EMPOWER Study: Promoting BC Screening in Women Who Survived Childhood Cancer

描述(申请人提供)：因儿童癌症接受过胸部放射治疗的妇女经常有多种健康问题，并在年轻时(40多岁之前)患乳腺癌的风险显著增加。尽管建议从25岁开始每年进行乳房X光检查和辅助乳房核磁共振检查，但大多数年轻女性都没有接受筛查。我们已经进行了初步研究，以确定筛查的重要预测因素，并成功地试行了一项干预措施，在这一高危人群中提高了乳腺癌筛查率。为了减少儿童癌症幸存者面临的乳腺癌相关发病率和死亡率，必须正式测试旨在促进乳腺癌监测的以行为为基础的干预研究。在拟议的为期12个月的干预试验中，我们将在330名年龄在25岁至39岁之间且在过去两年内没有进行过乳房X光检查(或类似的筛查成像研究)的妇女中，测试旨在增加成功完成建议监测的可能性的干预措施的有效性。这种干预在理论上建立在跨理论模型和健康信念模型的基础上，包括邮寄的量身定做的教育干预，然后通过电话进行基于阶段的简短动机访谈。主要结果是在12个月的研究期间进行了乳房X光检查，这一结果得到了医疗记录的证实。我们假设随机进入干预组的女性将比随机进入注意力控制组的女性筛查乳房X光检查的比率高出20%。次要目标将包括探索预测乳房X光检查完成率和获得监测的时间的调节和中介因素，确定获得辅助乳房MRI的妇女的百分比，探索完成这一成像测试的障碍(例如，保险/费用、医生授权)，以及估计干预复制成本和干预产生的成本。拟议的EMPOWER(鼓励乳房摄影/核磁共振和辐射暴露妇女的预防性机会)研究汇集了一个研究小组，他们在生存研究和电话采访方面拥有必要的专业知识和经验，并利用由26个机构组成的儿童癌症幸存者研究(CCSS)的独特资源进行了采访。值得注意的是，CCSS是目标人群中最大的单一妇女队列，也是进行拟议研究的基础设施。这项研究将是第一个旨在促进对接受胸部放射治疗的儿童癌症女性进行乳腺癌监测的随机对照试验，并将增进我们对这一脆弱群体的了解。

DESCRIPTION (provided by applicant): Women who have been treated with chest radiation for a childhood cancer frequently have multiple health problems and have a significantly increased risk of developing breast cancer at a young age (prior to their forties). Although breast cancer surveillance with annual mammography and adjunct breast MRI is recommended starting at age 25, most young women are not obtaining screening. We have conducted preliminary studies to identify important predictors of screening and successfully piloted an intervention leading to increased rates of breast cancer screening among this high risk population. To reduce the breast cancer related morbidity and mortality faced by women who survived childhood cancer, it is imperative to formally test behaviorally-based intervention studies intended to promote breast cancer surveillance. In the proposed 12-month intervention trial, among 330 women who are 25 to 39 years of age and who have not had a mammogram (or similar screening imaging study) in the preceding two years, we will test the efficacy of an intervention aimed at increasing the likelihood of successfully completing the recommended surveillance. The intervention, theoretically founded upon the Transtheoretical Model and the Health Belief Model, consists of a mailed tailored education intervention followed by a stage-based brief motivational interview delivered by telephone. The primary outcome is obtaining a mammogram during the 12-month study period, confirmed by medical record. We hypothesize that women randomized to the intervention group will have a 20% higher rate of screening mammography than women randomized to the attention control group. Secondary aims will include exploring moderating and mediating factors that predict mammogram completion and timing of the obtained surveillance, determining the percent of women who obtain an adjunct breast MRI and explore barriers to completing this imaging test (e.g., insurance/cost, physician authorization), and estimating the intervention replication costs and costs resulting from the intervention. The proposed EMPOWER (Encouraging Mammography/MRI and Preventive Opportunities for Women Exposed to Radiation) study brings together a research team with the necessary expertise and experience in both survivorship research and telephone delivered motivational interviewing with the unique resource of the 26-institution Childhood Cancer Survivor Study (CCSS). Notably, the CCSS represents the single largest cohort of women in the target population and the infrastructure to conduct the proposed study. This study will represent the first randomized controlled trial aimed at promoting breast cancer surveillance among women who are treated with chest radiation for a childhood cancer and will advance our understanding of this vulnerable group.