A value affirmation intervention for physical symptoms and medication adherence in breast cancer patients taking aromatase inhibitors

对服用芳香酶抑制剂的乳腺癌患者的身体症状和药物依从性进行价值肯定干预

• 批准号: 10311024
• 负责人: John David Creswell
• 金额: $ 53.13万
• 依托单位: CARNEGIE-MELLON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10311024
• 关键词: Acute; Adherence; Aromatase Inhibitors; Arthralgia; Behavioral; Biological; Brain; Breast Cancer Patient; Breast Cancer survivor; Buffers; Chronic; Control Groups; Diagnosis; Estrogen receptor positive; Evidence based intervention; Exercise; Functional Magnetic Resonance Imaging; Hot flushes; Intervention; Laboratories; Lead; Link; Malignant Neoplasms; Measures; Mediating; Moods; National Cancer Institute; Nature; Outcome; Pain; Parents; Participant; Pathway interactions; Patient Self-Report; Patients; Pharmaceutical Preparations; Physiological; Pilot Projects; Postmenopause; Procedures; Quality of life; Randomized; Randomized Controlled Trials; Recurrence; Regimen; Reporting; Research; Research Personnel; Rewards; Risk; Sampling; Stress; Survival Rate; Testing; Thinking; Ventral Striatum; Woman; Work; Writing; base; biological adaptation to stress; breast cancer survival; cancer therapy; cost; cost effective; follow-up; functional MRI scan; health care availability; high risk; hormone therapy; improved; intervention effect; malignant breast neoplasm; medication compliance; medication nonadherence; mortality; neurobiological mechanism; neuroimaging; perceived stress; physical conditioning; physical symptom; pill; portability; post intervention; psychologic; reduce symptoms; relating to nervous system; response; side effect; social; stress reactivity; stress symptom; stressor; success; survival outcome; symptom management; treatment arm; trial comparing; web portal

PROJECT SUMMARY/ABSTRACT The broad aim of this research is to evaluate whether a brief and cost-effective value affirmation writing intervention reduces physical symptoms, stress and medication non-adherence among breast cancer patients taking aromatase inhibitors (AIs). The majority of postmenopausal women diagnosed with breast cancer will be prescribed an AI; and while effective, these medications lead to toxic physical symptom side effect profiles and poor adherence. Interventions that target these side effects and the stress they cause may lead to improved medication adherence and therefore improved survival rates for breast cancer patients taking AIs. In pilot work from our group and others, thinking or writing about important personal values in value affirmation interventions have been linked to fewer physical symptoms, decreased stress, and improved medication adherence. While promising, these initial studies had small samples or were cross sectional in nature, and did not evaluate potential neurobiological mechanisms for intervention effects. The proposed study will be a randomized controlled trial (RCT) comparing a 6-month, portable value affirmation writing intervention (N=125) to a control writing intervention (N=125) in breast cancer patients taking aromatase inhibitors. Participants will complete self-reported measures of physical symptoms, adherence and stress at baseline, post-intervention, and 6-month follow-up. Medication adherence will also be assessed via electronic pill bottle reporting and refill latency during the study period. As an exploratory mechanistic aim, a subsample of AI patients from the parent RCT (N=120, 60 per intervention arm) will complete their mid-intervention value affirmation or control writing task while undergoing functional MRI. Thus, the proposed study will test two specific aims and an exploratory aim to determine: if value affirmation writing reduces physical symptoms and stress (Aim 1), improves medication adherence (Aim 2), and if neural reward activation during value affirmation is a neurobiological mechanism for these benefits (Exploratory Aim 1). The proposed RCT has the potential to identify a powerful, cost-effective, and easy-to-implement value affirmation intervention for reducing symptoms, stress, and medication non-adherence in breast cancer patients taking AIs.

项目概要/摘要 本研究的主要目标是评估简短且具有成本效益的价值肯定写作是否有效 干预可减少乳腺癌患者的身体症状、压力和药物不依从性 服用芳香酶抑制剂（AI）。大多数绝经后妇女被诊断患有乳腺癌 规定人工智能；虽然有效，但这些药物会导致有毒的身体症状和副作用 依从性差。针对这些副作用及其引起的压力的干预措施可能会导致改善 药物依从性，从而提高服用 AI 的乳腺癌患者的生存率。试点工作中 来自我们的团队和其他人，在价值肯定干预中思考或撰写重要的个人价值观 与减少身体症状、减轻压力和提高药物依从性有关。尽管 有前途，这些初步研究样本较小或本质上是横断面的，并且没有评估 干预效果的潜在神经生物学机制。拟议的研究将是一项随机 对照试验 (RCT) 将为期 6 个月的便携式价值肯定写作干预 (N=125) 与 对服用芳香酶抑制剂的乳腺癌患者进行控制写作干预（N = 125）。参与者将 完整的自我报告测量基线、干预后的身体症状、依从性和压力 6个月的随访。药物依从性还将通过电子药瓶报告和补充进行评估 研究期间的潜伏期。作为一个探索性的机制目标，来自父母的 AI 患者的子样本 RCT（N=120，每个干预组 60 个）将完成中期干预价值确认或对照写作 在进行功能性 MRI 时执行任务。因此，拟议的研究将测试两个具体目标和一个探索性的 目的是确定：价值肯定写作是否可以减少身体症状和压力（目标 1）、改善 药物依从性（目标 2），以及价值肯定期间的神经奖励激活是否是一种神经生物学 这些好处的机制（探索性目标 1）。拟议的随机对照试验有可能确定一个强大的、 具有成本效益且易于实施的价值肯定干预措施，可减轻症状、压力和 服用 AI 的乳腺癌患者不遵守药物治疗。