Increasing African Immigrant's Breast Cancer Screening
Phase: NA
Conditions: Breast Cancer
Sponsor: Icahn School of Medicine at Mount Sinai

Increasing African Immigrant's Breast Cancer Screening 
PI: Jamilia R. Sly, PhD
NCT04450264
Document Date: 1/26/2024

Increasing African Immigrants’ Breast Cancer Screening
Protocol Number*: STUDY-19-00114
National Clinical Trial (NCT) Identified Number: NCT04450264
Principal Investigator*: Jamilia R. Sly, PhD
Sponsor: Icahn School of Medicine at Mount Sinai
Grant Title: Increasing African Immigrants’ Breast Cancer Screening
Grant Number*: R21MD012863
Funded by: National Institute for Minority Health and Health Disparities
Version Number:  v. 1.3
17 March 2023
Effective Date: 1/26/2024
End Date:1/25/2025

Based on “NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans”
CONFIDENTIALITY STATEMENT
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the 
NIH terms of award. 
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Table of Contents
STATEMENT OF COMPLIANCE.......................................................................................................................................1
INVESTIGATOR’S SIGNATURE ........................................................................................................................................2
1
PROTOCOL SUMMARY......................................................................................................................................3
1.1
Synopsis..................................................................................................................................................3
1.2
Schema ..................................................................................................................................................4
1.3
Schedule of Activities .............................................................................................................................5
2
INTRODUCTION.................................................................................................................................................6
2.1
Study Rationale ......................................................................................................................................6
2.2
Background ............................................................................................................................................7
2.3
Risk/Benefit Assessment........................................................................................................................8
2.3.1
Known Potential Risks ........................................................................................................8
2.3.2
Known Potential Benefits ...................................................................................................8
2.3.3
Assessment of Potential Risks and Benefits .......................................................................8
3
OBJECTIVES AND ENDPOINTS ...........................................................................................................................9
4
STUDY DESIGN ................................................................................................................................................10
4.1
Overall Design ......................................................................................................................................10
4.2
Scientific Rationale for Study Design....................................................................................................11
4.3
Justification for Intervention................................................................................................................12
4.4
End-of-Study Definition........................................................................................................................13
5
STUDY POPULATION .......................................................................................................................................13
5.1
Inclusion Criteria ..................................................................................................................................13
5.2
Exclusion Criteria..................................................................................................................................13
5.3
Lifestyle Considerations .......................................................................................................................13
5.4
Screen Failures .....................................................................................................................................14
5.5
Strategies for Recruitment and Retention ...........................................................................................14
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)..................................................................15
6.1
Study Intervention Administration.......................................................................................................15
6.1.1
Study Intervention Description.........................................................................................15
6.1.2
Administration and/or Dosing ..........................................................................................16
6.2
Fidelity..................................................................................................................................................16
6.2.1
Interventionist Training and Tracking...............................................................................16
6.3
Measures to Minimize Bias: Randomization and Blinding ...................................................................16
6.4
Study Intervention/Experimental Manipulation Adherence................................................................16
6.5
Concomitant Therapy...........................................................................................................................16
6.5.1
Rescue Therapy ................................................................................................................17
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL.............................................................................................................................17
7.1
Discontinuation of Study Intervention/Experimental Manipulation....................................................17
7.2
Participant Discontinuation/Withdrawal from the Study ....................................................................17
7.3
Lost to Follow-Up .................................................................................................................................17
8
STUDY ASSESSMENTS AND PROCEDURES.......................................................................................................18
8.1
Endpoint and Other Non-Safety Assessments .....................................................................................18
8.2
Safety Assessments..............................................................................................................................19
8.3
Adverse Events and Serious Adverse Events........................................................................................19
8.4
Unanticipated Problems.......................................................................................................................19
8.4.1
Definition of Unanticipated Problems..............................................................................19
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8.4.2
Unanticipated Problems Reporting ..................................................................................20
8.4.3
Reporting Unanticipated Problems to Participants..........................................................21
9
STATISTICAL CONSIDERATIONS.......................................................................................................................21
9.1
Statistical Hypotheses ..........................................................................................................................21
9.2
Sample Size Determination..................................................................................................................21
9.3
Populations for Analyses......................................................................................................................21
9.4
Statistical Analyses...............................................................................................................................22
9.4.1
General Approach.............................................................................................................22
9.4.2
Analysis of the Primary and secondary Endpoint(s) .........................................................22
9.4.3
Safety Analyses.................................................................................................................23
9.4.4
Baseline Descriptive Statistics ..........................................................................................23
9.4.5
Planned Interim Analyses .................................................................................................23
9.4.6
Sub-Group Analyses..........................................................................................................23
9.4.7
Tabulation of Individual Participant Data.........................................................................24
9.4.8
Exploratory Analyses ........................................................................................................24
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS. .....................................................24
10.1
Regulatory, Ethical, and Study Oversight Considerations ....................................................................24
10.1.1
Informed Consent Process................................................................................................24
10.1.2
Study Discontinuation and Closure...................................................................................25
10.1.3
Confidentiality and Privacy...............................................................................................25
10.1.4
Future Use of Stored Specimens and Data.......................................................................26
10.1.5
Key Roles and Study GovernancE .....................................................................................26
10.1.6
Safety Oversight................................................................................................................26
10.1.7
Clinical Monitoring ...........................................................................................................26
10.1.8
Quality Assurance and Quality Control.............................................................................26
10.1.9
Data Handling and Record Keeping ..................................................................................27
10.1.10
Conflict of Interest Policy..................................................................................................28
10.2
Additional Considerations....................................................................................................................29
10.3
Abbreviations and Special Terms .........................................................................................................29
10.4
Protocol Amendment History ..............................................................................................................31
11
REFERENCES....................................................................................................................................................32
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STATEMENT OF COMPLIANCE
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and the following: 
•
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812). 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for 
the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training.
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(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form.
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INVESTIGATOR’S SIGNATURE
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study 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, as described in the Statement of Compliance above.
Principal Investigator or Clinical Site Investigator:
Signed:
Date:
03/9/2023
Name*: Jamilia Sly, PhD
Title*: Assistant Professor
Investigator Contact Information
Affiliation*: Icahn School of Medicine at Mount Sinai
Address: One Gustave L Levy Place, Box 1077
Telephone: 212-824-7813
Email: Jamilia.sly@mssm.edu 
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1
PROTOCOL SUMMARY
1.1
SYNOPSIS 
Title:
Increasing African Immigrants’ Breast Cancer Screening
Grant Number:
R21MN012863
Study Description:
The barriers and facilitators to breast cancer screening for other minority groups 
from underserved populations, such as African Americans and Latina women 
have been studied. Less is known about these for African immigrant women and 
how to most effectively engage their participation in regular screening. The long 
term goal of the proposed project is to conduct a clinical trial that tests the 
feasibility of an adapted intervention to increase breast cancer screening rates 
for African-born immigrants. The study team plans to pursue the following 
specific aims: (1) Identify barriers and facilitators to breast cancer screening 
among African-born immigrants and (2) Culturally adapt and pilot test the 
Witness Project breast cancer education program for African-born women. 
Objectives*:
Primary Objective: Adapt and pilot the Witness Project breast cancer education 
program. Secondary Objectives: Identify barriers and facilitators of breast cancer 
screening 
Endpoints*:
Primary Endpoint: change from baseline assessment of mammogram screening 
intention and mammogram location and appointment.
Secondary Endpoints: change from baseline assessment of perceived breast 
cancer risk and self-efficacy for mammography.
Study Population:
Men or women 18 and older; stakeholder or leader in African immigrant 
community; English or French speaking (Aim 1) 
African-born women 40 years and older; English or French speaking (Aim 1) 
African-born women 38 years and older; English or French speaking (Aim 2) 
Phase* or Stage:
Not Applicable
Description of 
Sites/Facilities 
Enrolling 
Participants:
Participants will be enrolled at one site (Icahn School of Medicine at Mount Sinai) 
in collaboration with African immigrant-serving community organizations. 
Description of 
Study 
Intervention/Exper
imental 
Manipulation:
African immigrant women are at significant risk for not participating in preventive 
screening, such as for breast cancer. Thus, this project will culturally adapt an 
existing evidenced-based intervention, the Witness Project, by identifying 
barriers and facilitators to screening for African-born women and, guided by the 
Health Belief Model, incorporate those findings into a group-based narrative 
education program for English and French-speaking African immigrant women. 
The program content will include: (1) information about the benefits of early 
detection of breast cancer screening, (2) education about disparities in breast 
cancer, (3) education about disparities in breast cancer screening among African 
immigrant women, and (4) will address the unique barriers and facilitators of 
African immigrant women identified in Aim 1 of this study. 
Study Duration*:
18 months
Participant 
Duration:
60 min (Aim1); 90 mins (Aim 2) 
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1.2
SCHEMA 
Pre-Intervention 
Assessment

Pre-screen potential participants by inclusion and exclusion criteria;

Schedule in-depth interview or survey
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Aim 1
Aim 2
Conduct informed consent process
Administer the adapted version of the Witness Project (N=64)
Final Assessments

Perform baseline assessments using demographic questionnaires(N=80);

Administer in-depth interview (N=20 with women; N=10 with community 
leaders) or survey (N= 50 with women)
Culturally adapt the Witness Project cancer education program
for African-born immigrant women
Post-Intervention assessments
Pre-Intervention assessments
Conduct informed consent process
Pre-screen potential participants by inclusion and exclusion criteria
Data Analysis
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1.3
SCHEDULE OF ACTIVITIES 
 Pre-consent
Time 1
AIM 1
Review Eligibility
X
Schedule in-depth interview or survey
X
Informed Consent
X
Demographics
X
In-Depth Interview/Survey
X
Data Analysis
AIM 2
Cultural adaptation of the Witness Project cancer education program for African-born immigrant 
women
X
N/A
Pre-screening of potential participants by inclusion and exclusion criteria
X
N/A
Informed Consent
N/A
X
Pre-Intervention assessments
N/A
X
Administration of the adapted version of the Witness Project
N/A
X
Post-Intervention assessments
N/A
X
Outcome Evaluation
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2
INTRODUCTION
2.1
STUDY RATIONALE 
New York City (NYC) is home to a large and diverse immigrant population. Specifically, African immigration 
has increased over 750% in the past 20 years with a high concentration living in NYC.1,2 African immigrants 
are a very heterogeneous population with no individual country accounting for more than 14% of the 
total; most are likely to live below the poverty line, less likely to have health insurance, more likely to have 
low health literacy, and less likely to visit a doctor particularly for primary/preventive care.3,4,5 While 
overall screening rates for breast cancer have increased significantly in NYC in the last decade6,7, many 
immigrant groups still face significant barriers to preventive health care, including lack of insurance, poor 
health care access and language difficulties. Without access to primary care, many preventive services, 
like breast cancer screening, go unattended. For example, annual mammography exams and timely 
follow-ups after abnormal findings are crucial for the early detection of breast cancer, which has been 
shown to be one of the most important factors of increased survival. 
Health disparities plague the health care system and arise from a complex interplay of economic, social 
and cultural factors. The Health Belief Model (HBM) provides a framework for addressing cultural health 
disparities related to preventive health care and cancer screening by positing that making a decision to 
engage in a health behavior (e.g., cancer screening) is determined by weighing perceived threats 
(susceptibility, barriers) versus benefits.11 Traditionally, health information has been presented in didactic 
forms (i.e., statistical evidence/facts) to educate, persuade, and engage target communities.12,13 Narrative 
communication (i.e., storytelling, personal testimonials) has emerged as a method for supporting and 
motivating behavioral change including personal experiences with cancer or screening. The appeal and 
success of narrative communication stem from its familiarity as a basic mode of human interaction.14,15 
Our own work in minority and immigrant communities has shown that narrative communication can 
increase participation in cancer screening. Thus group-based narrative educational programs could play a 
significant role in promoting healthy preventive engagement including breast cancer screening among 
African immigrants.16,17,18,19 
The proposed project is innovative in several important ways. First, to our knowledge, this study is the 
first to examine barriers and facilitators regarding the uptake of breast cancer screenings among eligible 
African-born women immigrants in NYC. A community-based intervention is one that entails a strategy 
for education and behavior change by increasing awareness and knowledge through public service 
announcements, education, written manuals, etc. Research on breast and cervical cancer screenings has 
targeted African Americans and Latinas 20,4,21,22,23; but few have targeted African-born populations. 
Second, a community-based recruitment strategy for the cancer screening education intervention is 
proposed. Adopting this approach will allow us to reach African-born immigrant women at places they 
frequent and provide new information about the barriers and facilitators to breast cancer screenings, 
particularly among those who are currently unable to access health care. Third, to our knowledge, this is 
the first study to obtain the perspectives of African-born community leaders about how African immigrant 
women’s participation in breast cancer screening can be improved. Fourth, this project will represent the 
first approach to pilot test the feasibility and acceptability of a narrative approach in educating African-
born immigrants about breast cancer screening. While education programs can improve cancer and 
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cancer screening knowledge20,24 and increase intent to get screened for other underserved populations, 
it remains to be seen if a theory-informed and evidence-based education program can be similarly 
effective among African-born immigrants. By incorporating an understanding of the barriers and 
facilitators to breast cancer screenings, we will target important facilitators and potential barriers to 
address in future interventions.  
The long term goal of the proposed project is to conduct a randomized clinical trial that tests the adapted 
intervention to increase breast cancer screening rates for African-born immigrants. In the short term, we 
plan to pursue the following specific aims: (1) Identify barriers and facilitators to breast cancer screening 
among African-born immigrants and (2) Culturally adapt and pilot test the Witness Project breast cancer 
education program for African-born women. Thus, we will culturally adapt an effective, innovative 
intervention to address this significant health disparity in African-born immigrant communities. Once we 
have pilot tested the feasibility and acceptability of the intervention, we will apply for R01 funding.
2.2
BACKGROUND 
Minimal research has been conducted specifically on the needs of African immigrant groups. Though 
African immigrants and African Americans/blacks share a common ancestral history, they are distinct 
cultural groups with differing values, perceptions, experiences and languages.8 Available research studies 
often erroneously classify each culture as one homogenous group (i.e., African American/Black), which 
limits our understanding of the specific needs of African immigrants. Most research on the cancer control 
needs of African immigrants has focused on individuals from Nigeria, Somalia and Ghana9, furthering 
limiting our understanding of individuals who are not from these countries. Immigrants from Africa come 
from many different countries that have distinct languages.10 Lack of knowledge of the US healthcare 
system is a persistent problem for African immigrants and addressing language access and health literacy 
may be one approach to improving healthcare engagement in this population.
Our breast cancer screening data in this population of African-born immigrants, when corrected for age, 
shows that only 56% have ever had a mammography for breast cancer screening. This finding 
demonstrates the need for breast cancer screening awareness and education within this population. We 
have conducted robust culturally targeted outreach into several minority communities. The Witness 
Project (WP) is a community-based cervical and breast cancer education program that is designed to meet 
educational and cultural levels of underserved African American women. The WP model is a belief and 
theory-based intervention incorporating the Health Belief Model, locus of control beliefs, social learning 
theory, transtheoretical model of change and the 4MAT System.43 The program begins with a narrative 
presentation by a breast cancer survivor who briefly shares her personal experience of breast cancer, from 
diagnosis to treatment and survivorship. Lay volunteers present educational information about breast 
cancer risks and protective factors, demonstrate how to perform a breast self-examination and a question 
and answer session concludes the program. Research by Jandorf (Co-I) and Erwin successfully replicated 
the Witness Project in 22 states at 40 unique sites including NYC. Replication was achieved using an 
Implementation Guide, locally produced, award winning video (now on CancerControl PLANET RTIPs) and 
training curriculum developed by Erwin and Jandorf (National Cancer Institute Cancer Control Planet). In 
NYC, we conducted hundreds of programs at a variety of community sites and have educated over 3,000 
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participants.44,20,45,12 This research demonstrates our ability to reach culturally targeted members in the 
community and over 15 years of community-based research experience. 
Development of Esperanza y Vida: A unique aspect of the Witness Project is the ability to adapt the 
program to another culture as evidenced by Esperanza y Vida (EyV). In 2003, Jandorf and colleagues 
initiated EyV to expand this breast educational program among Hispanic populations in a culturally and 
linguistically congruent, community-based approach.4,12 EyV development was conducted with members 
of the target group, including qualitative studies, to ensure the adaptation would be culturally appropriate 
and meaningful.46,47 The social network characteristics and language preferences (Spanish) assessed and 
integrated into the intervention to include such factors of where to present the programs (e.g. both 
community and faith-based locations) and the need to educate men about issues related to women’s 
health.22,4 This successful replication and adaptation demonstrates our ability to adapt education 
programs through vigorous qualitative methods and pilot testing as well as to address linguistic needs of 
different cultural groups.
2.3
RISK/BENEFIT ASSESSMENT 
2.3.1
KNOWN POTENTIAL RISKS 
Physical risks in this study are minimal. The surveys include questions that are not different from those 
that might be asked or presented by a health care provider and thus do not pose greater than minimal 
risk. Although the chances of psychological distress are minimal, any psychological distress will be 
monitored by the staff and reported to the Principal Investigator.
2.3.2
KNOWN POTENTIAL BENEFITS
Although we cannot guarantee that participants may benefit directly from study participation, prior study 
participants have reported that they enjoyed providing researchers with greater knowledge of their 
experience in hopes of aiding the design of cancer prevention programs and materials and in possibly 
benefiting others. It is possible that for patients, participating may raise awareness of their need to uptake 
cancer screening and their decision to undergo screening. There are minimal physical risks posed by this 
study. Risk of psychological distress is possible as a reaction to some study questions about cancer. 
Research staff will monitor participants’ reactions. Through the ongoing monitoring process of the study 
(e.g., regular meetings with research staff), the PI will be informed of any concerns/distress that occur at 
any point in the study. Given the potential gains to participants, the ratio of risk to benefits is quite low 
and reasonable.  
2.3.3
ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
The knowledge gained by conducting this research will help us to potentially develop interventions to 
increase the uptake of breast cancer screening among African-born immigrant women at high risk for 
breast cancer. There is minimal physical risk and minimal risk of psychological distress as a reaction to 
some study questions about cancer and screening; however these risks are overpowered by the 
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potentially life-saving benefits of cancer screening to prevent the onset of breast cancer in African born 
immigrant women.
Given the potential gains to participants, the ratio of risk to benefits is quite low and reasonable. There 
are no effective alternative procedures for collecting these data
3
OBJECTIVES AND ENDPOINTS 
OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
Primary
Adapt and pilot the 
Witness Project 
breast cancer 
education program
Primary Outcome Measure:
1.
Mammogram intention:
Participants' intentions to complete breast cancer 
screening by responding to:
A. For women who had a mammogram in 
the past: Do you think you will have 
another one?
Yes, later this year (2023)
Yes, next year (2024)
Yes, in two years (2025)
No
Not sure/don’t know
B.
For women who never had a 
mammogram in the past: Do you think 
you will have one?
Yes, later this year (2023)
Yes, next year (2024)
Yes, in two years (2025)
No
Not sure/don’t know
2.
Mammogram location and appointment:
Do you know where you could go to get a 
mammogram?
Yes
No
Not sure
Secondary Outcome Measures:
3.
Perceived Risk:
Participants' perceived risk of developing breast 
cancer: What do you think are the chances that 
you will have breast cancer at some point in your 
life? (1. Very low 2. Somewhat low 3. Moderate 
Intention to screen is 
hypothesized to be a 
dependent variable. 
Perceived risk is 
hypothesized to be 
mediator variable that 
could explain the causal 
mechanisms of the 
intervention.   
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OBJECTIVES
ENDPOINTS
JUSTIFICATION FOR 
ENDPOINTS
4. Somewhat high 5. Very high) [Time Frame: 
Immediate]
4.
Comparison Perceived Risk:
Participants' perceived risk of developing breast 
cancer: Compared to the average person your 
age and gender, would you say that you are (1. 
Less likely to get breast cancer 2. About as likely 
to get breast cancer 3. More likely) to get breast 
cancer [Time Frame: Immediate]
5.
Self-Efficacy for Mammography:
Ten items will be used to examine participants' 
self-efficacy for undergoing mammography using 
a 5-point Likert-type scale. (Full scale from 1 to 5, 
with higher score indicating greater self-efficacy) 
[Time Frame: Immediate]
Self efficacy is 
hypothesized to be a 
mediator variable that 
could explain the causal 
mechanisms of the 
intervention. 
Secondary
Identify barriers and 
facilitators of breast 
cancer screening
N/A - survey/interview completion
N/A
Tertiary/Exploratory 
N/A
N/A
N/A
4
STUDY DESIGN
4.1
OVERALL DESIGN
The goal of Aim 1 is to collect formative data via a mixed methods approach and use those results to 
culturally adapt the Witness Project for African immigrant populations. Cultural adaptation will follow the 
stage model outlined by Barrera et al.48 The model includes five stages: 1) information gathering to 
determine which intervention components to modify; 2) preliminary adaptation design that integrates 
information from stage 1 to inform preliminary modification of the original intervention; 3) preliminary 
adaptation tests to pilot the intervention for feasibility and acceptability, 4) adaptation refinement with 
decisions informed a leadership team/advisory board; and 5) cultural adaptation trial to test the 
effectiveness of the intervention in changing health outcomes.  As this is the first step in this line of 
research, the proposed study will only follow stages 1-4.
The Witness Project has three main components that will be culturally adapted: 1) educational 
presentation addressing myths, barriers and values related to breast cancer and mammography, 2) 
culturally matched, peer led narrative about breast cancer experience, 3) experiential education about 
breast anatomy and self-examination.
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The “point of interface” (i.e., merging quantitative and qualitative data) will be associations between 
mammography screening and HBM constructs (e.g., perceived risk, self-efficacy) and any socio-
demographic characteristics (i.e., preferred language, health literacy level). The quantitative results will 
inform the refinement of the qualitative questions. For example, if an association is found between self-
efficacy and screening, we will ask in-depth questions about self-efficacy and suggestions for how it could 
be improved in this population.
The design chosen for the pilot-test is a one-group pretest –posttest. All of the enrolled participants will 
receive the same intervention in their preferred language (English or French). To measure the impact of 
the intervention, will conduct a pre-post assessment of key variables around perceived risk for breast 
cancer, the intention to complete a mammogram, and self-efficacy related to seeking and completing 
breast cancer screening. This trial will also assess the feasibility and acceptability of the intervention.
4.2
SCIENTIFIC RATIONALE FOR STUDY DESIGN
Aim 1. Although there are multiple social/environmental determinants of cancer screening, screening 
involves an individual deciding whether to engage in the screening behavior or not.26,27 The HBM asserts 
that an individual’s attitudes and beliefs (e.g., perceived benefits, perceived barriers) will determine their 
behavioral intentions.11 Therefore, improving breast cancer screening rates in African-born immigrant 
women requires a deep understanding of the factors that influence decisions about breast cancer 
screening uptake. Most existing health decision-making models assume that decisions about a behavior 
are a function of an individual’s perceptions of the expected utility (benefit-cost ratio) of the behavior and 
of other cognitive factors (e.g., self-efficacy, perceived risk).28,29,30 Expected utility and other cognitive 
constructs have been shown to predict engagement in cancer screening behaviors.31,32,33,34  Specifically, 
several of our own studies in colorectal cancer screening have provided data on attitudes and barriers 
regarding colorectal cancer screening including fear, fatalism, less perceived disease risk, medical 
mistrust, lack of knowledge and insurance access.35,36,37,38,39,40,41 Importantly, many existing screening 
educational interventions are based on these cognitively-focused models.62 However, to our 
understanding, there are sparse data on attitudes and beliefs regarding breast cancer screening tests 
among African-born immigrants. To our knowledge, only one intervention to improve breast cancer 
among African immigrant women has been published. A linguistically targeted DVD-based intervention 
that provided information about health care services related to mammography, pap smears, and mental 
health services to Somali and Congolese women and increased knowledge and intent to undertake 
screening.42 Culturally specific barriers and facilitators were not addressed which could have more a 
beneficial impact on intention than presenting information to participants in their language.
Aim 2. Narrative communication methods are a widely recognized tool for mitigating barriers and 
effectively increasing a variety of health behaviors including cancer screening.14,53 Transporting narratives, 
or immersion into a story, can successfully change beliefs and motivate action.15 Narrative communication 
is a comfortable way of presenting information because people communicate with each other and learn 
in everyday life primarily through stories.14 By creating a feeling of similarity to and identification with the 
communicator, narrative communication can increase an individual’s perceived risk regarding a particular 
health related behavior.54 People with personal experiences make credible, believable messengers. 
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Additionally, narratives can be particularly useful for conveying cancer information because they reduce 
counterarguments which can help individuals overcome barriers to seeking treatment.15 Narratives also 
diminish negative feelings towards unknown, difficult, or frightening procedures (e.g., screening), provide 
role models for behavior change and create new attitudes that are based on cognition and emotion.15 
Four distinct capabilities of narrative health communication are: “overcoming resistance, facilitating 
information processing, providing surrogate social connections, and representing emotional and 
existential issues.”14 Narrative means of communication have been shown to lead to significant emotional 
responses55,56 which subsequently have a large impact on behavioral decisions. This feature is a major 
strength of the narrative approach.14 Additionally, people are more likely to remember information that 
has an emotional impact on them or elicits an emotional response.57 Embedding important information 
into personal stories accomplish this more effectively than simply conveying facts.55,56 
There is substantial evidence that community-based group narrative education cancer screening 
programs can be effective in fostering positive health behavior change.53,58,24,59 However, to our 
knowledge, no studies have examined the influence of these programs on barriers and facilitators on 
health care engagement among African-born immigrants. It is anticipated that, like with other cancer 
screenings, African-born immigrants’ eligible for screenings face unique barriers to these procedures that 
can be successfully targeted in community-based group narrative education cancer screening 
interventions. One study showed that narrative communications about certain cancers (e.g., breast 
cancer) reduced message counterarguments, increased positive affect, fostered identification with the 
communicator and led to better engagement with the message. These outcomes thereby reduced 
perceived barriers, increased message recall and promoted discussion with family members.53 Another 
study examining the effect of narrative and non-narrative skin cancer messages found that participants 
exposed to the narrative message were two to four times more likely to engage in health promoting 
actions and information-seeking behavior.19 Furthermore, Dillard et al. found that participants who 
received a narrative message reported that colorectal cancer screening barriers would not have as much 
of an impact on screening decisions and the narrative message increased interest in colorectal cancer 
screening.17 While numerous studies have illustrated the success of narrative communication over 
didactic communication in terms of various types of behavior change, neither narrative or didactic 
education formats have been developed within the context of African-born immigrants.
4.3
JUSTIFICATION FOR INTERVENTION
We have described the scientific premise and discussed the strengths of weaknesses of both the published 
research and our preliminary data. This careful consideration of the prior research and our preliminary 
data has been critical in: 1) identifying the gaps apparent in research and public health practice with 
respect to the unknown barriers and facilitators that African immigrant women face when attempting to 
undergo breast cancer screening; and 2) adaptation of the narrative group-based cancer screening 
education program that we propose to pilot test. We will identify cultural barriers and facilitators to 
engagement in breast cancer screening and develop a culturally targeted breast cancer education 
program for African immigrant women. The community-based education program will be the first its kind 
to specifically target barriers and reinforce facilitators to breast cancer screening faced by African-born 
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immigrant women. Aim 1 results will also provide information about specific intervention components to 
refine and adapt our existing community based narrative group education cancer screening programs on 
breast cancer. Results will detail the specific needs of the target population to inform the execution of 
Aim 2.
The results of this proposal are in direct alignment with the objectives of PA-17-043 and will lead to the 
development of a culturally-targeted theory-informed, group-based breast cancer screening education 
program. The successful completion of the study aims will make a novel and transformative contribution 
to the field of cancer screening, especially for this underserved and understudied population.
The mode of delivery of the intervention (a culturally-adapted education program on breast cancer 
screening) will be determined together with the target population and key informants form the 
community. Aim 1 of the study is precisely oriented to gathering relevant information to inform the 
adaptation of an existing program (Witness Project). Participants in Aim 1 of the study will be asked to 
suggest the ideal length of the intervention and the frequency of intervention contacts. 
The intervention will be adapted for women born in Africa who currently live in New York City. The 
research team will explore the needs for a cultural adaptation of the existing intervention with the 
participants in Aim 1 of the study. The results of Aim 1 will inform the justification for the cultural 
adaptation.
4.4
END-OF-STUDY DEFINITION
A participant is considered to have completed the study if he or she has completed an interview or survey 
in Aim 1, or a baseline pre-program assessment and the post-program assessment in Aim 2.
The end of the study is defined as completion of the post program assessment shown in the Schedule of 
Activities (SoA), Section 1.3.
5
STUDY POPULATION
5.1
INCLUSION CRITERIA

Eligibility criteria for Aim 1 include (n=80):
i.
Eligible individuals for Aim 1 in-depth interviews with leaders (N=10) will be:
1)
18 years or older;
2)
stakeholder/gatekeeper in the African immigrant community;
3)
speak English or French. 
ii.
Eligible individuals (n=70) for Aim 1 In-depth Interviews and Quantitative Surveys will be:
1)
women who are 40 years or older;
2)
have been born in Africa;
3)
speak English or French.
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
Eligibility criteria for Aim 2 include (n=64):
1)
women who are 38 years or older;
2)
have been born in Africa;
3)
speak English or French.
4)
Smartphone or computer with zoom (for virtual programs)
5.2
EXCLUSION CRITERIA
Exclusion criteria include: 1) do not agree to audio record their interview.
5.3
LIFESTYLE CONSIDERATIONS
N/A
5.4
SCREEN FAILURES
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study.
Individuals who do not meet the criteria for participation in this trial (screen failure) because of failing to 
meeting one or more inclusion criteria that are likely to change over time may be rescreened (e.g. age). 
Rescreened participants will be assigned the same participant number as for the initial screening.
5.5
STRATEGIES FOR RECRUITMENT AND RETENTION
As indicated in the proposal, human subjects will be recruited for in-depth interviews (N=30) and surveys 
(N=50), in Aim 1 to understand preferred language, cultural beliefs, access to health care; healthcare 
engagement, knowledge of breast cancer screening guidelines and predictors of screening behavior. 
Recruitment will take place within African immigrant communities in New York City. 
After incorporating the Aim 1 findings to our existing breast cancer educational program, 64 (n = 32 for 
English and n = 32 for French speaking) eligible African-born women will be recruited to pilot test the 
adapted educational program. Participants will be recruited from African immigrant communities in New 
York City.
Aim 1: Participants will be recruited from the community with the help of our community partner – African 
Services Committee. Our community partners will help us with our recruitment efforts by advertising the 
study within their organizations and at events and meetings they may hold for their consumers. 
Participants will be compensated $30 to a local store for participating in the research study. In addition, 
we will promote our study on social media (e.g. WhatsApp groups, Facebook pages) using  flyers and video 
advertisements adapted for online sharing.
Aim 2: Experienced outreach coordinators, assisted by our community partners, will recruit local 
community, faith-based, and other social organizations to host breast cancer educational programs as we 
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have successfully done for previous studies. Moreover, our outreach team has a database of more than 
100 faith- and community-based organizations with which we have developed relationships with and 
provided outreach and education for other studies. With the assistance of our partners, we will approach 
the leaders and gatekeepers of these organizations to present a breast cancer screening education 
program to their members. Research staff will focus on sites that include African-born immigrant women. 
A program will be scheduled by the coordinator and individuals at the community sites will be approached 
to participate in a breast cancer educational program. Some programs will also be held virtually. Some 
programs will be held in English and some in French; we will recruit participants who speak either English 
and/or French. Participants will receive an incentive for their time ($60 gift card to a local store). 
The study team has significant experience recruiting participants and have well-trained culturally 
competent research staff. We have well-established collaborative relationships with gatekeepers in the 
African immigrant community and have successfully recruited African-born immigrants into other studies. 
Our prior recruitment has demonstrated response rates of 70%-90%. 
6
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S)
6.1
STUDY INTERVENTION ADMINISTRATION
6.1.1
STUDY INTERVENTION DESCRIPTION
Aim 1 of the study is formative research for a cultural adaptation of the Witness Project. Aim 2 is a pilot 
test of the adapted program that will inform a larger trial to test the efficacy of the intervention.
The educational aspect of the program will be modeled after our current community based programs, as 
noted above, using narrative formats. The programs will disseminate relevant, up-to-date information for 
breast cancer to eligible African-born immigrant women. Trained staff will conduct the educational 
programs. Trained staff will enroll and collect data from English- and French- speaking African-born 
immigrants working with our consultants. Eligible individuals will be: 1) women who are 38 years or older; 
2) born in Africa; 3) read and speak English and/or French; 4) smartphone or computer with Zoom for 
virtual program participants. Information and resources about breast cancer and existing primary care 
clinical services, including the mobile mammography van operated by our institution as well as external 
mobile mammography van programs, will be available to all participants. We will inform both insured and 
uninsured participants about the Cancer Services Program and local clinical service resources for those 
without primary care physicians (PCPs) as well as questions to guide them about asking clinicians about 
breast cancer screenings when they have medical appointments.
The educational intervention program will include: a) reviewing of the IRB Research Information Sheet, b) 
confirmation of eligibility for the study, c) completion of a brief demographic survey and pre-program 
survey, d) narrative presentation with topics addressing the benefits of early detection of breast cancer 
through screening; education about disparities in breast cancer; education about disparities in breast 
cancer screening among African immigrant women; and the unique barriers and facilitators to screening 
for African immigrant women identified in Aim 1 of this study, e) interactive discussion / question/answers 
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session and f) completion of the post-program survey including feasibility questionnaire and feedback 
discussion. After the completion of the question and answer session, participants will be given breast 
cancer resource guides with local information about how and where to obtain screening. The program 
will take approximately 90 minutes to complete.  Participants will receive an incentive ($60 gift card) for 
their participation. Participants will complete a pre-program survey and a post-program survey to assess 
changes in HBM constructs. The post-program survey will also include a feasibility questionnaire. 62,63,64,65 
The programs will be evaluated using a program summary template that Jandorf and colleagues have used 
in previous studies. The summary collects information about the length of the program, number of 
participants attending the program, gender of program participants, location and site of the program, 
number of staff and volunteers present, and type of site (faith-based or community-based).
For both in person and virtual educational programs, demographic and pre-post surveys will be primarily 
collected via RedCap. For virtual programs, participants will be provided with RedCap survey links via chat. 
For in person programs, participants will be able to complete surveys through RedCap on their own 
devices or on devices provided by the study team. Hard copies of the surveys will also be available for 
completion for in person educational programs. All pre and post assessments, collected via RedCap or 
hard copy of surveys, will be linked only via participant study ID. Assessments will not collect any PHI. They 
will be anonymous as participant names will not be collected.
6.1.2
ADMINISTRATION AND/OR DOSING
For Aim 1 of the study, interested individuals will be invited to perform the study activities in a single 
session, in which they will express informed consent, provide demographic data and complete an in-depth 
interview or an interviewer-administered survey. Once consented, participants may also complete the 
demographic questionnaire and/or the interview or survey on another time and/or day of their choice, if 
so they prefer (i.e., because they feel fatigued; if they have limited continuous availability of time).
For Aim 2 of the study, research staff will focus on sites that include African-born immigrant women 38 
years of age and older. A program will be scheduled by the coordinator and individuals at the community 
sites will be approached to participate in a breast cancer educational program. Some programs will also 
be held virtually. We will conduct a total of eight programs in English (N=4) and French (N=4). We will 
recruit a total of 64 eligible women at each program. When recruiting program sites, the Research 
Assistant will emphasize the language in which the program will be conducted.
The administration of the intervention – including frequency, schedule, setting, and required personnel – 
will be determined using the input of individuals taking part in Aim 1 of the study.
6.2
FIDELITY
6.2.1
INTERVENTIONIST TRAINING AND TRACKING
N/A
6.3
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING
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N/A
6.4
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE
N/A
6.5
CONCOMITANT THERAPY
N/A 
6.5.1
RESCUE THERAPY
N/A 
7
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL
7.1
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION
N/A
7.2
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY
Participants are free to withdraw from participation in the study at any time upon request.
An investigator may discontinue a participant from the study for the following reasons:

Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives 

Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up)

Any event or medical condition or situation occurs such that continued collection of follow-up  
study data would not be in the best interest of the participant or might require an additional 
treatment that would confound the interpretation of the study

The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation
The reason for participant discontinuation or withdrawal from the study will be recorded on the Case 
Report Form (CRF).
7.3
LOST TO FOLLOW-UP
A participant will be considered lost to follow-up if he or she fails to complete an interview or survey and 
study staff are unable to contact the participant after at least 3 attempts. 
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The following actions must be taken if a participant fails to complete the study requirements:

The site will attempt to contact the participant, reschedule the missed interview or program  
within 2 weeks of the initial date, counsel the participant on the importance of their participation 
and ascertain if the participant wishes to and/or should continue in the study

Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts will be documented in the participant’s study file. 

Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up
8
STUDY ASSESSMENTS AND PROCEDURES
8.1
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS
Table 1 below summarizes the measure collected for this study.
After the completion of the interviews and surveys in Aim 1, a 3×3 table of themes categorized using the 
PEN-3 model 25 will be produced for each of the three components of the Witness Project: 1) addressing 
myths, barriers and values, 2) culturally relevant breast cancer narrative, 3) experiential breast education. 
Themes will be categorized in the following domains: cultural empowerment and relationships and 
expectations. These themes will inform how the intervention components for the educational narrative 
program should be adapted for an African immigrant audience. The themes will first be categorized 
according to barriers and facilitators to screening and then our team will decide which themes are 
appropriate. For example, barriers and facilitators from the cultural empowerment domain may include 
concerns about deportation, modesty, religiosity and healthcare screenings and will be addressed in the 
Witness Project component 1. Another example might be that barriers and facilitators from the 
Measure 
Source
Study Aim Number of Items Reliability
Demographics 
Study team
1,2
18
N/A
Breast Cancer Knowledge 
Study team
1,2
6
N/A
Self-Efficacy for Mammography
Champion, Skinner & Menon, 2005
1,2
10
α = 0.91
Breast Cancer Fear
Champion, Menon, Rawl & Skinner, 2004
1,2
8
α = 0.91
Medical Mistrust
Thompson, et al., 2004
1,2
12
α = 0.80
Perceived Risk/Susceptibility
Health Information National Trends Survey,  2005
1,2
2
α = 0.79
Perceived Benefits/Barriers to Mammography Adapted from Champion, Skinner & Menon, 2005
1,2
23
α = 0.73, α = 0.89 
Fatalism 
Powe et al., 1997
1,2
5
α = 0.88
Screening Behavior/Intentions
Adapted from O'Neill et al., 2008
1,2
4
N/A
Health Literacy
Chew et al., 2004
2
3
α = 0.76-0.887
Acculturation
Johnson-Agbakwu et al., 2014
2
38
α = 0.87
Feasibility and Acceptability
Vandelanotte & De Bourdeaudhuij, 2003
2
5
α = 0.79
Table 1. Study Measures
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relationships domain could include concerns about the role of patriarchy in women’s healthcare decision 
making – such as having a mammogram. This could potentially be addressed in the culturally relevant 
narrative (component 2). The cultural facilitators to screening identified in the interviews will be 
incorporated into the program by highlighting them as reasons to participate in screening. Cultural 
barriers identified will also be addressed in the culturally relevant narrative by providing examples and 
suggestions for coping with these perceived risks.
8.2
SAFETY ASSESSMENTS
Monitoring the progress of trials and the safety of participants. The proposed research is a low-risk 
behavioral trial. Research staff will carefully monitor each participant’s emotional reaction during 
interviews and offer a referral when appropriate. As per ISMMS IRB policies, the PIs are required to notify 
the IRB promptly of any unanticipated problems involving risks to study participants or others that occur. 
The PIs and study investigators will monitor the progress of the trial and safety of participants on an 
ongoing basis. The procedures of this study, such as regular meetings with research staff, will ensure 
discussion and reporting of all possible outcomes including adverse events. If the adverse event is due to 
the study and is unexpected, the PIs will draft a safety report and send a copy to the ISMMS IRBs. The IRB 
committees will serve as an objective review mechanism. This policy/procedure means that any potential 
conflict of interest inherent in the PIs being the sole reviewers of serious adverse advents is avoided. The 
Data and Safety Monitoring Board (DSMB) meets at least quarterly to review the results of adverse event 
reporting, protocol deviations, protocol audits and the conduct of the study. Each ISMMS study not 
otherwise overseen by an external DSMB is reviewed at least annually. The DSMB reports the analysis of 
their review to Sr. Vice President for Research and to the IRB. To avoid conflicts of interest, members of 
the DSMB are not involved in the oversight of studies for which they serve as Principal Investigator or Co-
Investigator/ biostatistician.
8.3
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS
Plans for assuring adherence with requirements regarding the reporting of adverse events (AEs) All serious 
adverse events (AEs) (e.g., medical occurrences resulting in death) that occur during the study defined by 
the given protocol, regardless of the relation to the research, must be reported to the IRB by telephone, 
e-mail or fax within 24 hours of the investigator’s awareness of the occurrence of the event. The PIs will 
report AEs to the ISMMS IRB and will disseminate information to other agencies as necessary. These initial 
reports are followed by a safety report which is a written account of a serious AE determined by a 
sponsor/investigator to be both related to the treatment under investigation and unexpected in nature. 
Serious AEs will be summarized annually in the IRB application for continuation or termination of research. 
All expected non-serious AEs that occur at a greater frequency or severity than anticipated and all 
unexpected non-serious AEs will be reported to the IRB within 15 working days of the Investigators 
becoming aware of the event. These AEs are also summarized annually in the IRB application for 
continuation or termination of the research. Plans for assuring that any action resulting in a temporary or 
permanent suspension of an NCI funded clinical trial is reported to the NCI grant program director 
responsible for the grant. Jessica Moise, Director, Grants and Contracts Office at ISMMS, will provide 
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prompt written notification of any action resulting in a temporary or permanent suspension of this 
protocol to the NCI grant program director responsible for the grant.
8.4
UNANTICIPATED PROBLEMS
8.4.1
DEFINITION OF UNANTICIPATED PROBLEMS
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP). OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria:
•
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 participant population being 
studied;
•
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and
•
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized.
8.4.2
 UNANTICIPATED PROBLEMS REPORTING 
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the Data Coordinating Center (DCC)/lead principal investigator (PI). The UP report will include 
the following information:
•
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number
•
A detailed description of the event, incident, experience, or outcome 
•
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP
•
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:  
•
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the DCC/study 
sponsor/funding agency within <insert timeline in accordance with policy> of the investigator 
becoming aware of the event 
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•
Any other UP will be reported to the IRB and to the DCC/study sponsor/funding agency within 
<insert timeline in accordance with policy> of the investigator becoming aware of the problem 
•
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) within <insert timeline in accordance with policy> of the 
IRB’s receipt of the report of the problem from the investigator
8.4.3
REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
N/A
9
STATISTICAL CONSIDERATIONS 
9.1
STATISTICAL HYPOTHESES
Descriptive statistics will provide summary information about the feasibility of recruitment, acceptability 
and cultural sensitivity of the program and satisfaction with the program. An arbitrary cutoff value of 80% 
acceptance will determine the interventions’ feasibility for the study. Some parameters include the 
proportion of eligible participants who are contacted, enrolled, agree, and disagree with the acceptability 
and cultural sensitivity of the program. Thus, if at least 80% of the participants exceed the previous 
parameters, the developed program will be determined to be feasible.

Primary Endpoints: 
We hypothesize that we will observe a change in the assessment of mammogram screening intention and 
knowledge of places where it is possible to obtain a mammogram appointment in the participants who 
will take part in the pilot test of the culturally adapted intervention (posttest), compared to baseline 
(pretest).

Secondary Endpoints:
We hypothesize that we will observe a change in assessment of perceived breast cancer risk and self-
efficacy for mammography in the participants who will take part in the pilot test of the culturally 
adapted intervention (posttest), compared to baseline (pretest).
9.2
SAMPLE SIZE DETERMINATION
We estimate that our sample size of 64 participants will generate a +/- 12% margin of error at a 95% 
confidence level.
9.3
POPULATIONS FOR ANALYSES
Per-Protocol Analysis Dataset
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Descriptive statistics will provide summary information about the feasibility of recruitment, acceptability 
and cultural sensitivity of the program and satisfaction with the program. An arbitrary cutoff value of 80% 
acceptance will determine the interventions’ feasibility for the study. Some parameters include the 
proportion of eligible participants who are enrolled, agree, and disagree with the acceptability and 
cultural relevance of the program. Thus, if at least 80% of the participants exceed the previous 
parameters, the adapted program will be determined to be feasible and acceptable. To determine 
program efficacy and sample size estimates for a future intervention, we will use a repeated measures 
ANOVA to analyze differences in the primary outcomes: screening intentions and HBM constructs (e.g., 
self-efficacy and perceived risk) immediately before viewing the educational program and immediately 
after viewing the program. We will conduct univariate and bivariate analyses of the data to provide 
descriptive summaries of the data, including demographics and responses to primary outcome measures.
We expect only minor amounts of missing data from the surveys and feasibility questionnaires. However, 
we will examine any patterns of missing data and if needed, consider using missing data imputation 
methods.
9.4
STATISTICAL ANALYSES
9.4.1
GENERAL APPROACH
For Aim 1 demographic characteristics of the participants will be reported. Data from the quantitative 
surveys will be analyzed to identify predictors of non-adherence to breast cancer screening. We will 
conduct univariate and bivariate analyses of the data to provide descriptive summaries of the data, 
including demographics and responses to primary outcome measures. Data from the audio-recorded in-
depth interviews  will be transcribed verbatim from audio recordings (using a transcription service). 
Analyses of the qualitative data will be conducted using the PEN-3 model, which is a method of analyzing 
data focusing on social processes and actions. The goal of our qualitative research is to identify the unique 
barriers and facilitators African immigrant women encounter with breast cancer screening. In line with 
this approach, the coding steps of open coding, axial coding, and selective coding will be used to identify 
categories and develop properties. Memoing will be conducted throughout the process. A constant 
comparative method will be used to generate theoretical categories and refine concepts.
For Aim 2, we will conduct univariate and bivariate analyses of the data to provide descriptive summaries 
of the data, including demographics and responses to primary outcome measures. Independent samples 
t tests will be used to compare changes in the primary outcomes measures pre-education and post-
education. Using a pre-post test design, we will analyze differences in the three primary outcomes: 
screening intentions, self-efficacy and perceived risk immediately before viewing the educational program 
and immediately after viewing the program.
To determine program efficacy and sample size estimates for a future intervention, a generalized linear 
modelling approach will be used with logistic regression. We will use a repeated measures ANOVA to 
analyze differences in the primary outcomes: screening intentions and HBM constructs (e.g., self-efficacy 
and perceived risk) immediately before viewing the educational program and immediately after viewing 
the program. We will conduct univariate and bivariate analyses of the data to provide descriptive 
summaries of the data, including demographics and responses to primary outcome measures.
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9.4.2
ANALYSIS OF THE ENDPOINT(S)
Quantitative Data Analysis: As the assessment will be administered as an interview, we do not anticipate 
much missing data. As needed, missing data will be imputed and then be used to estimate the parameter 
values for each of scales. We estimate that our sample size of 64 participants will generate a +/- 12% 
margin of error at a 95% confidence level. The primary outcomes are screening status (up-to-date with 
for mammography screening) and HBM constructs. As screening status is dichotomous, a logistic 
regression analysis will be conducted using socio-demographics and HBM constructs (e.g., self-efficacy, 
perceived risk, perceived benefits) as explanatory variables. Since Aim 1 is designed to provide 
information to inform the adaptation of the subsequent intervention and education, we shall adopt a less 
conservative criterion for statistical significance using a p-value equal to or less than 0.15. 
Qualitative Data Analysis. The PEN-3 model25 will guide the interpretation and analysis of the in-depth 
interviews. Using this model as a framework, the analysis approach will identify the unique barriers and 
facilitators related to African-born immigrants’ health care engagement. Transcripts will be reviewed 
using a  qualitative data management software. 50 Analysis will use a content analysis approach –  which 
includes  examining transcripts for salient categories of information supported by the text (e.g., barriers 
and facilitators to uptake of cancer screening in African immigrants). Themes that are extensively 
discussed by participants will be coded. Using a constant comparative approach, categories will be 
saturated until new information is no longer added. The research team will meet prior to conducting 
analysis to define coding labels and definitions. Potential labels and definitions will be drawn from 
identified barriers and facilitators for other preventive cancer screening exams (e.g., pap test, 
colonoscopy). All transcripts (including those translated from French to English) will be independently 
coded by PI Sly and research coordinators using the same framework to ensure consistency. They will 
meet multiple times to discuss the coding strategy for the first half of the interviews and discuss and 
resolve any coding discrepancies prior to coding of the remaining interviews, and again to resolve any 
remaining discrepancies by consensus. When there is disagreement on coding labels, the research team 
will meet to discuss reasons for disagreement and modify coding labels appropriately. Analyses will also 
examine subgroup differences (i.e., country of origin), age, and language. Our proposed sample size of 30 
in-depth interview participants will be stratified by language and we anticipate achieving saturation with 
these sample sizes. If saturation is not achieved with the 30 participants, we will recruit more participants 
with collaborators and community partners.
9.4.3
SAFETY ANALYSES
N/A
9.4.4
BASELINE DESCRIPTIVE STATISTICS
Descriptive statistics will provide summary information about the feasibility of recruitment, acceptability 
and cultural sensitivity of the program and satisfaction with the program.
9.4.5
PLANNED INTERIM ANALYSES 
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N/A 
9.4.6
SUB-GROUP ANALYSES
Subgroup analyses are not warranted because the intervention is intended for a specific population – 
African immigrant women over the age of 38. Additionally, because of the small sample size, subgroup 
analyses will not be adequately powered to detect differences in endpoints.  A future, large-scale trial will 
have the ability examine sub-group differences. 
9.4.7
TABULATION OF INDIVIDUAL PARTICIPANT DATA
Individual participant data will be listed by measure and time point (e.g. pre-post program assessments) 
9.4.8
EXPLORATORY ANALYSES
N/A
10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS.
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
10.1.1 INFORMED CONSENT PROCESS
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS
For Aim 1, consent forms describing in detail the study intervention, study procedures, and risks will be 
given to the participant and written documentation of informed consent will be completed prior to 
starting the study intervention.  The following consent materials are submitted with this protocol:

In-depth interview consent form (English and French) 

Survey consent form (English and French) 
For Aim 2, we have requested a waiver of written consent due to the extremely low risk of this research 
as no PHI will be collected from participants. We are unable to consent participants prior to the program 
because we will not have their contact information (as we are not collecting any PHI) – participants will 
be recruited and invited to the programs by community partners. We anticipate having up to 10 
participants in each program and we will have limited staff available to consent participants. Based on 
past experience, doing a full consent process with each individual participant is not feasible (for example, 
consenting procedures for Aim 1 have taken up to 45 minutes for some participants). Since participants 
will be part of group sessions, the time and study personnel needed to individually consent each 
participant would become an undue burden for the participants. Each individual will be informed of study 
procedures and will give informed consent through reviewing a Research Information Sheet and verbally 
confirming their willingness to participate before engaging in the research. This also allows participants 
to become anonymous since we are not collecting their names or signatures, and privacy is a 
demonstrated concern for this population. Individuals will review, either via RedCap or hard copy, the 
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Research Information Sheet that will provide details about the research study. If individuals agree to 
participate in the study, they will confirm their eligibility for the study. The following materials are 
submitted with this protocol:

Pilot intervention research information material based on waiver of written documentation of 
consent: Research Information Sheet (English and French)
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION
Aim 1: Participants will be recruited from African immigrant communities in New York City. We have a 
well-established collaborative relationship with gatekeepers in the African immigrant community and 
have successfully recruited African-born persons into prior studies and therefore anticipate successful 
recruitment for this proposed research. Participants will be recruited for in-depth interviews and surveys 
through IRB approved flyers at community sites and via social media platforms. Advertisements for 
recruitment will be in English and French and identical for both languages. A bilingual Research Assistant 
(English and French) will administer the in-depth interviews (n=30), which will take 60 minutes to 
complete and administer the surveys (N=50) which will take about 20 minutes to complete. 
Aims 2: Similar to recruitment for Aim 1, participant recruitment for Aim 2 will occur in African immigrant 
communities in New York City. After refining the education programs using the findings from Aim 1, 64 
new participants (n=32 per language) will view the culturally-adapted education breast cancer screening 
program, after reviewing the Research Information Sheet and confirming their eligibility.  
On the day of the program, participants will review, either via RedCap or with a hard copy, the Research 
Information Sheet that will provide details about the research study. 
In person programs:
After participants arrive at the program, but before study procedures begin, study team members will 
distribute to each participant hard copies of the Research Information sheet and/or online versions via 
RedCap link that participants can access on their own or study team provided devices. Study team 
members will review the Research Information Sheet with each participant, privately and one on one, and 
answer any questions. Participants will also have the ability to read through the Research Information 
Sheet. Study team members will tell participants that participation is voluntary and will not impact their 
ability to seek medical care at Mount Sinai, discuss the expectations of participation (participating in an 
educational program, completing surveys, giving feedback on the educational program), discuss 
compensation ($60 giftcard), communicate that no PHI will be collected (all information will be 
anonymous), and explain risks and benefits.
Virtual programs:
After participants arrive to the program Zoom Room, but before study procedures begin, study team 
members will put participants into breakout rooms, one by one, and provide copies of the Research 
Information sheet to each participant via RedCap link sent through Zoom chat. Within the zoom room, 
study team members will review the Research Information Sheet with each participant, privately and one 
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on one, and answer any questions. Participants will also have the ability to read through the Research 
Information Sheet. Study team members will tell participants that participation is voluntary and will not 
impact their ability to seek medical care at Mount Sinai, discuss the expectations of participation 
(participating in an educational program, completing surveys, giving feedback on the educational 
program), discuss compensation ($60 giftcard), communicate that no PHI will be collected (all information 
will be anonymous), and explain risks and benefits.
If individuals agree to participate in the study, they will confirm their eligibility for the study before being 
considered fully enrolled.
10.1.2 STUDY DISCONTINUATION AND CLOSURE
This study may be temporarily 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 to study participants, funding agency, and regulatory authorities. 
If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform 
study participants, the Institutional Review Board (IRB), and sponsor/funding agency and will provide the 
reason(s) for the termination or suspension. Study participants will be contacted, as applicable, and be 
informed of changes to study visit schedule.
Circumstances that may warrant termination or suspension include, but are not limited to:

Determination of unexpected, significant, or unacceptable risk to participants

Demonstration of efficacy that would warrant stopping   

Insufficient compliance of study staff to the protocol   (ie, significant protocol violations)

Data that are not sufficiently complete and/or evaluable

Determination that the primary endpoint has been met

Determination of futility
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies (OHRP, 
DSMB).
10.1.3 CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally-identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency. 
All research activities will be conducted in as private a setting as possible.
The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
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organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study. The clinical study site will permit access to such records.
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements.
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the Icahn School of Medicine at Mount Sinai. This will not include the 
participant’s contact or identifying information. Rather, individual participants and their research data will 
be identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites and by Icahn School of Medicine at Mount Sinai research staff will be secured 
and password protected. At the end of the study, all study databases will be de-identified and archived at 
the Icahn School of Medicine at Mount Sinai.
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies 
It is NIH policy that the results and accomplishments of the activities that it funds should be made available 
to the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 
security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
N/A
10.1.5 KEY ROLES AND STUDY GOVERNANCE
Principal Investigator
Jamilia Sly, PhD, Assistant Professor
Icahn School of Medicine at Mount Sinai 
One Gustave L Levy Place, Box 1077, New York, NY 10029
212-824-7813
Jamilia.sly@mssm.edu 
10.1.6 SAFETY OVERSIGHT
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of 
individuals with the appropriate expertise, including psychology and psychiatry. Members of the DSBM 
will be independent from the study conduct and free of conflict of interest. The DSMB will meet at least 
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semiannually to assess safety and efficacy data from each arm of the study. The DSMB will operate under 
the rules of an approved charter that will be written and reviewed at the organizational meeting of the 
DSMB. The DSMB will provide its input to the study sponsor.
10.1.7 CLINICAL MONITORING
N/A
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL
Each clinical site will perform internal quality management of study conduct, data and biological specimen 
collection, documentation and completion. All sites will follow a common quality management plan.
Quality control (QC) procedures will be implemented as follows:
Informed consent --- Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents.  This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed. 
Source documents and the electronic data --- Data will be initially captured on source documents (see 
Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study 
database.  To ensure accuracy site staff will compare a representative sample of source data against the 
database, targeting key data points in that review.
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern.
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities.
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported.
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data.  
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant consented/enrolled in the study.  Data recorded in the electronic case 
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report form (eCRF) derived from source documents will be consistent with the data recorded on the 
source documents. 
10.1.9.2 STUDY RECORDS RETENTION 
Study documents will be retained for a minimum of 5 years after the last approval of a marketing 
application in an International Council on Harmonisation (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 study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor/funding agency, if applicable. It is the responsibility of the 
sponsor/funding agency to inform the investigator when these documents no longer need to be retained.
10.1.9.3 PROTOCOL DEVIATIONS  
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) 
requirements. The noncompliance may be either on the part of the participant, the investigator, or the 
study site staff. As a result of deviations, corrective actions will be developed by the site and implemented 
promptly. 
These practices are consistent with ICH GCP: 
•
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3 
•
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1 
•
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2. 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 5 working days of 
the scheduled protocol-required activity. All deviations will be addressed in study source documents, 
reported to NIMHD Program Official and Icahn School of Medicine at Mount Sinai. Protocol deviations will 
be sent to the reviewing Institutional Review Board (IRB) per their policies. The site investigator will be 
responsible for knowing and adhering to the reviewing IRB requirements. Further details about the 
handling of protocol deviations will be included in the MOP.
10.1.9.4 PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations:
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication.
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
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such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals.  Data from this study may be requested from other researchers 5 years after the completion of 
the primary endpoint by contacting Jamilia Sly, PI.  Considerations for ensuring confidentiality of these 
shared data are described in Section 10.1.3.
10.1.10
CONFLICT OF INTEREST POLICY
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial. The study leadership in 
conjunction with the NIMHD has established policies and procedures for all study group members to 
disclose all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest.
10.2 ADDITIONAL CONSIDERATIONS
N/A
10.3 ABBREVIATIONS AND SPECIAL TERMS
AE
Adverse Event
ANCOVA
Analysis of Covariance
CFR
Code of Federal Regulations
CLIA
Clinical Laboratory Improvement Amendments
CMP
Clinical Monitoring Plan
COC
Certificate of Confidentiality
Co-I
Coinvestigator
CONSORT
Consolidated Standards of Reporting Trials
CRF
Case Report Form
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DSMB
Data Safety Monitoring Board
DRE
Disease-Related Event
EC
Ethics Committee
eCRF
Electronic Case Report Forms
EyV
Esperanza y Vida
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act of 2007
FFR
Federal Financial Report
GCP
Good Clinical Practice
GLP
Good Laboratory Practices
HBM
Health Belief Model
HIPAA
Health Insurance Portability and Accountability Act 
IB
Investigator’s Brochure
ICH
International Council on Harmonisation 
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ICMJE
International Committee of Medical Journal Editors
ISMMS
Icahn School of Medicine at Mount Sinai
IRB
Institutional Review Board
ISM
Independent Safety Monitor
ITT
Intention-To-Treat
MOP
Manual of Procedures
NCT
National Clinical Trial
NIH 
National Institutes of Health
NIH IC
NIH Institute or Center
NIMHD
National Institute for Minority Health and Health Disparities
NYC
New York City
OHRP
Office for Human Research Protections
PCP
Primary Care Physicians
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SMC
Safety Monitoring Committee
SOA
Schedule of Activities
SOP
Standard Operating Procedure
UP
Unanticipated Problem
US
United States
10.4 PROTOCOL AMENDMENT HISTORY
This is the first submission to IRB. 
Version
Date
Description of Change 
Brief Rationale
1.1
02/12/2021
1) Recruitment for Aim 1 decreased 
from 94 to 80 participants;
2) Focus groups with community 
leaders replaced by in-depth 
interviews;
3) Recruitment strategy updated to 
include social media (e.g. WhatsApp 
and Facebook) as a new channel 
Conducting individual 
interviews (up to 10 individual 
interviews) instead of 3 focus 
groups will better help the study 
team adhere to social distancing 
guidelines amid the COVID-19 
pandemic. Using social media to 
recruit potential participants is 
expected to help us better 
dealing with the challenges to 
enroll individuals when the 
access to the community and 
community events is restricted. 
1.2
4/22/21
A mistake in the protocol title was 
corrected.
A mistake in the protocol title 
was identified and corrected.
1.3
3/9/23
1) Aim 2 age eligibility changed to 
38 years of age or older.
2) Having had a mammogram in the 
previous 12 months was removed as 
an exclusion criteria for Aim 2.  
1) Women should be given the 
option to start screening for 
breast cancer at the age of 40 
and our primary endpoint 
outcome is intention to be 
screened within 2 years, so it is 
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3) The length of the Aim 2 
intervention increased from 60 to 90 
minutes.
4) Aim 2 compensation increased to 
$60.
5) The measures for primary 
endpoints have been refined.
6) Mention of research information 
material for Aim 2 was included.
7) Approach to qualitative data 
analysis was updated.
sound to include women under 
40. This is also based on the 
request a few participants have 
made about the inclusion of 
younger women in the 
educational program.
2) Our primary endpoint is 
intention to have a screening 
mammogram within 2 years, so 
it is sound to include women 
who have been screened 
recently.
3) We have also increased the 
length of the intervention from 
60 to 90 minutes to account for 
the assessments that participants 
will complete for research 
purposes.
4) Since the time of the 
intervention increased, the 
compensation amount has also 
increased in order to accurately 
reflect their time and effort.
5) Primary Endpoint: change 
from baseline assessment of 
mammogram screening 
intention and mammogram 
location and appointment.
Secondary Endpoints: change 
from baseline assessment of 
perceived breast cancer risk and 
self-efficacy for mammography.
6) Aim 2. We have requested a 
waiver of written consent due to 
the extremely low risk of this 
research as no PHI will be 
collected from participants. We 
are unable to consent 
participants prior to the program 
because we will not have their 
contact information (as we are 
not collecting any PHI) – 
participants will be recruited 
and invited to the programs by 
community partners. We 
anticipate having up to 10 
participants in each program 
and we will have limited staff 
available to consent 
participants. On the day of the 
program, participants will 
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review, either via RedCap or in 
person with a hard copy, the 
Research Information Sheet that 
will provide details about the 
research study. If individuals 
agree to participate in the study, 
they will confirm their 
eligibility for the study.
7) The study team decided to 
adopt a different, leaner 
approach to coding.
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11
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