BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Vanderbilt University Medical Center

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Intervention plus 10 months maintenance; Other: Intervention plus 8 months maintenance; Other: Intervention plus 6 months maintenance; Other: Intervention plus 4 months maintenance; Other: Intervention plus 12 months maintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT05051631

211753

Details and patient eligibility

About

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.

Enrollment: 1,071 patients

Sex: Female

Ages: 25 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ages 25-49

Exclusion criteria

• personal history of breast cancer

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,071 participants in 5 patient groups

Intervention plus 12 months maintenance

Experimental group

Description:

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.

Treatment:

Other: Intervention plus 12 months maintenance

Intervention plus 10 months maintenance

Experimental group

Description:

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.

Treatment:

Other: Intervention plus 10 months maintenance

Intervention plus 8 months maintenance

Experimental group

Description:

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.

Treatment:

Other: Intervention plus 8 months maintenance

Intervention plus 6 months maintenance

Experimental group

Description:

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.

Treatment:

Other: Intervention plus 6 months maintenance

Intervention plus 4 months maintenance

Experimental group

Description:

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.

Treatment:

Other: Intervention plus 4 months maintenance