BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Study Overview
=================
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.

Official Title
-----------------
BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Intervention plus 12 months maintenance
* Other: Intervention plus 10 months maintenance
* Other: Intervention plus 8 months maintenance
* Other: Intervention plus 6 months maintenance
* Other: Intervention plus 4 months maintenance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 25-49 Exclusion Criteria: personal history of breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention plus 12 months maintenance<br>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<br>* 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.<br>|
| Experimental: Intervention plus 10 months maintenance<br>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<br>* 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.<br>|
| Experimental: Intervention plus 8 months maintenance<br>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<br>* 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.<br>|
| Experimental: Intervention plus 6 months maintenance<br>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<br>* 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.<br>|
| Experimental: Intervention plus 4 months maintenance<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, mammogram, screening, risk assessment