BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Breast Cancer Clinical Trial

— BRAVE  

Official title:

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051631
• Other study ID #: 211753
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: Lucy B Spalluto, MD MPH
• Phone: 615-322-1585
• Email: lucy.b.spalluto[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

Inclusion Criteria:

• ages 25-49

Exclusion Criteria:

• personal history of breast cancer

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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 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 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 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 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible women who receive breast cancer risk assessment	Proportion will be measured as a binary outcome (yes/no received risk assessment)	baseline to 18 months
Secondary	Number of women identified as high risk for breast cancer	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.	baseline to 18 months
Secondary	Number of high risk women who received screening	Screening is defined as screening mammography or breast MRI. The number of women who received screening will be calculated from electronic health records.	baseline to 24 months
Secondary	Number of cancers detected in high risk women	Cancers will include invasive cancers and cancer in situ. Cancers will be identified from electronic health records.	baseline to 24 months