Vanderbilt Clinical Trials

BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Purpose

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.

Condition

Breast Cancer

Eligibility

Eligible Ages: Between 25 Years and 49 Years
Eligible Genders: Female
Accepts Healthy Volunteers: Yes

Inclusion Criteria

ages 25-49

Exclusion Criteria

personal history of breast cancer

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 Purpose: Screening
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Contact:
Lucy B Spalluto, MD MPH
615-322-1585
lucy.b.spalluto@vumc.org

More Details

Status: Recruiting
Sponsor: Vanderbilt University Medical Center

Study Contact

Lucy B Spalluto, MD MPH
615-322-1585
lucy.b.spalluto@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.