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.

项目摘要 疼痛影响大约三分之二的晚期、不可治愈的癌症患者，患病率接近90%。 接近生命的尽头。晚期癌症疼痛可能非常严重，会降低患者的情感，社交， 和功能健康。晚期癌症疼痛是一个多方面的过程，需要采取整体方法 在意不幸的是，在真实的世界环境中，药物治疗往往是患者唯一可用的治疗方法。 正念被定义为一种有方向的，灵活的认知过程，允许一个人观察 而不是对它们做出反应。应用于慢性疼痛，正念 试图将疼痛的感官体验与认知解释和情感反应分离开来- 鉴于疼痛感觉和认知之间的密切联系， 情感反应（例如对癌症进展和死亡的恐惧）。正念已被证明是有效的， 慢性疼痛的各种非癌症诊断，但正念的研究，先进的癌症疼痛， 缺乏传统的正念课程，包括8周的长期小组培训，每天 实践中，大多数晚期癌症患者都是不切实际和无法获得的。此外，现有方案 不适应这些人群的身体限制，通常是强烈的情感和存在的痛苦，也不 它们支持在家中成功科普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（癌症健康应用程序的正念- 基于疼痛治疗），一种新颖的智能手机应用程序，提供专为患者量身定制的移动的正念训练。 晚期癌痛患者的需求。为了补充正念练习，CHAMP将整合 多媒体癌症疼痛心理教育和药物支持，最大限度地提高患者的科普能力和自我， 管理。这个项目是可行的团队的能力，利用正念内容，多媒体 癌症疼痛心理教育，以及两个现有移动健康项目的设计特征（R21 NR 017745， R00 MD010468）。在目标1a中，研究团队将开发和编程CHAMP，涉及目标患者 多层次审查和翻修的人群。在目标1b中，将在以下地点进行小型预试验（N=5）： 以便在试点研究之前完善应用程序。在目标2中，20名患有各种晚期疼痛的患者， 在主要学术癌症中心的实体恶性肿瘤将被分配使用CHAMP 8周。结果 将阐明数据收集的可行性，允许探索有意义的趋势，并使设计 一项未来的随机试验，以测试CHAMP改善晚期癌症患者疼痛和生活质量的能力。 这个项目的总结果将是一个量身定制的，正念干预-如果证明有效-有很大的 有可能扩大规模，使身心治疗提供给人口，不成比例地遭受 慢性疼痛，目前获得有效的非药物治疗的途径极其有限。