BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05051631
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Study Start: 2022-03-09
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-08
• Results First Submitted: 2025-08-06
• Results First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Results First Posted: 2025-08-28
• Last Update Posted: 2025-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1071

Inclusion Criteria

• ages 25-49

Exclusion Criteria

• personal history of breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Eligible Women Who Received Breast Cancer Risk Assessment	Baseline (2-months prior to intervention) to 9 months post-intervention	The number of women eligible for risk assessment who received documented breast cancer risk assessment.

Secondary Outcome Measures

Name	Time	Method
Number of Cancers Detected in Women Identified at High Risk.	Baseline (2-months prior to intervention) to 9 months post-intervention	Cancers will include invasive cancers and cancer in situ. Cancers will be identified from electronic health records. For this measure, the denominator includes only those who were identified as high risk.
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 who received risk assessment who were identified as high risk for breast cancer. Women are considered high risk if they have 20% or greater lifetime risk of breast cancer using the Tyrer Cuzick risk assessment tool. The Tyrer Cuzick risk assessment tool is an 11 question electronic risk assessment tool about a woman's family history of cancer and personal history to immediately calculate a lifetime risk percentage.
Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.	Baseline (2-months prior to intervention) to 9 months post-intervention	Screening is defined as screening mammography or breast MRI. The number of women who received screening will be identified through from electronic health record review. For this measure, the denominator includes only those who were identified as high risk.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States