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

描述（由申请人提供）：接受过胸部放射治疗儿童癌症的妇女通常有多种健康问题，并且在年轻时（四十岁之前）患乳腺癌的风险显着增加。虽然建议从25岁开始每年进行乳房x光检查和辅助乳房核磁共振检查，但大多数年轻女性并没有接受筛查。我们已经进行了初步研究，以确定筛查的重要预测因素，并成功地试点了一项干预措施，从而提高了这一高危人群的乳腺癌筛查率。为了降低儿童期癌症幸存者面临的乳腺癌相关发病率和死亡率，有必要对旨在促进乳腺癌监测的基于行为的干预研究进行正式测试。在提议的为期12个月的干预试验中，330名年龄在25岁至39岁之间，在过去两年内没有做过乳房x光检查（或类似的筛查成像研究）的女性，我们将测试旨在提高成功完成推荐监测可能性的干预的有效性。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，包括邮寄的量身定制的教育干预，然后是通过电话进行的基于阶段的简短动机访谈。主要结果是在12个月的研究期间获得乳房x光检查，并由医疗记录证实。我们假设随机分配到干预组的女性比随机分配到注意控制组的女性乳房x光筛查率高20%。次要目标将包括探索预测乳房x光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的妇女的百分比，并探索完成该成像测试的障碍（例如，保险/成本，医生授权），并估计干预复制成本和干预导致的成本。拟议的EMPOWER（鼓励乳房x线摄影/核磁共振成像和辐射暴露妇女的预防机会）研究汇集了一个研究团队，他们在幸存者研究和电话动机访谈方面具有必要的专业知识和经验，并利用26家机构儿童癌症幸存者研究（CCSS）的独特资源。值得注意的是，社会保障制度是目标人口中最大的妇女群体，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接受胸部放射治疗的儿童癌症妇女乳腺癌监测的随机对照试验，并将促进我们对这一弱势群体的了解。

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.