Development of A Mindfulness-Based Mobile Health Intervention for Patients Coping with Pain from Advanced Malignancies

为应对晚期恶性肿瘤疼痛的患者开发基于正念的移动健康干预措施

• 批准号: 10599266
• 负责人: ANDREA C Enzinger
• 金额: $ 20.45万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10599266
• 关键词: Advanced Malignant Neoplasm; Affect; Affective; Algorithms; Analgesics; Anxiety; Attention; Behavioral; Benchmarking; Cancer Center; Cancer Patient; Caring; Cessation of life; Chronic Cancer Pain; Clinic; Clinical; Cognition; Cognitive; Complement; Comprehensive Cancer Center; Coping Skills; Data Collection; Development; Diagnosis; Dimensions; Disease; Distal; Distress; Ecological momentary assessment; Emergency department visit; Emotional; Emotions; Esthesia; Exercise; Feedback; Fright; Future; Goals; Health Technology; Home; Home environment; Intervention; Interview; Malignant Neoplasms; Measures; Mediator; Meditation; Mental Depression; Mental Health; Meta-Analysis; Mind-Body Intervention; Mindfulness Training; Modeling; Multimedia; Nature; Nerve; Oncology; Opioid; Organ; Outcome; Outpatients; Pain; Pain Measurement; Pain intensity; Pain interference; Pain management; Palliative Care; Patients; Persistent pain; Personal Satisfaction; Persons; Pharmaceutical Preparations; Pharmacotherapy; Physical Function; Pilot Projects; Population; Principal Investigator; Process; Psychology; Quality of life; Randomized; Reaction; Schedule; Self Management; Sensory; Series; Severities; Solid; Sum; Surveys; Survivors; Symptoms; Target Populations; Testing; Thinking; Time; Training; Vulnerable Populations; Writing; advanced disease; animation; biopsychosocial; bone; cancer complication; cancer pain; cancer palliative treatment; chronic pain; chronic pain patient; cognitive process; coping; design; efficacious intervention; efficacy study; emotional reaction; end of life; experience; flexibility; follow-up; group counseling; health application; health care service utilization; holistic approach; improved; intervention effect; mHealth; mindfulness; mindfulness intervention; mindfulness meditation; mortality; multi-component intervention; non-cancer chronic pain; novel; opioid use; pain outcome; pain sensation; patient population; primary outcome; programs; psychoeducation; psychoeducational; psychologic; randomized trial; recruit; response; satisfaction; side effect; skills training; smartphone application; social; trend; tumor; tumor progression; usability

PROJECT SUMMARY Pain affects approximately two thirds of patients with advanced, incurable cancer, with rates approaching 90% near the end-of-life. Advanced cancer pain can be notoriously severe, degrading patients' emotional, social, and functional wellbeing. Advanced cancer pain is a multidimensional process that requires a holistic approach to care. Unfortunately, in real world settings pharmacotherapy is often the only treatment available to patients. Mindfulness has been defined as a directed, flexible cognitive process that allows a person to observe thoughts and emotions in the moment, as opposed to reacting to them. Applied to chronic pain, mindfulness seeks to decouple the sensory experience of pain from cognitive interpretations and emotional reactions – a ideal strategy for advanced cancer pain given the close connection between pain sensations and cognitive- affective responses (e.g. fears of cancer progression and death). Mindfulness has been proven effective for chronic pain from a variety of non-cancer diagnoses, but studies of mindfulness for advanced cancer pain are lacking. Traditional mindfulness programs, which involve 8 weeks of lengthy group-based trainings with daily practice, are impractical and inaccessible to most advanced cancer patients. Moreover, existing programs are not adapted to this populations' physical limitations, often intense emotional and existential distress, nor do they support other vital aspects of self-management required to successfully cope with cancer pain at home. The object of this proposal is to develop, refine and pilot CHAMP (Cancer Health Application for Mindfulness- based Pain treatment), a novel smartphone application to deliver mobile mindfulness training tailored to the needs of patients with advanced cancer pain. To complement mindfulness practice, CHAMP will integrate multimedia cancer pain psychoeducation and medication support, maximizing patients' ability to cope and self- manage. This project is made feasible by the team's ability to leverage mindfulness content, multi-media cancer pain psychoeducation, and design features from two existing mHealth projects (R21 NR017745, and R00 MD010468). In Aim 1a, the study team will develop and program CHAMP, involving the target patient population for multiple levels of review and revision. In Aim 1b, a small pre-pilot will be conducted (N=5) in order to refine the app prior a pilot study. In Aim 2, 20 patients with persistent pain from a variety of advanced solid malignancies at a major academic cancer center will be assigned to use CHAMP for 8 weeks. Findings will illuminate the feasibility of data collection, allow exploration of meaningful trends, and enable the design of a future randomized trial to test the ability of CHAMP to improve pain and QOL for advanced cancer patients. The sum result of this project will be a tailored, mindfulness intervention which - if proven effective - has great potential to scale and make mind-body treatment available to a population that suffers disproportionately from chronic pain and currently has extremely limited access to effective, non-pharmacologic management.

项目概要 大约三分之二的晚期、无法治愈的癌症患者都会受到疼痛的影响，比例接近 90% 晚期癌症疼痛可能非常严重，会降低患者的情绪、社交能力和社交能力。 晚期癌症疼痛是一个多维过程，需要采取整体方法。 不幸的是，在现实世界中，药物治疗通常是患者可用的唯一治疗方法。 正念被定义为一种定向的、灵活的认知过程，它允许一个人观察 当下的想法和情绪，而不是对它们做出反应，正念。 试图将疼痛的感官体验与认知解释和情绪反应脱钩—— 鉴于疼痛感觉和认知之间的密切联系，这是治疗晚期癌症疼痛的理想策略 情感反应（例如对癌症进展和死亡的恐惧）已被证明是有效的。 各种非癌症诊断引起的慢性疼痛，但针对晚期癌症疼痛的正念研究 传统的正念计划需要每天进行为期 8 周的长时间小组训练。 对于大多数晚期癌症患者来说，现有的计划是不切实际且无法实现的。 不适应这些人群的身体限制，往往是强烈的情感和生存困扰，也不适应 他们支持在家中成功应对癌症疼痛所需的自我管理的其他重要方面。 该提案的目的是开发、完善和试点 CHAMP（癌症健康正念应用程序） 基于疼痛治疗），一种新颖的智能手机应用程序，可提供针对患者量身定制的移动正念训练 为了补充正念练习，CHAMP 将整合晚期癌症疼痛患者的需求。 多媒体癌痛心理教育和药物支持，最大限度地提高患者的应对和自我缓解能力 团队利用正念内容和多媒体的能力使该项目变得可行。 癌症疼痛心理教育，以及两个现有移动医疗项目（R21 NR017745 和 在目标 1a 中，研究团队将开发和编程 CHAMP，其中涉及目标患者。 在目标 1b 中，将进行一次小型预试点（N=5）。 为了在目标 2 中对 20 名患有各种晚期疼痛的患者进行试点研究之前完善该应用程序。 大型学术癌症中心的实体恶性肿瘤将被分配使用 CHAMP 8 周的结果。 将阐明数据收集的可行性，允许探索有意义的趋势，并实现设计 未来的一项随机试验将测试 CHAMP 改善晚期癌症患者疼痛和生活质量的能力。 该项目的总结果将是量身定制的正念干预措施，如果被证明有效的话，将具有巨大的作用 有潜力扩大规模并为遭受不成比例的痛苦的人群提供身心治疗 慢性疼痛，目前获得有效的非药物治疗的机会极其有限。