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。 公共卫生相关性：荷尔蒙受体阳性乳腺癌患者接受激素辅助治疗的生存益处是有据可查的。然而，在所有开始激素治疗的乳腺癌患者中，有一半在第五年前停止治疗。研究表明，不坚持治疗会显著增加乳腺癌患者的死亡率。尽管它很重要，但人们对解释为什么这么多女性未能完成治疗的因素知之甚少。在这项研究中，开始激素治疗的女性将接受为期3年的治疗，以确定预测其依从性的临床、心理和医疗保健提供因素。由于对激素治疗依从性的种族差异知之甚少，我们将检查黑人和白人女性的预测因素是否相似。我们还将探讨药物遗传因素和副作用的影响。研究结果将被用来确定最有可能停止治疗的妇女，并开发干预措施，帮助妇女继续接受治疗。

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. PUBLIC HEALTH RELEVANCE: The survival benefits of adjuvant hormonal therapy for women with hormonal receptor positive breast cancers are well documented. However, half of all breast cancer patients who start hormonal therapy discontinue treatment by the fifth year. Non-adherence to therapy has been shown to significantly increase mortality in breast cancer patients. Despite its importance, little is known about factors that explain why so many women fail to complete therapy. In this study, women who start hormonal therapy will be followed for 3 years of treatment to identify clinical, psychosocial, and healthcare delivery factors that predict their adherence. Because little information is known about ethnic differences in adherence to hormonal therapy, we will examine whether the predictors are similar in Black and White women. We will also explore the influence of pharmacogenetic factors and side effects. Study findings will be used to identify women most at risk for stopping treatment and to develop interventions to help women remain on therapy.