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: 10535476
• 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 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10535476
• 关键词: Acute; Adherence; Aromatase Inhibitors; Arthralgia; Behavioral; Biological; Brain; Breast Cancer Patient; Breast Cancer survivor; Buffers; Chronic; Control Groups; Diagnosis; Electronics; 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 Reduction; Sampling; Stress; Survival Rate; Testing; Thinking; Ventral Striatum; Woman; Work; Writing; biological adaptation to stress; breast cancer survival; cancer therapy; comparison control; 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; neural; neurobiological mechanism; neuroimaging; perceived stress; physical conditioning; physical symptom; pill; portability; post intervention; psychologic; reduce symptoms; response; side effect; social; stress reactivity; stress reduction; 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.

项目摘要/摘要 这项研究的广泛目的是评估是否简短且具有成本效益的价值肯定写作 干预降低乳腺癌患者的身体症状，压力和药物不遵守 服用芳香酶抑制剂（AIS）。大多数被诊断为乳腺癌的绝经后妇女将是 规定了AI；虽然有效，但这些药物会导致有毒的身体症状副作用特征和 依从性不佳。针对这些副作用及其引起的压力的干预措施可能会改善 药物依从性，因此提高了接受AIS的乳腺癌患者的存活率。在飞行员工作中 从我们的小组和其他人那里，思考或写作价值肯定干预中的重要个人价值观 与较少的身体症状，减轻压力和改善的药物依从性有关。尽管 有希望的是，这些初步研究的样本很小或本质上是横截面，并且没有评估 干预效果的潜在神经生物学机制。拟议的研究将是一个随机的 对照试验（RCT）比较了6个月的便携式价值肯定写作干预措施（n = 125） 在服用芳香酶抑制剂的乳腺癌患者中，对照写作干预（n = 125）。参与者会 完全自我报告的身体症状，依从性和压力在基线，干预后以及 6个月的随访。还将通过电子药瓶报告和补充来评估药物依从性 研究期间的延迟。作为探索性机械的目的，父母的AI患者子样本 RCT（n = 120，60，每个干预组）将完成其中等干预价值的肯定或控制写作 在进行功能性MRI时任务。因此，拟议的研究将测试两个具体目标和一个探索性 旨在确定：是否有价值的肯定写作减轻了身体症状和压力（AIM 1），改善 药物依从性（AIM 2），如果在价值肯定期间的神经奖励激活是神经生物学 这些好处的机制（探索目的1）。拟议的RCT有可能确定一个强大的， 具有成本效益，易于实施的价值肯定干预措施，以减轻症状，压力和 服用AIS的乳腺癌患者的药物不牢固。