BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

NCT ID: NCT05051631

Last Updated: 2025-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1071 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stepped-Wedge Trial. 10 clinics will be assigned to 5 arms to receive the intervention at sequential times. The time at which each arm receives the intervention will be randomized.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention plus 12 months maintenance

Intervention Type 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

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.

Group Type EXPERIMENTAL

Intervention plus 10 months maintenance

Intervention Type 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

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.

Group Type EXPERIMENTAL

Intervention plus 8 months maintenance

Intervention Type 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

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.

Group Type EXPERIMENTAL

Intervention plus 6 months maintenance

Intervention Type 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

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.

Group Type EXPERIMENTAL

Intervention plus 4 months maintenance

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ages 25-49

Exclusion Criteria

* personal history of breast cancer
Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Lucy Spalluto

Associate Professor of Radiology and Radiological Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucy B Spalluto, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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211753

Identifier Type: -

Identifier Source: org_study_id

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