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: 10066728
• 负责人: Molly Elise Ream
• 金额: $ 4.15万
• 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/10066728
• 关键词: Adherence; Affect; Anxiety; Attention; Behavioral; Breast; 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; 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; social; 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.

项目摘要 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人在 39名妇女死于这种疾病。虽然乳腺癌是高度流行的，可以是致命的，在许多情况下， 是可以治疗的辅助内分泌治疗（AET）是一种有效的治疗80%的妇女与早期阶段 在乳腺癌中有激素受体表达的患者。尽管完成了 推荐的10年AET疗程和持续服用药物有显着减少 复发的机会，大约一半的妇女未能完成这一疗程。除了 应对与更年期相关的副作用，乳腺癌妇女面临心理障碍 与AET依从性差有关，包括焦虑、抑郁和社会支持差。 重要的是，这些是可修饰的结构，可能有助于粘附，并且可以被靶向。 心理社会干预。研究战略。目前的研究旨在1）测试两种药物的长期影响， 简短的术后心理社会干预，认知行为疗法（CBT）和放松训练 (RT)与注意力匹配的健康教育（HE）对照（不关注药物依从性）相比， 基线后7年的AET依从性，2）检查试验对AET影响的心理社会介质 依从性，以及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个正在进行的长期随访， 参加了一项为期5周的压力管理随机对照试验的妇女， 评估他们对AET的依从性和无复发生存率。意义我们之前的工作已经证明 CBT和RT有效地改善了抑郁情绪，情绪健康和压力管理技能， 干预组与接受HE对照组相比。有证据表明，心理 痛苦与更差的AET依从性有关，接受干预的妇女有可能 AET依从性的改善是心理健康改善的下游效应。 这项研究将是第一个测试是否压力管理干预提供手术后可能有一个 对AET依从性的长期影响。如果我们能在疾病过程的早期促进AET的坚持， 通过心理干预，我们可能最终改善长期健康结果。培训计划。与 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，这项研究将奠定 我的目标是成为一名独立的临床研究人员。根据NCI的使命， 提高生存率，帮助人们活得更长，更健康，我的长期目标是阐明 行为过程的压力对癌症结果的影响，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。