BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- ages 25-49
Exclusion Criteria:
- personal history of breast cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt University Medical Center
Investigators
- Principal Investigator: Lucy B Spalluto, MD MPH, Vanderbilt University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 211753