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

描述（由申请人提供）：因儿童癌症接受胸部放射治疗的妇女经常有多种健康问题，并且在年轻时（40岁之前）患乳腺癌的风险显著增加。虽然建议从25岁开始每年进行乳房X光检查和辅助乳房MRI的乳腺癌监测，但大多数年轻妇女没有获得筛查。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，提高了这一高危人群的乳腺癌筛查率。为了降低儿童癌症幸存妇女所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基于行为的干预研究。在拟议的12个月干预试验中，在330名25至39岁的妇女中，在过去两年中没有进行乳房X光检查（或类似的筛查成像研究），我们将测试旨在增加成功完成推荐监测的可能性的干预措施的有效性。干预，理论上建立在跨理论模型和健康信念模型，包括一个邮寄量身定制的教育干预，然后通过电话提供一个基于阶段的简短的动机采访。主要结果是在12个月的研究期间获得乳房X光检查，并通过医疗记录确认。我们假设，随机分配到干预组的妇女将有20%的筛查乳腺X射线摄影比随机分配到注意力控制组的妇女高。次要目的将包括探索预测乳房X线检查完成和获得监测时间的调节和中介因素，确定获得辅助乳房MRI的女性百分比，并探索完成该成像测试的障碍（例如，保险/成本、医师授权），以及估计干预复制成本和由干预产生的成本。拟议的EMPOWER（鼓励乳腺X线摄影/MRI和预防暴露于辐射的妇女的机会）研究汇集了一个研究团队，该研究团队在生存研究和电话激励访谈方面具有必要的专业知识和经验，并拥有26个机构儿童癌症幸存者研究（CCSS）的独特资源。值得注意的是，哥斯达黎加社保局是目标人群中最大的一个妇女群体，也是开展拟议研究的基础设施。这项研究将代表第一个随机对照试验，旨在促进乳腺癌监测的妇女谁是胸部放射治疗的儿童癌症，并将促进我们对这一弱势群体的理解。

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.