NCT05051631

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,071 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: Female
• Age: 25 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Intervention plus 12 months maintenance	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.
OTHER	Intervention plus 10 months maintenance	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.
OTHER	Intervention plus 8 months maintenance	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.
OTHER	Intervention plus 6 months maintenance	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.
OTHER	Intervention plus 4 months maintenance	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.

Timeline

• Start date: 2022-03-09
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2021-09-21
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

1 site across 1 country: United States