Genetic testing may still be 
important even if a man has prostate cancer; (8) Patients with one cancer can be at risk for getting 
other cancers if the patient has a genetic mutation. 
 
Additional multiple-choice questions will include: (1) What types of genetic test results can you 
get from genetic testing? (2) How can genetic testing be used in treatment of prostate cancer? (3) 
How can genetic testing be used in prostate cancer screening discussions? (4)  What should a man 
know about genetic discrimination laws before proceeding with genetic testing? (5) What 
additional cancer risks might be learned from genetic testing for prostate cancer?  Peer health 
educators will be expected to score correctly on 80% or more of the questions to proceed with the 
intervention in Aim 3. Any areas of deficiency in understanding will be addressed by the study 
team in a group format or one-on-one with a peer health educator.  
 
12 Ethics/Protection of Human Participants  
12.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles set 
forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human 
Subjects of Research, as drafted by the US National Commission for the Protection of Human 

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Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 
and/or the ICH E6.  
12.2 Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form must be obtained before any participant is enrolled. Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented in the study.  
12.3 Informed Consent Process 
 
Aim 1: Informed consent will be obtained from each participant prior to the start of a focus group.  
Men will be presented an informed consent statement that details the purpose of the study and the 
roles and responsibilities of both the research team and the participant.  The moderator of the focus 
group will review the consent statement with the participants and answer any questions that may 
arise.  Participants may take as long as needed to read the statement and provide consent. 
 
Aim 2/3: A copy of the consent statement will be mailed to the participants.  Yet, a copy of the 
document will be provided to them for their records. 
 
12.4 Exclusion of Women, Minorities, and Children (Special Populations) 
Because women and children are not a risk for PCA, they will be excluded from participating in 
this study.  We expect that the majority of our participants will be African American or Hispanic 
males, due to the location of the recruiting clinical site and the nature of its surrounding 
community. 
12.5 Participant Confidentiality 
Participant confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples 
and genetic tests in addition to any study information relating to participants.  The study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party 
without prior written approval of the sponsor.  The study monitor or other authorized 
representatives of the sponsor may inspect all study documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) for the study participants. The clinical study site will permit access to such records. 

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12.6 Future Use of Stored Specimens and Other Identifiable Data  
 
All data will be de-identified for purposes of analysis.  Data may be used for additional analyses 
after the study has ended, but only de-identified data will be used for these analyses.    
13 Data Handling and Record Keeping 
The investigators are responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. All source documents must be completed in a neat, legible 
manner to ensure accurate interpretation of data. The investigators will maintain adequate case 
histories of study participants, including accurate case report forms (CRFs), and source 
documentation. 
13.1 Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff under the 
supervision of the investigator. All source documents and laboratory reports must be reviewed by 
the study team and data entry staff, who will ensure that they are accurate and complete. 
Unanticipated problems and adverse events must be reviewed by the investigator or designee.  
13.2 Data Capture Methods 
Aim 1: Focus group discussions will be audio recorded and transcribed verbatim by a 
professional transcription company.  Word document files will be returned to the study team ina  
de-identified format. 
 
Aim 2: Survey data will be collected by paper-and-pencil methods and entered into RedCap by a 
member of the study team.   
13.3 Study Records Retention 
Study records will be maintained for at least three years from the date that the grant federal 
financial report (FFR) is submitted to the Department of Defense. 
Study documents must be retained for a minimum of 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or contemplated marketing applications 
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
development of the investigational product. These documents will be retained for a longer period, 
however, if required by local regulations. No records will be destroyed without the written consent 
of the sponsor, if applicable. It is the responsibility of the sponsor to inform the investigator when 
these documents no longer need to be retained. 

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13.4 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol, Good Clinical Practice, 
or Manual of Procedures requirements. The noncompliance may be on the part of the participant, 
the investigator, or study staff. As a result of deviations, corrective actions are to be developed by 
the study staff and implemented promptly. 
All deviations from the protocol will be addressed in study participant source documents and 
promptly reported to the IRB and other regulatory bodies according to their requirements.  
14 Study Finances 
14.1 Funding Source 
 
The study is funded by the Department of Defense, Prostate Cancer Research Program. 
14.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) will have the conflict 
reviewed by a properly constituted Conflict of Interest Committee with a Committee-sanctioned 
conflict management plan that has been reviewed and approved by the study sponsor prior to 
participation in this study. All Jefferson University Investigators will follow the TJU Conflicts of 
Interest Policy for Employees (107.03). 
14.3 Participant Stipends or Payments 
Aim 1:  Participants will be compensated $25 for attending a focus group. 
Aims 2/3: Each man who participates in all study-related activities will receive $50 over the course 
of the study.  Men in the intervention group will receive $25 for completing the baseline survey at 
the time of the health education session and $25 for completing the endpoint survey over the 
telephone at two-months post-intervention. Men in the control group will receive $25 after 
completing the baseline survey and an additional $25 for completing the endpoint survey over the 
telephone at two-months post-intervention.   
 
15 Publication and Data Sharing Policy 

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The International Committee of Medical Journal Editors (ICMJE) member journals have adopted 
a clinical trials registration policy as a condition for publication. The ICMJE defines a clinical 
trial as any research project that prospectively assigns human participants to intervention or 
concurrent comparison or control groups to study the cause-and-effect relationship between a 
medical intervention and a health outcome. Medical interventions include drugs, surgical 
procedures, devices, behavioral treatments, process-of-care changes, and the like. Health 
outcomes include any biomedical or health-related measures obtained in patients or participants, 
including pharmacokinetic measures and adverse events. The ICMJE policy requires that all 
clinical trials be registered in a public trials registry such as ClinicalTrials.gov, which is 
sponsored by the National Library of Medicine. Other biomedical journals are considering 
adopting similar policies. The ICMJE does not review specific studies to determine whether 
registration is necessary; instead, the committee recommends that researchers who have 
questions about the need to register err on the side of registration or consult the editorial office of 
the journal in which they wish to publish. 
16 Literature References 
 
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Available at: www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-
statistics/annual-cancer-facts-and-figures/2018/cancer-facts-and-figures-2018.pdf  
2. National Institutes of Health News Release: NIH and Prostate Cancer Foundation launch large 
study on aggressive prostate cancer in African-American men. Release date July 17, 2018. 
Available at: www.nih.gov/news-events/news-releases/nih-prostate-cancer-foundation-launch-
large-study-aggressive-prostate-cancer-african-american-men 
3. Pritchard CC, Mateo J, Walsh MF, et al. Inherited DNA-Repair Gene Mutations in Men with 
Metastatic prostate cancer. N Engl J Med 375:443-453, 2016. 
4. Schrader KA, Cheng DT, Joseph V, et al. Germline Variants in Targeted Tumor Sequencing 
Using Matched Normal DNA. JAMA Oncol 2(1):104-11, 2016. 
5. Giri VN, Obeid E, Gross L, et al. Inherited Mutations in Males Undergoing Multigene Panel 
Testing for Prostate Cancer – Emerging Implications for Personalized Prostate Cancer Genetic 
Evaluation. Journal of Clinical Oncology – Precision Oncology 2017. DOI: 
10.1200/PO.16.00039. 

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6. Mateo J, Carreira S, Sandhu S, et al. DNA-repair defects and olaparib in metastatic prostate 
cancer. N Engl J Med 373(18): 1697-708, 2015. 
7. Giri VN, Knudsen KE, Kelly WK, et al. Role of genetic testing for inherited prostate cancer 
risk: Philadelphia Prostate Consensus Conference 2017. J Clin Oncol 2018;36:414-24. 
8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Prostate (Version 
4.2018). (Accessed August 23, 2018, at:  
https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf ) 
9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Prostate Cancer Early 
Detection (Version 1.2018). [Accessed April 29, 2018]. Available at: 
https://www.nccn.org/professionals/physician_gls/PDF/prostate_detection.pdf  
10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): Genetic/Familial 
High-risk Assessment: Breast and Ovarian (Version 2.2019). (Accessed August 13, 2018, at 
https://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf.) 
11. Hann KEJ, Freeman M, Fraser L, et al. Awareness, knowledge, perceptions, and attitudes 
towards genetic testing for cancer risk among ethnic minority groups: a systematic review. BMC 
Public Health. 2017;17:503. doi:10.1186/s12889-017-4375-8. 
12. Pennsylvania Department of Health.  Pennsylvania Cancer Incidence and Mortality, 2015.  
Division of Health Informatics, Pennsylvania Cancer Registry, Pennsylvania Cancer Control 
Program.    Harrisburg, Pennsylvania: 2018.  Accessible at: 
https://www.health.pa.gov/topics/HealthStatistics/CancerStatistics/AnnualCancerReport/Pages/A
nnualCancerReport.aspx 
13. J.M. Simoni, J.C. Franks, K. Lehavot, S.S. Yard.  Peer interventions to promote health: 
Conceptual considerations.  Am. J. Orthopsychiatry 2011;81(3): 351-359. 
14. Z.A. Bhutta, J.K. Das, A. Rizvi, M.F. Gaffey, N. Walker, S. Horton, et al.  Evidence-based 
interventions for improvement of maternal and child nutrition: what can be done and at what 
cost?  Lancet 2013; 382 (9890): 452-477. 
15. C.S. Fabrizio, M. Liere, G. Pelto.  Identifying determinants of effective complementary 
feeding behaviour change interventions in developing countries.  Matern. Child Nutr 2014; 
10(4): 575-592. 

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16. W. Affleck, G. Pelto.  Caregivers' responses to an intervention to improve young child 
feeding behaviors in rural Bangladesh: a mixed method study of the facilitators and barriers to 
change.  Soc. Sci. Med 2012; 75(4): 651-658. 
17. J. Cordero Coma.  HIV prevention and marriage: peer group effects on condom use 
acceptability in rural Kenya.  Soc. Sci. Med 2014; 116:169-177. 
18. Ramchand R, Ahluwalia SC, Xenakis L, Apaydin E, Raaen L, Grimm G.  A systematic 
review of peer-supported interventions for health promotion and disease prevention.  Prev Med 
2017; 101:156-170.  
19. Alford SH, McBride CM, Reid RJ, Larson EB, Baxevanis AD, Brody LC.  Participation in 
genetic testing research varies by social group.  Public Health Genomics 2011; 14(2): 85-93. 
20. Joseph G, Pasick RJ, Schillinger D, Luce J, Guerra C, Cheng J.  Information mismatch: 
Cancer risk counseling with diverse underserved patients.  J Genet Counsel 2017; 26(5): 1090-
1104. 
21. Giri VN, Gross L, Gomella LG, and Hyatt C. How I Do It: Genetic Counseling and Genetic 
Testing for Inherited Prostate Cancer. Can J Urol 2016 Apr;23(2):8247-53. 
22. Giri VN, Obeid E, Hegarty SE, Gross L, Bealin L, Hyatt C, Fang CY, PhD, and Leader A. 
Understanding of Multigene Test Results Among Males Undergoing Germline Testing for 
Inherited Prostate Cancer: Implications for Genetic Counseling. Prostate. 2018 Apr 14. doi: 
10.1002/pros.23535. 
23. Ryan G, Bernard HR: Techniques to identify themes. Field Methods 2003, 15(1):85-109. 
24. Genetics Toolkit: American Society of Clinical Oncology. Available at: 
www.asco.org/practice-guidelines/cancer-care-initiatives/genetics-toolkit  
25. Jenkins J. Essential Genetic and Genomic Nursing Competencies for the Oncology 
Nurse. Seminars in oncology nursing. 2011;27(1):64-71. doi:10.1016/j.soncn.2010.11.008. 
26. Ferron Parayre A, Labrecque M, Rousseau M, Turcotte S, Légaré F. Validation of SURE, a 
Four-Item Clinical Checklist for Detecting Decisional Conflict in Patients. Med Decis Making. 
2014 Jan;34(1):54-62. doi: 10.1177/0272989X13491463. Epub 2013 Jun 17. 

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27. Pasick RJ, Joseph G, Stewart S, Kaplan C, Lee R, Luce J, Davis S, Marquez T, Nguyen T, 
Guerra C.  Effective Referral of Low-Income Women at Risk for Hereditary Breast and Ovarian 
Cancer to Genetic Counseling: A Randomized Delayed Intervention Control Trial.  Am J Public 
Health 2016;106(10):1842-8. 
28. Riley BD, Culver JO, Skrzynia C, et al. Essential elements of genetic cancer risk assessment, 
counseling, and testing: updated recommendations of the National Society of Genetic 
Counselors. J Genet Couns. 2012 Apr;21(2):151-61. 
29. Institute of Medicine (US) Committee on Assessing Genetic Risks; Andrews LB, Fullarton 
JE, Holtzman NA, et al., editors. Assessing Genetic Risks: Implications for Health and Social 
Policy. Washington (DC): National Academies Press (US); 1994. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK236044/ 
30. Richards S, Aziz N, Bale S, Bick D, Das S, Gastier-Foster J, Grody WW, Hegde M, Lyon E, 
Spector E, Voelkerding K, Rehm HL; ACMG Laboratory Quality Assurance Committee. 
Standards and guidelines for the interpretation of sequence variants: a joint consensus 
recommendation of the American College of Medical Genetics and Genomics and the 
Association for Molecular Pathology. Genet Med. 2015 May;17(5):405-24. 
31. Schwartz MD, Valdimarsdottir HB, Peshkin BN, et al. Randomized noninferiority trial of 
telephone vs. in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol 
32:618-626, 2014. 
 
Appendices 
 
Study materials (surveys, consent forms, educational brochures, and recruitment materials) will 
be created by the study team upon the receipt of study funds and will be amended to this protocol 
as they become available.