BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Phase: NA
Conditions: Breast Cancer
Sponsor: Vanderbilt University Medical Center

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BRAVE Strategy 
Breast cancer Risk Assessment – achieving Equity 
 
STUDY PROTOCOL 
 
NCT05051631 
 
 
 
 
 
 
Study Principal Investigator: 
Lucy Spalluto, MD MPH – Vanderbilt 
 
Additional Investigators: 
Carolyn Audet, PhD - Vanderbilt 
Maureen Sanderson, PhD MPH - Meharry 
Rebecca Selove, PhD MPH - TSU 
 
 
 
 
 
 
 
 
Original Protocol Version: 09/28/2021 
 
 
**Vanderbilt will be the only site recruiting, consenting interacting with participants, and 
following this study protocol.   
 

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1. 
STUDY SUMMARY .................................................................................................................................................................... 3 
2. 
RATIONALE ............................................................................................................................................................................... 3 
3. 
OBJECTIVES .............................................................................................................................................................................. 3 
4. 
PERSONNEL .............................................................................................................................................................................. 3 
5. 
RESEARCH DESIGN AND METHODS .......................................................................................................................................... 4 
5.1 FEASIBILITY.......................................................................................................................................................................................... 4 
5.1.1 Purpose .................................................................................................................................................................................... 4 
5.1.2 Feasibility Assessment ............................................................................................................................................................. 4 
5.1.3 Data Analysis ........................................................................................................................................................................... 5 
5.2 REACH................................................................................................................................................................................................ 5 
5.2.1 Purpose .................................................................................................................................................................................... 5 
5.2.2 Design ...................................................................................................................................................................................... 5 
5.2.3 Implementation Periods (Control, Implementation, Maintenance) ........................................................................................ 5 
5.2.4 Recruitment and Eligibility....................................................................................................................................................... 5 
5.2.5 Remuneration .......................................................................................................................................................................... 6 
5.2.6 Data Collection Methods ......................................................................................................................................................... 6 
5.2.7 Consent .................................................................................................................................................................................... 6 
5.2.8 Data Analysis ........................................................................................................................................................................... 6 
5.3 ACCEPTABILITY AND APPROPRIATENESS .................................................................................................................................................... 7 
5.3.1 Purpose .................................................................................................................................................................................... 7 
5.3.2 Healthcare Team Survey .......................................................................................................................................................... 7 
5.3.3 Healthcare Team Interviews .................................................................................................................................................... 7 
5.3.4 Patient Interviews .................................................................................................................................................................... 8 
5.3.5 Data Analysis ........................................................................................................................................................................... 9 
6. 
TOTAL RECRUITMENT ............................................................................................................................................................... 9 
6.1 FEASIBILITY.......................................................................................................................................................................................... 9 
6.2 REACH................................................................................................................................................................................................ 9 
6.3 ACCEPTABILITY AND APPROPRIATENESS .................................................................................................................................................... 9 
7. 
REPORTING OF ADVERSE EVENTS OR UNANTICIPATED PROBLEMS INVOLVING RISK TO PARTICIPANTS OR OTHERS ............... 9 
8. 
STUDY WITHDRAWAL/DISCONTINUATION ............................................................................................................................. 10 
9. 
PRIVACY/CONFIDENTIALITY ISSUES/DATA SAFETY MONITORING .......................................................................................... 10 
10. 
FOLLOW-UP AND RECORD RETENTION ................................................................................................................................... 10 
 
 
 

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STUDY PROTOCOL 
 
1. Study Summary 
 
Breast cancer mortality disparities in young women result in increased early loss of life amongst women from 
low socioeconomic status, those dwelling in rural areas, and those from racial minority groups. Access to care, 
delays in diagnosis and treatment, and differences in tumor biology partially explain these disparities. Identifying 
racially, geographically, and socioeconomically diverse young women at high risk for breast cancer offers an 
opportunity to reduce cancer disparities through early screening and detection of breast cancer. Integrating the 
use of existing breast cancer risk assessment (RA) tools into clinical care is a means to identify these young 
women. 
 
2. Rationale 
 
While RA is recommended for all women no later than age 30, this has not yet been translated to clinical practice 
and thus women are not receiving RA prior to the age of 50 years when screening is recommended for those at 
average risk. Women at high risk, in contrast, should start screening as young as age 25 (e.g., for those identified 
to have a BRCA1 or BRCA2 mutation). As most women ages 25-49 years of age do not now receive RA, and 
breast cancer in these women presents with a more aggressive phenotype at later stage associated with inferior 
outcomes, implementation strategies for RA in this age group should be developed. If women age 25-49 receive 
RA and are identified as high-risk, they can be screened earlier than age 50 to diagnose cancer at an earlier 
stage, when the disease is most successfully treated.  
 
3. Objectives 
 
The central goal of this study is to test strategies to implement evidence-based breast cancer RA in healthcare 
clinics in Tennessee. The strategies that we will test include engaging a site champion at each clinic, offering 
tailored provider education, and offering tools to increase patient awareness of breast cancer RA. The BRAVE 
study aims to assess the feasibility, reach, acceptability, and appropriateness of these select customized 
strategies to increase uptake of breast cancer RA. We will achieve these aims through a conducting a stepped-
wedge trial employing a mixed methods study design. The primary outcome is the proportion of women age 25-
49 having RA. Secondary outcomes include the numbers of women: 1) identified as high-risk; 2) pursuing risk-
adherent screening; and 3) diagnosed with breast cancer. Implementation outcomes include reach, feasibility, 
acceptability, and appropriateness. Data collected will inform a future multi-site cluster randomized clinical trial 
to test the implementation strategies on a larger scale over a longer duration, enriched for underserved 
populations such as minority and rural dwellers. 
 
4. Personnel 
 
Lucy Spalluto, MD MPH (Lead PI, Vanderbilt Site PI): Dr. Spalluto, a board-certified breast imaging radiologist 
and health services researcher, has community partnership building skills and expertise in community-engaged 
research, implementation science and addressing breast cancer disparities. She has demonstrated this capacity 
through her work to engage underserved populations in the screening mammography. Dr. Spalluto has an 
established relationship with the Tennessee Breast and Cervical Screening Program, a part of the Tennessee 
Department of Health.  She will leverage this relationship for recruitment purposes. 
Maureen Sanderson (Meharry): Dr. Sanderson has extensive cancer epidemiology and community-based 
participatory research experience and offers expertise in data analysis and results interpretation.  
Rebecca Selove (Tennessee State University): Dr. Selove is a clinical psychologist with expertise in 
implementation science and community-engaged research specializing in addressing challenges associated with 
implementation of new interventions to support individual behavioral change.  
Carolyn Audet, PhD (Vanderbilt): Dr. Audet offers additional expertise in implementation science, community 
engaged research, and qualitative research. 

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Veronica Mallett, MD MMM (Meharry): Dr. Mallett offers expertise in women’s health research. 
Tennessee Breast and Cervical Screening Program (TBCSP):  The study team has a longstanding relationship 
with the TBCSP.  The TBCSP is affiliated with community healthcare clinics across the state of Tennessee and 
will facilitate making direct connections with clinics and potential study participants.   
 
5. Research Design and Methods 
5.1 Feasibility 
5.1.1 Purpose 
 
Test the feasibility of implementing strategies to increase uptake of breast cancer RA. 
5.1.2 Feasibility Assessment 
 
Presentation of Potential Strategies: 
The Vanderbilt study team will give a short presentation demonstrating the proposed strategies to increase 
breast cancer RA. Strategies include engaging a site champion, offering provider education, and offering 
methods to increase patient awareness of breast cancer RA. The presentation will be either in person or virtual 
as necessary per COVID restrictions. The presentation is expected to take approximately 15 minutes and will 
demonstrate strategies such as how a site champion will engage with the research team to share information 
with clinics, how provider education can be offered to the sites, and how patient awareness materials could be 
presented. 
Following the presentation, the Vanderbilt team will distribute a web-based voluntary, anonymous REDCap 
survey to clinic providers and staff.  This survey is an adapted version of the validated Feasibility of Intervention 
Measure (FIM), a 4-item scale that measures provider perception that a given practice can be easily or 
conveniently performed. Questions are asked on a Likert-like scale (1, Completely Disagree – 5, Completely 
Agree) with both FIM sum and mean scores calculated. Higher scores indicate higher feasibility. [see REDCap 
Survey - Feasibility] 
Following completion of the survey, clinic providers and staff will be invited to participate in a brief listening 
session to share their thoughts on the strategies presented. [see Listening Session Guide - Feasibility] 
Recruitment and Eligibility: The Vanderbilt study team will perform the Feasibility Assessment in up to 10 clinics 
in Tennessee. The Vanderbilt team will recruit clinics to participate in the Feasibility Assessment leveraging 
existing relationships through the TBCSP to identify potential participants [see Recruitment Email – 
Feasibility]. The Vanderbilt team will respond via email or phone to answer additional questions potential clinics 
may have. The Vanderbilt team will recruit individuals at each participating clinic at the time of the feasibility 
presentation to participate in the Feasibility Assessment [see Information Sheet – Feasibility]. The Vanderbilt 
team will answer any questions potential participants may have. The survey sample will consist of approximately 
60 individuals. Sample size at individual clinics may vary due to differences in the number of providers and staff 
at each clinic. Eligible individuals will be age 18 and older and will be a provider, staff, or administrator employed 
in a clinic enrolled in the study. 
Data Collection Methods: Data from the anonymous, voluntary survey will be collected and stored via REDCap, 
a secure online data collection tool. The listening sessions will be digitally recorded via audio recorders with 
participant permission, transcribed verbatim, and coded by two research team members using a codebook. If 
participants choose not to be recorded, the interviewer will take notes on their responses. Any identifying 
information that are part of the participants’ responses will be removed from the transcriptions.  Original listening 
session recordings will be destroyed once transcribed. The responses to all the listening sessions will be 
summarized.  When the specific responses from individual organizations are quoted, the organization or person’s 
name will not be identified. 
Consent: We will request a Waiver of Consent for the Feasibility Assessment.  Consent will be implied by 
completion of the survey and participation in a listening group. 
 

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5.1.3 Data Analysis 
Continuous measurements will be summarized using mean + standard deviation or median/interquartile range. 
tables and graphs will be created to describe and visualize data. Qualitative data will be analyzed using inductive 
coding to identify emerging themes. 
5.2 Reach  
5.2.1 Purpose 
Conduct a trial to evaluate the impact of breast cancer RA implementation strategies on the proportion of eligible 
women receiving RA (reach). The intervention in this trial is the use of implementation strategies including 
identifying a site champion, offering provider education, and providing tools to increase patient awareness of RA. 
The working hypothesis is that implementing this bundle of selected strategies to increase utilization of breast 
cancer RA will increase the proportion of eligible women (age 25-49) having RA performed when compared to 
usual care. 
5.2.2 Design 
The BRAVE trial is a real-world cross-sectional trial. The trial intervention is the implementation of the bundle of 
selected strategies to increase uptake of breast cancer RA (Fig. 1). No clinics are exposed to the intervention at 
the beginning of trial. Subsequently, each clinic will receive the intervention. Data will be collected before and 
after intervention, so that each clinic contributes observations under both control and intervention conditions. 
Ultimately, all clinics will receive the same intervention. The primary outcome is the proportion of eligible women 
(women age 25-49) who receive breast cancer RA. 
5.2.3 Implementation Periods (Control, Implementation, Maintenance) 
Control: Baseline data on reach will be collected through electronic health record or data collection forms (see 
section 5.2.6 - Data collection methods).  
Implementation: During the implementation period, the research team will identify and engage the site champion 
and the research team. The research team will deliver tailored in-person provider education and provide clinics 
with tools to increase patient awareness of breast cancer risk assessment. The research team will also 
participate in clinic staff meetings to answer questions about breast cancer RA, discuss barriers to performing 
RA, and provide feedback on the clinic’s use of RA. Final versions of education and awareness materials have 
been submitted and approved by the IRB.  
Maintenance: Implementation strategies will no longer be offered. The maintenance period will consist of data 
collection only. 
5.2.4 Recruitment and Eligibility 
The Vanderbilt team will recruit 10 individual clinics to participate in the trial. We will apply eligibility criteria to 
purposively select geographically diverse clinic sites serving racially diverse populations. First, clinics must be 
located within approximately 2-hour driving distance of Nashville, Tennessee, where the program coordinator is 
housed to maintain frequent contact with the clinics. Second, clinics must identify a champion to work with the 
research team and serve as the primary contact. Third, the clinic must serve a racially diverse population of 
women. Fourth, the clinic must have an electronic health record. We will recruit two back-up clinics meeting 
these selection criteria in case a site drops out during the early phase of the study. The Vanderbilt team will 
reach out to potential clinics with the guidance of our established relationship with the TBCSP via email or in 
person and provide a study information sheet for potential clinics [see Recruitment Email – Clinic, Information 
Sheet – Clinic]. The Vanderbilt team will respond via email or phone to answer additional questions potential 
clinics may have regarding enrollment. 
At the clinics enrolled in the study, we will collect data retrospectively from individual health records on patients 
who are seen by the clinic. We anticipate that we will collect clinical data on approximately 3,000 women during 
the time of the stepped-wedge trial. Inclusion criteria for individual records will be women, age 25-49.  Exclusion 
criteria will include personal history of breast cancer. 

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5.2.5 Remuneration 
Clinics will be offered compensation for the administrative time and effort and IT efforts necessary to participate 
in the study. Organizations enrolling one clinic will be offered $4,000, organizations enrolling two clinics will be 
offered $6,000, and organizations enrolling three clinics will be offered $7,000. 
5.2.6 Data Collection Methods 
Data collection will be performed preferentially through clinic electronic health records. Data will be extracted 
from the electronic health records through automated reports and through manual chart review. Manual chart 
review will be performed by individuals affiliated only with the clinic site that the chart is being reviewed for. 
Individuals will have appropriate data access credentials and IRB approval. VUMC personnel will not directly 
access any medical records. Data extracted by chart review will be de-identified and entered into the Clinic Data 
Collection Form – REDCap. 
If an enrolled clinic does not have a reliable electronic health record, paper data collection forms or via REDCap 
will be used [Clinic Data Collection Form – Paper, Clinic Data Collection Form - REDCap]. These clinic data 
collection forms will be distributed to clinic sites by the research team prior to the initiation of the stepped-wedge 
trial. Research team personnel will provide instruction to clinic site personnel on how to use the forms. Clinic 
sites will store the data collection forms in a secure pre-determined location within the clinic. Forms will be 
electronically scanned and sent to the research team or collected by the research team bi-weekly. 
Data collected will include the date of the patient encounter, provider name, demographic information (age, 
race/ethnicity); was breast cancer RA offered/performed with the Tyrer-Cuzick tool? (yes/no), result of breast 
cancer RA, was further testing was recommended? (y/n), and what further testing was recommended on the 
clinical data collection forms. For clinics with reliable electronic health records, this information will be obtained 
from the electronic health record by participating clinics, deidentified, and provided to the Vanderbilt team. We 
will obtain data use agreements with the enrolled clinics for the data transfer. 
The numerator for the primary outcome (number of women receiving breast cancer RA by Tyrer-Cuzick model) 
will be extracted by study team members from the electronic health record or data collection form. Study team 
members will establish the denominator for the primary outcome (number of patients eligible for breast cancer 
RA) by extracting data on the number of eligible women seen for medical visits at each clinic site from the clinic’s 
electronic medical record or scheduling database.  
Data collection for secondary outcomes will include the number of women offered RA, but declining; number of 
high-risk women identified; number of high-risk women pursuing risk-stratified screening; number of abnormal 
screening studies; number of cancers identified; and types of cancers identified. Data on these secondary 
outcomes will be obtained from the electronic health record.  This data will be collected for 6 months following 
the completion of the stepped wedge trial. 
Additional secondary outcomes of adoption and maintenance will be extracted from the electronic health record 
or data collection forms (described in section 5.2.6) by Vanderbilt research team members. Adoption outcomes 
will include the total number of clinics offering RA and the total number of providers offering RA during the 
implementation phase. Maintenance outcomes will include the total number of clinics offering RA and the total 
number of providers offering RA six months after the completion of the implementation period.  
Data will be collected during the control, implementation, and maintenance time periods of the stepped-wedge 
trial. 
5.2.7 Consent  
As enrollment will occur at the clinic level, rather than the individual level, and the study intervention is considered 
usual care, consent from individual participants will not be obtained. We will use a data use agreement to obtain 
data from the electronic health record and the clinic data collection forms from the enrolled clinics.   
5.2.8 Data Analysis 
Data will be summarized using mean +/- standard deviation. Generalized linear mixed models for binary outcome 
will be used to assess difference in the proportion of participants receiving breast cancer RA between control 
and intervention groups, stratifying by clinic size, rural vs. urban location, race/ethnicity, socioeconomic status, 
and time, with a nested random-effect for subjects within clinic clusters. Adjusted odds ratio (OR) with 95% 

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confidence interval (CI) will be reported. Interaction between intervention and time will be assessed. All tests of 
statistical significance will be two-sided. Findings will be considered significant if p<0.05.  
5.3 Acceptability and Appropriateness  
5.3.1 Purpose 
Assess acceptability and appropriateness with an integrated mixed-methods analysis including surveys and 
interviews of patients and healthcare team members recruited from the 10 clinic sites enrolled in the stepped-
wedge trial.   
5.3.2 Healthcare Team Survey 
Healthcare Team Survey: During the maintenance phase of the stepped-wedge trial, we will distribute a web-
based REDCap survey via email to providers, staff, and administrators in the enrolled clinics to obtain data on 
acceptability, appropriateness, and intent to continue using the breast cancer RA tool. We will use adapted 
versions of the Acceptability of Intervention Measurement (AIM) and the Intervention Appropriateness Measure 
(IAM) scales. Up to 4 weekly email reminders will be sent weekly to non-responders to increase response rate.  
[see REDCap survey – Approp, Accept] 
Recruitment and Eligibility: The Vanderbilt team will perform recruitment for the Healthcare Team Survey via 
email with the guidance of the clinic site champions [see Recruitment Email – Survey]. The Vanderbilt team 
will respond via email or phone to answer additional questions potential survey respondents may have. The 
survey sample will consist of approximately 10 individuals per clinic (N = 100). Sample size at individual clinics 
may vary due to differences in the number of providers and staff at each clinic. Eligible individuals will be age 18 
and older and will be a provider, staff, or administrator employed in a clinic enrolled in the study. 
Data Collection Methods: Data will be collected and stored via REDCap, a secure online data collection tool. 
Consent: We will request a Waiver of Documented Consent for the Healthcare Team Survey.  Consent will be 
implied by completion of the survey. Participants will be provided with study information at the beginning of the 
survey. 
5.3.3 Healthcare Team Interviews  
Healthcare Team Interview: We will conduct semi-structured interviews during the maintenance phase with key 
informants. Interview guides will explore in more detail the results of the provider survey. We will elicit information 
about the acceptability and appropriateness of implementing our selected breast cancer RA strategies [see 
Interview Guide – Healthcare Team]. These interviews may be performed via telephone. Interviews are 
anticipated to last approximately 45-60 minutes. 
Recruitment and Eligibility: The Vanderbilt team will recruit Healthcare Team members from the enrolled clinics 
with the guidance of the site champion for interviews via email, phone, or in person [see Recruitment Email - 
Interview, Recruitment Script –Interview, Interview – Information Sheet]. The Vanderbilt team will recruit 
approximately 5 key informants per clinic (N=50) including individuals such as administrators, site champions 
and clinic providers (i.e. nurses and physicians). Site champions will help to identify participants for the 
Healthcare Team Interviews. Recruitment will stop when the team feels that we have reached data thematic 
saturation. Participants in these interviews may have complicated the Healthcare Team Survey, but that will not 
be a requirement. Eligible individuals will be age 18 and older and will be a provider, staff, or administrator 
employed in a clinic enrolled in the study. 
Remuneration: Healthcare team members participating in interviews will be offered a $50 incentive in 
appreciation of their time.  
Data Collection Methods: Interviews will be digitally recorded via audio recorders with participant permission, 
transcribed verbatim, and coded by two research team members using a codebook. If participants choose not to 
be recorded, the interviewer will take notes on their responses. Any identifying information that are part of the 
participants response will be removed from the transcriptions.  Original interview recordings will be destroyed 
once transcribed. The responses to all the interviews will be summarized.  When the specific responses from 
individual organizations are quoted, the organization or person’s name will not be identified. 

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Consent: We will request a Waiver of Documented Consent for the Healthcare Team Interviews. Consent will be 
implied by participation in the interview. Written consent will not be obtained. Interview participants will be 
provided with a study information sheet. [Interview – Information Sheet] 
5.3.4 Patient Interviews 
Patient Interview: We will conduct semi-structured interviews with patients who recently had breast cancer RA. 
Site champions will help to identify appropriate patient participants. These interviews will help us to understand 
the patient perspective on breast cancer RA. [see Interview Guide – Patient]. These interviews may be 
performed via telephone, in person, or via computer. Interviews are anticipated to last one hour or less. 
Recruitment and Eligibility: Clinic sites will identify potential participants for interviews via telephone, email, or in 
person [see Patient Interview - Recruitment Email (for clinic), Patient Interview - Recruitment Script (for 
clinic)]. Clinic staff will identify these potential participants through their own electronic health record or word of 
mouth. Clinical staff will ask potential patient participants if they 1) prefer to provide their contact information so 
the Vanderbilt team can contact them directly or 2) if they prefer to contact the Vanderbilt team themselves. At 
the participant’s preference, the clinic sites will either 1) obtain patient’s preferred method of contact (phone call 
[with an introductory text message] or email) and contact information or 2) provide contact information for the 
study team to patients. 
 
The Vanderbilt research team will store this participant contact information (name, email address, phone 
number) in a password protected file on an institutional secure server such as OneDrive. This information will 
not be connected in any way to participant interview data.  This information will be destroyed at the earliest 
time possible [see Patient Interview - Contact Information Form]. Once the participant and the Vanderbilt 
team are connected, the team will share more information about the study and enroll those who are interested. 
   
For patients preferring a phone call, a text message will be sent prior to the phone call to familiarize the 
participant with the phone number of the caller [see Patient Interview - initial text message before 
recruitment phone call]. If the Vanderbilt research team member calls the patient’s phone and does not reach 
the patient, the research team member will leave a voice mail [see Patient Interview - voicemail before 
recruitment script]. When the research team member reaches the patient on the phone, they will describe the 
study [see Patient Interview - Recruitment Script (for research team)]. For patients preferring an email, an 
email will be sent [see Patient Interview – Recruitment Email (research team)].  
  
The Vanderbilt research team member will discuss the study with the patient by email or phone call. If the patient 
agrees to participate in the interview, the Vanderbilt research team member will schedule the interview and then 
send the patient the Patient Information Sheet via email or text message [see Interview - Information Sheet, 
see Patient Interview - Provision of patient study information sheet via email or text message]. The day 
before and the day of the interview, the Vanderbilt research team member will send the patient a reminder text 
message or email about the interview [see Patient Interview - reminder text message or email].  
 
We will recruit approximately 50 patients for interviews. Recruitment will stop when the team feels that we have 
reached data thematic saturation. Eligible individuals will be women who were age 25-49 and had breast cancer 
RA performed at a clinic site that was enrolled in the BRAVE study during the study time period. 
 
Remuneration: Patients participating in interviews will be offered a $50 incentive in appreciation of their time.  In 
order to provide remuneration, the research study team will collect the patient’s preferred method of receiving 
remuneration (email, standard mail). The Vanderbilt research team will store this participant contact information 
(name, email address, mailing address phone number) in the password protected file described above on an 
institutional secure server such as OneDrive. This information will not be connected in any way to participant 
interview data.  This information will be destroyed at the earliest time possible. 
Data Collection Methods: Interviews will be digitally recorded via audio recorders with participant permission, 
transcribed verbatim, and coded by two research team members using a codebook. If participants choose not to 

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be recorded, the interviewer will take notes on their responses. Any identifying information that are part of the 
participants response will be removed from the transcriptions.  Original interview recordings will be destroyed 
once transcribed. The responses to all the interviews will be summarized.  When the specific responses from 
individual organizations are quoted, the organization or person’s name will not be identified. 
Consent: We will request a Waiver of Documented Consent for the Patient Interviews. Consent will be implied 
by participation in the interview. Written consent will not be obtained. Interview participants will be provided with 
a study information sheet. [see Interview - Information Sheet] 
5.3.5 Data Analysis 
We will use descriptive statistics to examine quantitative outcomes of reach, acceptability, and appropriateness. 
Continuous measurement will be summarized using mean + standard deviation or median and interquartile 
range. The AIM and IAM scores with 95% confidence intervals will be calculated. Summary tables and graphs 
will be created to describe and visualize the data.  Qualitative data will be analyzed using inductive coding to 
identify emerging themes.  
 
6. Total Recruitment 
6.1 Feasibility 
The Vanderbilt team will recruit approximately 60 participants from healthcare clinics across the state of 
Tennessee to participate in the Feasibility Assessment.  Recruitment of clinics to participate in this assessment 
will occur via email through established local connections. Eligible individuals will be age 18 and older and 
employed in a healthcare clinic providing breast care services in the state of Tennessee. 
6.2 Reach 
The Vanderbilt team will recruit and enroll a total of 10 healthcare clinics across the state of Tennessee to 
participate and will collect data on reach and clinical outcomes. Recruitment will occur via email and via personal 
contact using established local connections. Individual women will NOT be enrolled in the study or consented as 
the study intervention is considered usual care. At the clinics enrolled in the study, we will collect data from 
individual health records on women patients who are seen by the clinic. We anticipate that we will collect clinical 
data on approximately 3,000 individual women ages 18-49 during the time of the stepped-wedge trial. We will 
obtain a HIPAA waiver to collect data from the electronic medical record. 
6.3 Acceptability and Appropriateness 
Healthcare Team Survey: The Vanderbilt team will recruit approximately 100 individuals from the 10 clinic sites 
enrolled to complete the Healthcare Team survey. Eligible individuals will be age 18 and older and will be a 
provider, staff, or administrator employed in a clinic enrolled in the study.  
Healthcare Team Interview: The Vanderbilt team will recruit approximately 50 individuals to participate in 
Healthcare Team Interviews. These individuals may have completed the Healthcare Team Survey, but this will 
not be a requirement. Eligible individuals will be age 18 and older and will be a provider, staff, or administrator 
employed in a clinic enrolled in the study. Participants will be offered $50 remuneration for participation. 
Patient Interview: The Vanderbilt team will recruit approximately 50 individuals to participate in a Patient 
Interview. Eligible individuals will be women who were age 25-49 and had breast cancer RA performed at a clinic 
site enrolled in the BRAVE study during the study time period. Participants will be offered $50 remuneration for 
participation. 
 
7. Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or Others 
 
There are no greater than minimal risks anticipated for participating in this study. Breast cancer RA is considered 
usual care as a clinical offering.  
Participants completing surveys and interviews could potentially face minimal discomfort answering questions.  
Participants have the option of not answering any questions that make them feel uncomfortable and are free to 
end their participation at any time.  Participants will also be provided with a study information sheet explaining 

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the study and be given the contact information for the study PI and IRB so they may reach out with questions at 
any time. 
The minimal risk of participating in this study is outweighed by the potential benefit. The information gathered 
through the study will collectively help to identify the challenges, gaps, and opportunities for providers and 
patients regarding use of breast cancer risk assessment tools. This information gathered will also help to test 
the implementation of breast cancer risk assessment tools. 
No adverse events are anticipated for this study. Although no adverse events are anticipated for this study, the 
PI will report any adverse events to the IRB immediately.  
 
8. Study Withdrawal/Discontinuation 
 
Participants (including clinic sites) are free to stop participating at any time without penalty. Participants in 
surveys and interviews may choose not to answer any questions that make them feel uncomfortable.  
 
9. Privacy/Confidentiality Issues/Data Safety Monitoring 
 
There will be no hard copy signed consent forms for the surveys or interviews since a Waiver of Documentation 
of Consent will be requested and consent to participate will be implied by completing the survey or participating 
in the interview. Participants will be provided with study information. 
Data from the electronic surveys will be stored in REDCap, a secure online platform.  Deidentified, anonymous 
data downloaded from REDCap will be stored electronically in password protected VUMC Box folders. 
The feasibility listening sessions and acceptability/appropriateness interviews will be recorded with digital audio 
recorders with participant permission.  Recordings will be transcribed, and all identifiers will be removed from 
the transcription and notes. The responses to all the listening sessions and interviews will be summarized. When 
specific responses from individual organizations are quoted, the organization or person's name will not be 
identified. The recordings will be stored on password protected computers until they are transcribed, with access 
only available to study personnel. After the information is transcribed, the recording will be deleted.  
Electronic data abstracted from clinic electronic medical records and the clinic data forms will be stored in 
password protected Box folders or within REDCap. Data will be deidentified at the earliest time possible. Any 
data on paper forms will be stored in a locked cabinet in a locked office at VUMC. 
Contact information for the patient interviews will be stored in a password protected file on a secure server.  This 
information will be destroyed at the earliest time possible. 
Only study team personnel will have access to the data. 
We will obtain a data use agreement with each enrolled clinic to obtain clinical data. 
 
10. Follow-up and Record Retention 
 
We will maintain the electronic data files on a password protected computer and paper data files in locked 
cabinets in locked offices, with access available to study personnel only.  We will maintain the files for at least 
six years after the research is completed.