BRAVE Strategy - Breast Cancer Risk Assessment -achieVing Equity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,071
- 试验地点
- 1
- 主要终点
- Number of Eligible Women Who Received Breast Cancer Risk Assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ages 25-49
排除标准
- •personal history of breast cancer
研究组 & 干预措施
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.
干预措施: Intervention plus 12 months maintenance (Other)
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.
干预措施: Intervention plus 10 months maintenance (Other)
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.
干预措施: Intervention plus 8 months maintenance (Other)
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.
干预措施: Intervention plus 6 months maintenance (Other)
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.
干预措施: Intervention plus 4 months maintenance (Other)
结局指标
主要结局
Number of Eligible Women Who Received Breast Cancer Risk Assessment
时间窗: Baseline (2-months prior to intervention) to 9 months post-intervention
The number of women eligible for risk assessment who received documented breast cancer risk assessment.
次要结局
- Number of Cancers Detected in Women Identified at High Risk.(Baseline (2-months prior to intervention) to 9 months post-intervention)
- Number of Women Who Received Risk Assessment Who Were Identified as High Risk for Breast Cancer.(Baseline (2-months prior to intervention) to 9 months post-intervention)
- Number of Women Identified as High Risk Women Who Received Breast Cancer Screening.(Baseline (2-months prior to intervention) to 9 months post-intervention)
研究者
Lucy Spalluto
Associate Professor of Radiology and Radiological Sciences
Vanderbilt University Medical Center