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: 9884954
• 负责人: John David Creswell
• 金额: $ 57.81万
• 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/9884954
• 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.

项目总结/摘要 本研究的主要目的是评估一个简短而有效的价值肯定写作是否 干预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（AIs）。大多数绝经后妇女被诊断为乳腺癌， 处方AI;虽然有效，但这些药物会导致有毒的身体症状副作用， 坚持性差。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，因此提高了使用AI的乳腺癌患者的生存率。在试点工作中 从我们的小组和其他人，思考或写的重要个人价值观的价值肯定干预措施 与更少的身体症状，减少压力和改善药物依从性有关。而 这些初步研究的样本量很小，或者本质上是横断面的，没有评估 干预效应的潜在神经生物学机制。拟定的研究将是一项随机化研究， 对照试验（RCT）比较了6个月的便携式价值肯定书写干预（N=125）与 对照书写干预（N=125）在乳腺癌患者服用芳香化酶抑制剂。参与者将 在基线、干预后完成身体症状、依从性和压力的自我报告测量，以及 6-月随访。药物依从性也将通过电子药瓶报告和补充进行评估 研究期间的潜伏期。作为探索性机制目标，来自父母的AI患者的子样本 RCT（N=120，每个干预组60例）将完成中期干预值确认或对照书写 在接受功能性MRI检查的同时完成任务。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：如果价值肯定写作减少了身体症状和压力（目标1）， 药物依从性（目标2），如果在价值肯定过程中神经奖励激活是神经生物学的， 这些益处的机制（探索性目标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，以减少症状，压力， 服用人工免疫药物的乳腺癌患者的药物不依从性。