BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
BRAVE
1 other identifier
interventional
1,071
1 country
1
Brief Summary
The central goal of this study is to test strategies to implement evidence-based breast cancer risk assessment in healthcare clinics in Tennessee. The BRAVE Strategy (Breast cancer Risk Assessment - achieVing Equity) study aims to assess the feasibility, reach, acceptability, and appropriateness of select customized strategies to increase uptake of breast cancer risk assessment. The investigators will achieve these aims through a conducting a stepped-wedge trial conducted in 10 healthcare clinics in the state of Tennessee. The primary outcome is the proportion of women age 25-49 having risk assessment. Secondary outcomes include the numbers of 1) women identified as high-risk; 2) pursuing risk-adherent screening; and 3) diagnosed with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
September 21, 2021
CompletedStudy Start
First participant enrolled
March 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedResults Posted
Study results publicly available
August 28, 2025
CompletedAugust 28, 2025
August 1, 2025
2.5 years
September 10, 2021
August 6, 2025
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Eligible Women Who Received Breast Cancer Risk Assessment
The number of women eligible for risk assessment who received documented breast cancer risk assessment.
Baseline (2-months prior to intervention) to 9 months post-intervention
Secondary Outcomes (3)
Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.
Baseline (2-months prior to intervention) to 9 months post-intervention
Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.
Baseline (2-months prior to intervention) to 9 months post-intervention
Number of Cancers Detected in Women Identified at High Risk.
Baseline (2-months prior to intervention) to 9 months post-intervention
Study Arms (5)
Intervention plus 12 months maintenance
EXPERIMENTALClinics in this group will be in the control phase for 2 months, receive the 4 month intervention, and be in the maintenance phase for 12 months.
Intervention plus 10 months maintenance
EXPERIMENTALClinics in this group will be in the control phase for 4 months, receive the 4 month intervention, and be in the maintenance phase for 10 months.
Intervention plus 8 months maintenance
EXPERIMENTALClinics in this group will be in the control phase for 6 months, receive the 4 month intervention, and be in the maintenance phase for 8 months.
Intervention plus 6 months maintenance
EXPERIMENTALClinics in this group will be in the control phase for 8 months, receive the 4 month intervention, and be in the maintenance phase for 6 months.
Intervention plus 4 months maintenance
EXPERIMENTALClinics in this group will be in the control phase for 10 months, receive the 4 month intervention, and be in the maintenance phase for 4 months.
Interventions
The intervention will include 2 months of data collection in the control period, 4 months of education and awareness training, and 12 months of data collection in the maintenance time period.
The intervention will include 4 months of data collection in the control period, 4 months of education and awareness training, and 10 months of data collection in the maintenance time period.
The intervention will include 6 months of data collection in the control period, 4 months of education and awareness training, and 8 months of data collection in the maintenance time period.
The intervention will include 8 months of data collection in the control period, 4 months of education and awareness training, and 6 months of data collection in the maintenance time period.
The intervention will include 10 months of data collection in the control period, 4 months of education and awareness training, and 4 months of data collection in the maintenance time period.
Eligibility Criteria
You may qualify if:
- ages 25-49
You may not qualify if:
- personal history of breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We had significant difficulty enrolling community clinics during this trial due to the impacts of the COVID 19 pandemic and resulting limitations in clinic resources. We enrolled a single clinic. This clinic was in Arm 1 - (2 months control, 4 months intervention,12 months maintenance). Due to clinic limited resources, we were also limited to 9 months of data collection in the maintenance time period, rather than the full 12 months.
Results Point of Contact
- Title
- Dr. Lucy Spalluto
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Lucy B Spalluto, MD MPH
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Radiology and Radiological Sciences
Study Record Dates
First Submitted
September 10, 2021
First Posted
September 21, 2021
Study Start
March 9, 2022
Primary Completion
August 30, 2024
Study Completion
August 30, 2024
Last Updated
August 28, 2025
Results First Posted
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share