PREDICTORS OF ADJUVANT ENDOCRINE THERAPY ADHERENCE IN WOMEN WITH BREAST CANCER

描述(申请人提供)：辅助激素治疗是荷尔蒙受体阳性乳腺癌常规癌症护理的关键部分；将复发率和死亡率分别降低26%和50%。然而，坚持激素治疗已被确定为一个严重的问题，发病率低至50%。这种不遵守被认为与糟糕的结果有关。由于大多数研究没有前瞻性地收集关于医疗保健提供或心理社会因素的详细数据，因此对解释患者不遵守的原因的因素知之甚少。我们已经组建了一支出色的调查团队来填补这些空白。这项研究的总体目标是为降低潜在的可避免的乳腺癌死亡率做出贡献。在依从性模型的指导下，我们将对900名荷尔蒙阳性乳腺癌的黑人和白人妇女进行纵向前瞻性队列研究，她们开始治疗并跟踪治疗三年。我们将使用电子药房数据来记录女性在停止治疗之前继续接受治疗的时间。在基线访谈后，我们将在12个月、24个月和36个月进行后续访谈，以捕捉副作用的变化和新的并发症的出现。来自患者访谈的详细数据将与电子病历和医疗保健利用数据合并。研究的目的是：1)评估临床、医疗保健和心理社会预测因素对坚持的贡献；2)确定目标1中确定的预测因素是否在种族和坚持之间存在中等和/或中介关系。在一个探索性的目的中，我们将评估CYP2D6基因多态是否与服用他莫昔芬的女性患者的副作用有关，如果是，则为未来的研究确定效应大小估计。我们还将探讨样本规定中是否存在可能影响结论的种族差异。这项研究的结果有可能填补关于黑人和白人女性不坚持辅助性激素治疗的原因的知识空白。数据将用于在临床实践中提供激素治疗的信息，识别最有可能出现不遵守治疗的患者亚群，并开发行为干预措施。结果将广泛传播到荷尔蒙受体阳性乳腺癌患者中，这些患者占乳腺癌病例的大多数。

DESCRIPTION (provided by applicant): Adjuvant hormonal therapy is a critical part of routine cancer care for hormonal receptor positive breast cancers; reducing recurrence and mortality by 26 percent and 50 percent, respectively. However, adherence to hormonal therapy has been identified as a significant problem with rates as low as 50 percent. Such non-adherence has been linked to poor outcomes. Little is known about factors that explain reasons for patients' non-adherence since most studies have not prospectively collected detailed data regarding healthcare delivery or psychosocial factors. We have assembled an outstanding team of investigators to fill these gaps. The overall goal of this study is to contribute to the reduction of potential avoidable breast cancer mortality. Guided by the Adherence Model, we will conduct a longitudinal prospective cohort study of 900 Black and White women with hormonal positive breast cancer who initiate therapy and follow them for three years. We will use electronic pharmacy data to capture how long women remain on therapy before they stop treatment. After a baseline interview, we will conduct follow-up interviews at 12, 24, and 36 months to capture changes in side effects and the emergence of new co-morbidities. Detailed data from patient interviews will be merged with electronic medical records and healthcare utilization data. Study aims are to: 1) Evaluate the contribution of clinical, healthcare delivery and psychosocial predictors of adherence; and 2) Determine if predictors identified in Aim 1 moderate and/or mediate relationships between race and adherence. In an exploratory aim we will evaluate whether CYP2D6 polymorphisms are associated with side-effects among women on Tamoxifen, and if so, determine effect size estimates for future research. We will also explore if there are racial differences in sample provision that could affect conclusions. Results from this study have the potential to fill gaps in knowledge regarding reasons for non-adherence to adjuvant hormonal therapy in both Black and White women. Data will be used to inform delivery of hormonal therapy in clinical practice, identify subgroups of patients most at risk for non- adherence, and develop behavioral interventions. Results will be broadly transportable to women with hormonal receptor positive breast cancers which account for the majority of breast cancer cases.