PREDICTORS OF ADJUVANT ENDOCRINE THERAPY ADHERENCE IN WOMEN WITH BREAST CANCER

乳腺癌女性辅助内分泌治疗依从性的预测因素

• 批准号: 8465139
• 负责人: VANESSA B SHEPPARD
• 金额: $ 48.56万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8465139
• 关键词: Accounting; Adherence; Adjuvant; Adult; Adverse effects; Affect; Area; BRCA1 gene; Behavior Therapy; Blood; CYP2D6 gene; Cancer Etiology; Cancer Patient; Clinical; Clinical Data; Cohort Studies; Communication; Comorbidity; Computerized Medical Record; DNA; Data; Electronics; Equilibrium; Genetic Polymorphism; Genomics; Goals; Healthcare; Hormonal; Hormone Receptor; Intervention; Interview; Knowledge; Length; Link; Malignant Neoplasms; Mediating; Metabolism; Modeling; Monitor; Outcome; Patient Noncompliance; Patients; Pharmacogenetics; Pharmacy facility; Provider; Psychosocial Factor; Race; Records; Recurrence; Research; Research Personnel; Risk; Role; Sampling; Staging; Subgroup; Swab; Tamoxifen; Testing; Therapeutic; Time; Variant; Woman; abstracting; anastrozole; cancer care; cancer diagnosis; clinical care; clinical practice; cohort; coping; ethnic difference; follow-up; health care delivery; health care service utilization; hormone therapy; improved; malignant breast neoplasm; mortality; prospective; psychosocial; racial difference; receptor; research study; screening; therapy adherence; tumor; uptake

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.

描述（由申请人提供）：辅助荷尔蒙治疗是激素受体阳性乳腺癌常规癌症护理的关键部分；将复发和死亡率分别降低26％和50％。但是，遵守激素疗法已被确定为低至50％的重大问题。这种不遵守与结果不佳有关。关于解释患者不遵守原因的原因的因素知之甚少，因为大多数研究都没有前瞻性收集有关医疗保健提供或社会心理因素的详细数据。我们组建了一个杰出的调查人员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，这些乳腺癌启动治疗并关注它们三年。我们将使用电子药房数据来捕获女性在停止治疗之前继续进行治疗的时间。经过基线访谈，我们将在12、24和36个月进行后续采访，以捕捉副作用的变化和新的合并症的出现。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。研究目的是：1）评估依从性临床，医疗保健提供和社会心理预测因素的贡献； 2）确定在AIM 1中确定的预测因素是否中等和/或介导种族与依从性之间的关系。在探索性目的中，我们将评估CYP2D6多态性是否与他莫昔芬女性的副作用有关，如果是的，请确定未来研究的效果大小估计值。我们还将探讨样本提供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有关黑人和白人妇女辅助荷尔蒙治疗原因的知识的空白。数据将用于为临床实践中的荷尔蒙治疗提供信息，确定最有依从性风险的患者的亚组，并发展行为干预措施。结果将广泛地运输到荷尔蒙受体阳性乳腺癌的女性，这些乳腺癌占大多数乳腺癌病例。