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Completed

NCT Number: NCT05051631

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ages 25-49

Exclusion criteria

  • personal history of breast cancer

Treatment and study plan

Intervention plus 12 months maintenance

Other

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.

Intervention plus 10 months maintenance

Other

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.

Intervention plus 8 months maintenance

Other

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.

Intervention plus 6 months maintenance

Other

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.

Intervention plus 4 months maintenance

Other

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.

Primary outcomes

  1. Number of Eligible Women Who Received Breast Cancer Risk Assessment

    Time frame: 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 outcomes

  1. Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.

    Time frame: 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.

  2. Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.

    Time frame: 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.

  3. Number of Cancers Detected in Women Identified at High Risk.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: BRAVE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2021
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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