Increasing Breast Cancer Screening in Chinese Immigrants
Phase: NA
Conditions: Screening Mammogram
Sponsor: Icahn School of Medicine at Mount Sinai

Increasing Breast Cancer Screening in Chinese Immigrants
PI: Dr. Lina Jandorf
NCT05089292
Document Date: July 22, 2020

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
 
HRP-503 PROTOCOL TEMPLATE 
 
Brief Summary of Research (250-400 words): 
The purpose of this study is to develop and pilot test a culturally- and linguistically-tailored health 
education intervention to increase breast cancer screening amongst Chinese immigrant women. 
The overall goal is to promote Chinese women to adhere to 1- and 2-year screening mammogram 
guidelines and complete follow-ups in a timely manner. Healthy People 2020 aims to have ~81% 
of screening eligible women undergo mammography; however, less than 61% of Chinese 
immigrant women across the U.S. meet screening guidelines. In New York City (NYC), 
immigration from China has increased ~50% in the past two decades. This rapid immigration 
makes NYC an ideal testing ground for investigating strategies to improve Chinese immigrant 
women’s adherence to screening mammography. Research with Chinese immigrants in NYC has 
revealed that only 23-30% of women from this community had ever had a mammogram in their 
lifetime. This is a population with great need for increased access to breast cancer education and 
screening. 
The Health Belief Model (HBM) provides a framework for addressing cultural health barriers 
related to preventive health care and cancer screening by positing that making a decision to 
engage in a health behavior is determined by weighing perceived threats versus benefits. Health 
education programs addressing individual and community-level barriers developed using HBM 
constructs, specifically the Witness Project, has successfully increased participants’ breast cancer 
knowledge and mammography screening uptake. The evidence-based Witness Project uses 
narrative communication (e.g., storytelling, personal testimonials) to educate, persuade, and 
engage target communities about cancer prevention and screening. The appeal and success of 
narrative communication stem from its familiarity as a basic mode of human interaction. Our 
work in minority and immigrant communities has demonstrated that narrative communication can 
increase participation in breast cancer screening. However, the efficacy of these interventions has 
not been empirically tested among Chinese immigrants. By integrating individual and 
community-level approaches, group-based narrative educational programs could play a 
significant role in promoting adoption and repeat use of breast cancer screening amongst Chinese 
women. 
1) Objectives 
 
We seek to identify cultural beliefs and attitudes Chinese immigrant women have toward breast 
cancer screening; and to utilize these findings to adapt and subsequently pilot test a narrative- 
based breast health education program for increasing screening mammograms in Chinese 
immigrant women. We hypothesize that our culturally- and linguistically-adapted breast health 
education program will improve screening mammography rates in Chinese immigrant women. 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
Aim 1. Culturally and linguistically adapt the Witness Project, a narrative-based breast 
cancer education program for Chinese immigrant women. We will conduct individual 
interviews with community members (n=30) and gatekeepers/stakeholders (n=30) and draw 
from our preliminary work and literature review to identify and test components of the Witness 
Project that should be adapted for Chinese immigrant women. Preferred language, English 
language proficiency, cultural beliefs, access to health care, preferred format (group-based vs. 
individual education), knowledge of breast cancer screening guidelines, and HBM predictors 
of screening behaviors will be assessed. 
 
To be submitted later: 
Aim 2. Pilot test feasibility and acceptability of the Witness Project for Chinese immigrant 
women. We will pilot test the adapted intervention using 12 programs (4 each in Cantonese, 
Mandarin, and English) to assess feasibility and acceptability and to determine effect sizes 
for a future large-scale trial. Receipt of screening mammography and intentions to undergo 
mammography, as well as other HBM constructs (i.e., perceived risk, barriers, fatalism, and 
breast cancer knowledge) will be compared in a pre-post test design stratified by language 
(N=96). 
 
2) Background 
 
Although there are multiple social/environmental determinants of cancer screening, screening 
involves an individual deciding whether or not to engage in the screening behavior.48,49 The HBM 
asserts that an individual’s attitudes and beliefs (e.g., perceived benefits, perceived barriers) will 
determine their behavioral intentions.50 Therefore, improving breast cancer screening rates in 
Chinese immigrant women requires a deep understanding of the factors that influence decisions 
about breast cancer screening uptake. Health decision-making models theorize 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).1-3 Expected 
utility and Social Cognitive Theory constructs, such as observational learning through modeling 
of screening mammogram exams have been shown to predict engagement in cancer screening 
behaviors.4-7 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.8-14 
However, to our knowledge, few studies have focused on attitudes and beliefs regarding 
breast cancer screening exams among Chinese immigrant women. Chinese immigrant women in 
NYC emigrated primarily from Fujian province, a very low resource region, and are linguistically, 
socioeconomically, and culturally different from Chinese women who have settled elsewhere in 
the US.15-19 Studies conducted by Chen20 and Chen et al.21 found that only 54-67% of Chinese 
immigrant women in NYC had ever had a clinical breast exam and only 23% had ever completed 
a mammogram. Their studies also reported that English-speaking ability and greater years spent 
in the US were positive significant predictors of having undergone a clinical breast 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
examination.20,21 Culturally specific barriers and facilitators were not examined, which could have 
provided more information on how to address the breast cancer screening needs of this population. 
We found no existing intervention targeting mammography screening in NYC Chinese 
immigrants, though pilot studies with Chinese immigrants elsewhere in the US have indicated that 
improving access, knowledge, and attitudes toward breast cancer screenings through health 
education programs can improve breast cancer screening intentions.22-26 
Our preliminary work with Chinese women in NYC show that only 30% have had a 
mammogram in the past year and only 64% have had a mammogram within the past 2 years 
(manuscript under review). Because we were unable to assess years in the US or immigrant status 
in our preliminary work, we expect these numbers to be much lower for NYC Chinese women 
who are immigrants. Nonetheless, our findings demonstrate the need for education regarding 
breast cancer screening and adherence to screening mammogram guidelines within this 
population. 
We have conducted robust, culturally-targeted outreach into several minority communities. 
The Witness Project (WP) is a community-based breast cancer education program designed to 
meet educational and cultural levels of underserved African American women. The WP model is 
a belief and theory-based intervention incorporating the HBM, locus of control beliefs, social 
learning theory, transtheoretical model of change and the 4MAT System.27,28 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 
(PI) et al. successfully replicated WP in 22 states at 40 unique sites including NYC.29-30,27- 
28,31Replication was achieved using an implementation guide, locally produced, award winning 
video, and training curriculum developed by Erwin and Jandorf (now on NCI Cancer Control 
Planet RTIP). In NYC, we conducted hundreds of programs at a variety of community sites and 
have educated over 3,000 participants.32-35 This research demonstrates our ability to reach 
culturally targeted members in the community and our experience of over 15 years in community- 
based research. 
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 
(PI) and colleagues initiated EyV to expand this breast educational program among Latina 
populations in a culturally and linguistically congruent, community-based approach.33,34 EyV 
development was conducted with members of the target group, including qualitative studies, to 
ensure the adaptation would be culturally appropriate and meaningful.34-36 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.34,37 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. 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
Narrative communication methods are a widely recognized tool for mitigating barriers and 
effectively increasing a variety of health behaviors including cancer screening.38,39 Transporting 
narratives, or immersion into a story, can successfully change beliefs and motivate action.40 
Narrative communication is a comfortable way of presenting information because people 
communicate with each other and learn in everyday life primarily through stories.15 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.1 People with 
personal experiences make credible, believable messengers. Additionally, narratives can be 
particularly useful for conveying cancer information because they reduce counterarguments which 
can help individuals overcome barriers to seeking treatment.40 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.40 
Four distinct capabilities of narrative health communication are: “overcoming resistance, 
facilitating information processing, providing surrogate social connections, and representing 
emotional and existential issues.”41 Narrative means of communication have been shown to lead 
to significant emotional responses, which subsequently have a large impact on behavioral 
decisions.42,43 This feature is a major strength of the narrative approach.38 
There is substantial evidence that community-based group narrative education cancer 
screening programs can be effective in fostering positive health behavior change.28,29,39,44 Narrative 
communication has been shown to reduce message counterarguments, increase positive affect, 
foster identification with the communicator and lead to better engagement with the message; 
thereby reducing perceived barriers, increasing message recall, and promoting discussion with 
family members.39,45 One study has found that participants exposed to narrative messages were 
two to four times more likely to engage in health promoting actions and information-seeking 
behavior than those unexposed.46 While numerous studies have illustrated the success of narrative 
communication over didactic communication in terms of various types of behavior change, 
narrative education formats have not been developed within the context of Chinese immigrants. 
However, one study with immigrant women in Canada suggests Chinese women might be 
receptive to interventions involving narrative stories.47 
Replicating and expanding the application of this model to Chinese immigrant women will 
not only potentially improve the health outcomes of this population, but can also demonstrate the 
effectiveness of the HBM in yet another minority population, increasing the robustness of this 
approach. 
 
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Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
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Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
18. McGlinn LA. Beyond Chinatown: Dual immigration and the Chinese population of 
metropolitan New York City, 2000. Middle States Geographer, 2002, 35:110-119. 
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26. Berger, S., Huang, CC. & Rubin, C.L. The Role of Community Education in Increasing 
Knowledge of Breast Health and Cancer: Findings from the Asian Breast Cancer Project in 
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27. Hurd TC, Muti P, Erwin DO, Womack S. An evaluation of the integration of non-traditional 
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Programs. Progress in Community Health Partnerships: Research, Education, and Action 2(3), 
195-204. Johns Hopkins University Press. Retrieved June 6, 2019, from Project MUSE database. 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
31. Sudarsan, N.R., Jandorf, L. & Erwin, D.O. Multi-Site Implementation of Health Education 
Programs for Latinas. J Community Health (2011) 36: 193. https://doi- 
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ability, and mammography use in Chinese American women. Health Educ Behav. 
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Cancer Screening Among Latinas Attending Culturally Specific Educational Programs. Progress 
in Community Health Partnerships: Research, Education, and Action. 2008;2(3):195-204. 
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the impact of health messages and navigation in a cluster-randomized study. Journal of Racial 
and Ethnic Health Disparities. 2014;1(2):85-100. 
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cervical cancer education program. Journal of cancer education : the official journal of the 
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women's screening behavior: a qualitative approach. Health education research. 2013;28(5):772- 
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Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
45. Dillard AJ, Fagerlin A, Dal Cin S, Zikmund-Fisher BJ, Ubel PA. Narratives that address 
affective forecasting errors reduce perceived barriers to colorectal cancer screening. Social 
science & medicine. 2010;71(1):45-52. 
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positive health behavior: A pilot study. Preventive medicine. 2010;51(2):178-181. 
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Cancer Screening Promotion: Arabic, Chinese, South Asian, and Vietnamese Immigrant 
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Medicine. 2004;38(5):536-550. 
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1984;11(1):1-47. 
 
3) Setting of the Human Research 
Due to the COVID-19 pandemic, all interviews will be conducted over the phone and audio 
recorded so that we can create transcripts of the information. Participant recruitment, as well as 
pilot testing of the educational intervention in Year 2 will be conducted at community and faith- 
based partner sites, including, but not limited to: 
 
Saint Margaret’s House: 49 Fulton Street, New York, NY 10038 
Henry Street Settlement: 334 Madison Street, New York, NY 10002 
Chinese American Planning Council: 4101 8th Avenue, Brooklyn, NY 11232 
 
 
4) Resources Available to Conduct the Human Research 
Our team has successfully recruited Chinese-speaking participants into previous research (e.g., 
IRB-18-00111) and have demonstrated prior recruitment rates of over 70% from immigrant and 
minority groups. The PI, Jandorf is a Professor and the Director of the Office of Community 
Engagement at the Tisch Cancer Institute at Mount Sinai. She is an expert in qualitative research 
and has over 20 years of experience conducting community-based research. Furthermore, we 
have strong collaborations with community site leaders who have helped recruit participants and 
hosted programs with us in the past (and have provided a Letter of Support for this proposal). 
Thus, we are confident that we will be able to identify and consent 60 eligible subjects (30 
community members and 30 gatekeepers/stakeholders) for qualitative interview calls for Aim 1. 
5) Study Design 
a) Recruitment Methods 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
All participants will be recruited from Chinese immigrant communities in NYC. We have 
well-established collaborative relationships with gatekeepers from over 50 community 
organizations serving the Chinese immigrant community) and have successfully recruited 
Chinese immigrant women into prior studies (manuscripts under review), and therefore 
anticipate successful recruitment for this proposed research. 
For Aim 1: 
As we have done before, we will distribute IRB-approved flyers through various venues 
(e.g., at community sites, community newsletters, community listservs) and will ask partner 
site staff to identify/reach out to individuals who might be interested and share our contact 
information with these individuals. All participants will receive $30 for their participation. 
HIPAA authorization and informed consent will be obtained prior to participation. 
Individuals who are interested in participating will work with our research staff to set up a 
time for a phone interview at the time most convenient for them. At this time, all aspects of 
the study will be explained and those interested in participating will undergo the informed 
consent process. Signed consent will be captured electronically through the RedCap platform 
or via phone consent with a witness. 
 
 
b) Inclusion and Exclusion Criteria 
For the qualitative interviews (Aim 1): 
Inclusion criteria: 
Individuals are eligible to participate in the community member interviews if they are: 
1) 40 years of age or older, 
2) female, 
3) born in China, and 
4) speak Cantonese, Mandarin, or English 
 
Individuals are eligible to participate in the gatekeeper/stakeholder interviews if they are: 
1) 18 years of age or older and: 
2) a leader in the Chinese immigrant community or 
3) are affiliated with a Chinese-serving organization 
Exclusion criteria: 
Individuals who do not agree to be audio recorded will be excluded. 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
c) Number of Subjects 
We aim to enroll 60 individuals (30 community members and 30 gatekeepers/stakeholders) for 
the individual interviews in Aim 1. 
 
d) Study Timelines 
 
Duration of an individual subject's participation in the study: 
o Individual interview (including consent): 45-60 mins 
Duration anticipated to enroll Aim 1 study subjects: 12 months 
Estimated dates for the investigator to complete the study: 2 years 
 
e) Endpoints 
N/A 
f) Procedures Involved in the Human Research 
For Aim 1, individuals who consent will be invited to participate in audio-recorded interviews 
regarding Chinese immigrant women’s views and experiences with breast cancer screening, 
potential barriers and facilitators to utilizing screening mammograms, and beliefs about breast 
cancer. Interviews are expected to last 45-60 minutes. We will interview subjects at various 
times and days to accommodate their schedules (e.g., evenings, weekends) and in Cantonese, 
Mandarin, or English, as preferred. All participants will receive a $30 gift card as an incentive 
for participating. 
Each participant will receive a $30 giftcard for participating. 
g) Specimen Banking 
N/A 
h) Data Management and Confidentiality 
We will collect name and phone number and/or email of potential subjects in order to contact 
them. After the subject is done with study and gift card has been sent, we will remove 
subject’s phone number and/or email collected. All data will be de-identified and participants 
will be assigned a numeric code linked with their data so they cannot be identified in study 
data analyses, publications, or presentations. Only the PI and approved study personnel will 
have access to the files. Any physical copies of identifying information will be kept in locked 
cabinets until the information can be transferred into electronic form, at which point any 
physical copies will be destroyed. All data will be saved on the department’s secure, 
encrypted server. This data will be stored for 7 years. 
i) Provisions to Monitor the Data to Ensure the Safety of Subjects 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
This study does not involve more than minimal risk to subjects. 
j) Withdrawal of Subjects 
A subject may request to withdraw from the study at any time by notifying the PI (or if 
withdrawal occurs during the interview or educational program, the research assistant). The 
PI’s email and phone number will be provided to all participants prior to beginning the 
interviews or programs and will be listed on the consent forms. 
Procedures for Investigator to Withdraw Subjects: 
There are no anticipated circumstances under which subjects will be withdrawn from the 
research without their consent. 
 
5) Risks to Subjects 
Some participants may become stressed or anxious when thinking or discussing breast 
cancer, undergoing screening, and potential development of breast cancer. 
 
To minimize risk in our study, research personnel will adhere to a strict protocol developed by 
the PI and Co-Is. Prior to starting the interview or program, research assistants will inform 
participants of the potentially sensitive nature of the topic and remind participants of their right 
to withdraw from the study at any time or to decline to answer any questions that make them 
feel uncomfortable. 
6) 
Provisions for Research Related Harm/Injury 
This study involves minimal risk to subjects. 
7) Potential Benefits to Subjects 
Subjects might not derive any direct benefit from the research. However, possible benefits to 
subjects may be increased knowledge about breast cancer, breast health, and breast cancer 
screening. 
8) Provisions to Protect the Privacy Interests of Subjects 
Collected information will be stored on the department’s secured intranet drive. Following 
participation and after gift cards have been mailed/emailed to the subject, we will not need to 
keep any contact information and will delete this information from files. 
Confidentiality of each subject's information will be protected with utmost care. All subjects 
will be assigned a numeric code for record-keeping purposes. A cross-referencing file 
containing identifying information and numeric codes will be password protected and stored 
on the Department’s secured intranet drive and will only be accessible to the PI and approved 
study personnel. In addition, all data will kept in a file on the encrypted on the Department’s 
intranet drive. Any and all physical documents with subject information will be kept in a locked 
file cabinet in the PI’s office at the Icahn School of Medicine at Mount Sinai until they are 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
scanned (and the paper copies destroyed) and stored on the Department’s secure intranet drive 
in a password-protected file accessible only to the study staff. 
9) Economic Impact on Subjects 
There are no anticipated economic impact on the participants. We will provide subjects with a 
$30 gift card as a token of appreciation for their time. 
10) Payments to Subjects 
Subjects will receive a $30 gift card as a token of appreciation for their time. 
11) Consent Process 
The standard “SOP HRP-090 Informed Consent Process for Research” will be utilized 
to obtain permission from subjects to participate in the research study. 
 
Eligible patients who are interested in the study will be provided with the informed consent 
form. Research assistants will go through the consent form with eligible patients and answer 
any questions. For Aim 1, informed consent will be conducted through the RedCap platform, 
modeled after the standard MSH informed consent form, or via phone consent with a witness, 
depending on patient preference. 
 
The consent form will explicitly state that the study involves research regarding Chinese 
immigrant women’s barriers and facilitators to breast cancer screening. It will include that risk 
to the patient is minimal. We will explain that data will be de-identified and kept encrypted 
and password protected. We will explain who and how to contact for answers to pertinent 
questions about the research and research subjects’ rights, including withdrawal processes. The 
consent will include a statement that participation is voluntary, refusal to participate will 
involve no penalty or decrease in benefits to which the subject is otherwise entitled, and that 
the subject may discontinue participation at any time without penalty or loss of benefits to 
which the subject is otherwise entitled. 
Children 
Children will not be enrolled in this study because children are not routinely screened for breast 
cancer. 
Cognitively Impaired Adults – N/A 
English and Chinese (both Mandarin and Cantonese) speaking Chinese women will be 
allowed to participate in the study. 
 
12) Process to Document Consent in Writing 
The standard PPHS consent template will be used, “SOP-091 Written Documentation of 
Consent.” For Aim 1 participants, consent will be documented electronically via REDCap or 
over the phone with a witness, depending on participant preference. 

 
Protocol Name: 
Increasing breast cancer screening in Chinese immigrants 
Principal Investigator: 
Lina Jandorf 
Primary Contact 
Name/Contact Info: 
Suzanne Vang, Suzanne.vang@mssm.edu, 212-824-7641 
Date Revised: 
July 22, 2020 
Study Number: 
GCO 19-1320 
 
 
13) Vulnerable Populations 
Indicate specifically whether you will include (target) or exclude each of the 
following populations: 
 
Include 
Exclude 
Vulnerable Population Type 
X 
Adults unable to consent 
X 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
X 
Wards of the State (e.g. foster children) 
X 
Pregnant women 
X 
Prisoners 
 
Some women participating in the study may be pregnant. Women who are pregnant will not 
be excluded from our study, as pregnant women are not prohibited from receiving routine 
screening mammograms. 
 
14) Multi-Site Human Research (Coordinating Center) 
N/A 
15) Community-Based Participatory Research 
N/A 
16) Sharing of Results with Subjects 
N/A 
17) External IRB Review History 
N/A 
18) Control of Drugs, Biologics, or Devices 
N/A