EMPOWER Study: Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- efficacy
研究概览
简要总结
The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy.
The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Participant in the CCSS cohort
- •Diagnosed with a childhood cancer prior to 21 years of age
- •Treated with > 20 Gy of chest radiation (mantle, mediastinal, lung, or chest)
- •Age 25-49 years at time of enrollment into the study
- •Interval from chest radiation to the time of enrollment of > 8 years
- •No mammogram or other breast imaging study in the 24 months prior to enrollment
- •English-speaking - The University of Colorado AMC Denver and MSKCC group are not capable of or equipped for conducting a brief motivational interviews by telephone in another language.
排除标准
- •Diagnosed with breast cancer
- •Participated in the Project VISION feasibility study (exposed to part of the intervention)
研究组 & 干预措施
Intervention Group
The EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).
干预措施: survey, questionaire (Behavioral)
attention control group
The EMPOWER intervention trial is a 12-month study of 360 women from the Childhood Cancer Survivor Study who have previously been treated with chest radiation, are 25 to 49 years of age at the time of enrollment, are 8 years or more since their chest radiation, and have not had a mammogram or other breast imaging study in the preceding two years. Following a baseline questionnaire, participants will be randomized to the attention control group (N=120) or the intervention group (N=240).
干预措施: survey, questionaire (Behavioral)
结局指标
主要结局
efficacy
时间窗: 12 months
Determine the efficacy of an intervention, consisting of mailed tailored print materials followed by a telephone-delivered Brief Motivational Interview, on mammogram screening rates compared with an attention control. Mammogram completed by 12-month questionnaire (confirmed by medical record)
次要结局
- Economic analysis(12 months)
- Breast MRI completed by 12-month questionnaire(12 months)
- Moderating factors(12 months)
- Mediating factors(12 months)