Long-term endocrine therapy adherence following stress management for breast cancer

乳腺癌压力管理后长期坚持内分泌治疗

• 批准号: 10473753
• 负责人: Molly Elise Ream
• 金额: $ 0.44万
• 依托单位: UNIVERSITY OF MIAMI CORAL GABLES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10473753
• 关键词: Adherence; Affect; Anxiety; Attention; Behavioral; Breast Cancer Patient; Clinical; Clinical Oncology; Cognitive; Cognitive Therapy; Computerized Medical Record; Data; Data Collection; Data Reporting; Diagnosis; Disease; Distress; Educational Intervention; Face; Goals; Health; Health education; Hormone Receptor; Hot flushes; Incidence; Intervention; Life; Linear Models; Literature; Long-Term Effects; Longterm Follow-up; Malignant Neoplasms; Measures; Mediating; Mediation; Mediator of activation protein; Menopause; Mental Depression; Methods; Mission; Moods; Nonmetastatic; Oncology; Operative Surgical Procedures; Outcome; Patient Self-Report; Persons; Pharmaceutical Preparations; Pharmacy facility; Physiological Adaptation; Process; Protocols documentation; Psychosocial Assessment and Care; Randomized Controlled Trials; Records; Recurrence; Relaxation Therapy; Research; Research Personnel; Risk; Role; Running; Savings; Science; Sleeplessness; Social support; Stress; Testing; Therapeutic Intervention; Time; Training; Training and Education; United States; Well in self; Woman; Work; adjuvant endocrine therapy; base; breast cancer diagnosis; cohort; coping; depressive symptoms; effective therapy; experience; follow-up; group intervention; hormone receptor-positive; hormone therapy; improved; intervention effect; malignant breast neoplasm; medication compliance; mortality; prognostic; psychologic; psychological distress; psychosocial; side effect; skills; statistics; stress management; survivorship; therapy adherence; tumor

PROJECT SUMMARY Background. In the United States, 1 in 8 women will be diagnosed with breast cancer in their lifetime, with 1 in 39 women dying from the disease. While breast cancer is highly prevalent and can be deadly, in many cases it is treatable. Adjuvant endocrine therapy (AET) is an effective treatment for the 80% of women with early-stage disease who have hormone receptors expressed in their breast cancer. Although women who complete the recommended 10-year course of AET and consistently take the medication have a significantly reduced chance of recurrence, approximately half of women fail to complete this course of treatment. In addition to coping with debilitating menopausal-related side effects, women with breast cancer face psychosocial barriers that have been associated with poor AET adherence, including anxiety, depression, and poor social support. Importantly, these are modifiable constructs that may contribute to adherence and can be targeted by psychosocial interventions. Research Strategy. The current study aims to 1) test the long-term effects of two brief post-surgical psychosocial interventions, cognitive behavioral therapy (CBT) and Relaxation Training (RT), versus an attention-matched Health Education (HE) control (not focused on medication adherence), on AET adherence at 7 years post-baseline, 2) examine psychosocial mediators of trial effects on AET adherence, and 3) examine whether trial condition and AET adherence are related to 8-14-year recurrence- free survival. I have a unique opportunity to take advantage of an ongoing long-term follow-up from a cohort of women who participated in a randomized controlled trial for 5-week stress management and add measures to assess their adherence to AET and recurrence-free survival. Significance. Our prior work has demonstrated that CBT and RT effectively improved depressive affect, emotional well-being, and stress management skills in the intervention groups in comparison to those receiving the HE control. Given evidence that psychological distress relates to worse AET adherence, it is plausible that women receiving the intervention have had improvements in their AET adherence as a downstream effect of improvements in psychological wellbeing. This study will be the first to test whether a stress management intervention delivered post-surgery may have a long-term impact on AET adherence. If we can facilitate AET adherence early in the disease process through psychological intervention, we may ultimately improve long-term health outcomes. Training Plan. With additional training and experience in statistics, psycho-oncology, and adherence science, this study will lay the groundwork for my goal to become an independent clinical researcher. In line with the NCI’s mission of improving survivorship and helping people live longer, healthier lives, my long-term goals are to elucidate the behavioral processes underlying the effects of stress on cancer outcomes and to target these processes through psychosocial interventions that are feasible in clinical oncology settings.

项目概要 背景。在美国，每 8 名女性中就有 1 人在一生中被诊断出患有乳腺癌，其中 1 人 39名妇女死于这种疾病。虽然乳腺癌非常普遍并且可能致命，但在许多情况下 是可以治疗的。辅助内分泌治疗（AET）对于 80% 的早期女性来说是一种有效的治疗方法 乳腺癌中表达有激素受体的疾病。尽管女性完成了 建议 10 年 AET 疗程并坚持服药可显着降低 复发的可能性，大约一半的女性无法完成这个疗程。此外 为了应对更年期相关的衰弱副作用，乳腺癌女性面临社会心理障碍 与 AET 依从性差有关，包括焦虑、抑郁和社会支持不良。 重要的是，这些是可修改的结构，可能有助于坚持，并且可以通过 心理社会干预。研究策略。当前的研究旨在 1）测试两种方法的长期影响 简短的术后心理社会干预、认知行为治疗 (CBT) 和放松训练 (RT) 与注意力匹配的健康教育 (HE) 控制（不关注药物依从性）相比， 基线后 7 年的 AET 依从性，2) 检查 AET 试验效​​果的社会心理调节因素 依从性，3) 检查试验条件和 AET 依从性是否与 8-14 年复发相关- 自由生存。我有一个独特的机会来利用一群正在进行的长期随访 参加为期 5 周压力管理的随机对照试验并采取额外措施的女性 评估他们对 AET 的依从性和无复发生存期。意义。我们之前的工作已经证明 CBT 和 RT 有效改善了抑郁情绪、情绪健康和压力管理技能 干预组与接受 HE 对照组的比较。有证据表明心理 痛苦与较差的 AET 依从性有关，接受干预的女性可能有 作为心理健康改善的下游效应，他们 AET 依从性的改善。 这项研究将是第一个测试手术后进行的压力管理干预是否可能产生效果的研究。 对 AET 依从性的长期影响。如果我们能够通过以下方式促进疾病早期阶段的 AET 依从性： 心理干预，我们最终可能会改善长期健康结果。培训计划。和 在统计学、心理肿瘤学和依从性科学方面的额外培训和经验，这项研究将为 为我成为一名独立临床研究员的目标奠定了基础。符合 NCI 的使命 提高生存率并帮助人们活得更长久、更健康，我的长期目标是阐明 压力对癌症结果影响的行为过程并针对这些过程 通过在临床肿瘤学环境中可行的心理社会干预措施。