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）：辅助激素治疗是激素受体阳性乳腺癌常规癌症护理的关键部分;分别将复发率和死亡率降低26%和50%。然而，坚持激素治疗已被确定为一个重大问题，其比率低至50%。这种不遵守与不良结果有关。由于大多数研究没有前瞻性地收集关于医疗服务或心理社会因素的详细数据，因此对解释患者不依从原因的因素知之甚少。我们已经组建了一个出色的调查小组来填补这些空白。这项研究的总体目标是有助于降低潜在的可避免的乳腺癌死亡率。在依从性模型的指导下，我们将对900名患有激素阳性乳腺癌的黑人和白色女性进行纵向前瞻性队列研究，这些女性开始治疗并随访三年。我们将使用电子药房数据来记录女性在停止治疗前持续治疗的时间。在基线访谈后，我们将在12个月、24个月和36个月进行随访访谈，以捕捉副作用的变化和新合并症的出现。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）评估临床、医疗服务和依从性的心理社会预测因素的贡献;以及2）确定目标1中确定的预测因素是否在种族和依从性之间具有中度和/或中介关系。在一个探索性的目的，我们将评估是否CYP 2D 6多态性与妇女对他莫昔芬的副作用，如果是这样，确定效应量估计为未来的研究。我们还将探讨样本提供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黑人和白色女性不依从辅助激素治疗原因的知识空白。数据将用于告知临床实践中激素治疗的交付，确定最有可能不依从的患者亚组，并制定行为干预措施。结果将广泛传播到女性激素受体阳性乳腺癌占大多数乳腺癌病例。