BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
- Conditions
- Breast Cancer
- Interventions
- Other: Intervention plus 10 months maintenanceOther: Intervention plus 4 months maintenanceOther: Intervention plus 12 months maintenanceOther: Intervention plus 6 months maintenanceOther: Intervention plus 8 months maintenance
- Registration Number
- NCT05051631
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 500
- ages 25-49
- personal history of breast cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention plus 10 months maintenance 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. Intervention plus 4 months maintenance 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. Intervention plus 12 months maintenance 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. Intervention plus 6 months maintenance 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. Intervention plus 8 months maintenance 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.
- Primary Outcome Measures
Name Time Method Proportion of eligible women who receive breast cancer risk assessment baseline to 18 months Proportion will be measured as a binary outcome (yes/no received risk assessment)
- Secondary Outcome Measures
Name Time Method Number of high risk women who received screening baseline to 24 months Screening is defined as screening mammography or breast MRI. The number of women who received screening will be calculated from electronic health records.
Number of women identified as high risk for breast cancer baseline to 18 months Women with a 20% or greater lifetime risk of breast cancer using the Tyrer Cuzick risk assessment tool will be considered high risk. The Tyrer Cuzick risk assessment tool is an 11 question electronic risk assessment tool about a woman's family history of cancer and personal history to immediately calculate a lifetime risk percentage.
Number of cancers detected in high risk women baseline to 24 months Cancers will include invasive cancers and cancer in situ. Cancers will be identified from electronic health records.
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States