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Clinical Trials/NCT05051631
NCT05051631
Completed
Not Applicable

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Vanderbilt University Medical Center1 site in 1 country1,071 target enrollmentMarch 9, 2022
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Vanderbilt University Medical Center
Enrollment
1071
Locations
1
Primary Endpoint
Number of Eligible Women Who Received Breast Cancer Risk Assessment
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2022
End Date
August 30, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lucy Spalluto

Associate Professor of Radiology and Radiological Sciences

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • ages 25-49

Exclusion Criteria

  • personal history of breast cancer

Outcomes

Primary Outcomes

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

  • Number of Cancers Detected in Women Identified at High Risk.(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.(Baseline (2-months prior to intervention) to 9 months post-intervention)
  • Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.(Baseline (2-months prior to intervention) to 9 months post-intervention)

Study Sites (1)

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