BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05051631
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 9, 2022
Status verified
Aug 2025
Primary completion
Aug 30, 2024
Completion
Aug 30, 2024

Study Design

Enrollment
1,071 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Number of Eligible Women Who Received Breast Cancer Risk Assessment [ Time Frame: Baseline (2-months prior to intervention) to 9 months post-intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Nashville, TN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Vanderbilt University Medical Center· Nashville, TN

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