BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

NCT05051631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1071

Last updated 2025-08-28

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Lucy B Spalluto, MD MPH · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05051631 on ClinicalTrials.gov