BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity (BRAVE)

August 26, 2025 updated by: Lucy Spalluto, Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1071

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ages 25-49

Exclusion Criteria:

  • personal history of breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention plus 12 months maintenance
Clinics 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.
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.
Experimental: Intervention plus 10 months maintenance
Clinics 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.
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.
Experimental: Intervention plus 8 months maintenance
Clinics 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.
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.
Experimental: Intervention plus 6 months maintenance
Clinics 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.
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.
Experimental: Intervention plus 4 months maintenance
Clinics 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (2-months prior to intervention) to 9 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (2-months prior to intervention) to 9 months post-intervention
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.
Baseline (2-months prior to intervention) to 9 months post-intervention
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.
Baseline (2-months prior to intervention) to 9 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Lucy B Spalluto, MD MPH, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

September 10, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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