Integrating pain-CBT into an mHealth analgesic support intervention for patients with chronic pain from advanced cancers

将疼痛 CBT 纳入 mHealth 镇痛支持干预中，治疗晚期癌症慢性疼痛患者

• 批准号: 10655306
• 负责人: Desiree R Azizoddin
• 金额: $ 19.15万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10655306
• 关键词: Active Learning; Advanced Malignant Neoplasm; Advisory Committees; Affect; Algorithms; Analgesics; Attention; Award; Behavior; Behavior Therapy; Behavioral; Behavioral Model; Behavioral trial; Cancer Intervention; Cancer Patient; Cancer Survivor; Cellular Phone; Chronic Cancer Pain; Clinical Trials; Cognitive Therapy; Complement; Complication; Constipation; Coping Skills; Data; Data Analytics; Dedications; Development; Distress; Doctor of Philosophy; Ecological momentary assessment; Education; Emergency Situation; Exercise; Fatigue; Feasibility Studies; Funding; Future; Goals; Health Technology; Intervention; Intervention Studies; Interview; Knowledge; Learning; Life; Malignant - descriptor; Malignant Neoplasms; Measures; Medical; Medication Management; Mentors; Mentorship; Methods; Mission; Mobile Health Application; Monitor; Moods; Multimedia; Online Systems; Opioid; Pain; Pain intensity; Pain interference; Pain management; Palliative Care; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Population; Preparation; Psychological Factors; Psychology; Quality of life; Randomized; Relaxation; Research; Research Activity; Research Personnel; Scientific Advances and Accomplishments; Secondary pain; Sedation procedure; Self Efficacy; Self Management; Self-Examination; Series; Service delivery model; Severities; Solid; Stress; Structure; Surveys; Symptoms; Target Populations; Technology; Testing; Time; Training; Training Programs; United States National Institutes of Health; Video Recording; Visit; Work; acceptability and feasibility; behavioral clinical trial; biopsychosocial; cancer pain; cancer therapy; chronic pain; chronic pain management; chronic pain patient; curative treatments; daily pain; design; digital healthcare; disability; effective therapy; efficacy study; efficacy trial; experience; feasibility testing; improved; intervention refinement; longitudinal analysis; mHealth; mobile application; negative mood; non-cancer chronic pain; novel; opioid use; pain catastrophizing; pain outcome; pain relief; pain self-management; palliate; patient subsets; pharmacologic; pilot trial; programs; psychoeducation; psychoeducational; psychologic; randomized, clinical trials; recruit; research faculty; retention rate; secondary outcome; side effect; skills training; smartphone application; telehealth; therapy design; therapy development; treatment as usual; treatment duration; trial design

PROJECT SUMMARY/ABSTRACT Pain affects approximately two thirds of patients with advanced incurable cancers. Cognitive Behavioral Therapy for pain (pain-CBT) is an effective treatment for chronic pain from cancer. Unfortunately, pain-CBT in its traditional format (60-minute, in-person sessions) is often unrealistic for patients with advanced cancer. Behavioral treatments require substantial adaptation to meet advanced cancer patients’ real-life needs, and should ideally integrate with their pharmacotherapy (e.g. opioid) plans. Mobile health (mHealth) technology is a promising strategy to deliver and ultimately disseminate brief pain-CBT interventions to cancer patients. The goal of Dr. Azizoddin’s K08 proposal is to develop a novel mHealth application that integrates brief pain- CBT into an existing mHealth application designed to optimize opioid management for patients with chronic pain from advanced incurable cancers. Leveraging co-mentor’s app (R21-funded), Smartphone Technology to Alleviate Malignant Pain (STAMP) is a patient-facing smartphone app that facilitates daily symptom and opioid monitoring and delivers tailored pain education and advice. Following the NIH Stage Model for Behavioral Intervention Development (Stage:1A&1B), Dr. Azizoddin will create STAMP+CBT, a novel intervention that harmonizes psychological and medical support for advanced cancer pain. In AIM 1: the PI will develop and refine STAMP+CBT by adapting pain-CBT for brief mHealth delivery through a series of iterative qualitative interviews, and wireframe and user acceptability testing (AIM 1A). STAMP+CBT will be programmed and tested in a small pre-pilot with the target population to inform app refinements (AIM 1B). In AIM 2: 60 patients with chronic pain related to advanced cancer will be randomized to the app or usual care + digital cancer pain education for 6 weeks. Feasibility of the study will be determined by examining recruitment/retention rates and completion rates of app-delivered pain-CBT content. A subset of patients will complete qualitative debriefing interviews to inform final app refinements. Measures will explore anticipated primary (pain interference) and secondary pain outcomes to inform the design of a future (R01) efficacy trial of STAMP+CBT. Dr. Azizoddin’s research activities will be mentored by an interdisciplinary team of expert investigators in pain psychology (Robert Edwards, PhD), palliative care clinical trials (Andrea Enzinger, MD & James Tulsky, MD), cancer pain (Christine Miaskowski, PhD), and mobile health (Michael Businelle, PhD & Daniel Gundersen, PhD). This K08 proposal will allow Dr. Azizoddin to acquire training in: 1) adapting psychological pain interventions for cancer populations, 2) learning rigorous methods to develop/refine behavioral mHealth interventions, 3) conducting randomized clinical trials of behavioral interventions, and 4) conducting longitudinal analysis of momentary pain/psychological mHealth data. This training program and structured mentorship under the guidance of esteemed research faculty will provide Dr. Azizoddin with the support necessary to become a successful, independent investigator, specializing in effective and scalable behavioral treatments to improve cancer pain.

项目摘要/摘要 疼痛影响着大约三分之二的晚期不治之癌患者。认知行为 疼痛疗法(Pain-CBT)是治疗癌症慢性疼痛的一种有效方法。不幸的是，Pain-CBT in 它的传统模式(60分钟的面对面治疗)对于晚期癌症患者来说往往是不现实的。 行为治疗需要实质性的适应，以满足晚期癌症患者的现实生活需求，以及 理想情况下应与他们的药物治疗(如阿片类药物)计划相结合。移动医疗(MHealth)技术是 有希望的战略是向癌症患者提供并最终传播简短的疼痛-CBT干预措施。 阿齐佐丁博士K08提案的目标是开发一种新型的mHealth应用程序，它集成了短暂的疼痛- 将CBT整合到现有的mHealth应用程序中，旨在优化慢性阻塞性肺疾病患者的阿片类药物管理 晚期不治之癌引起的疼痛。利用联合导师的应用程序(由R21资助)，智能手机技术 缓解恶性疼痛(STAMP)是一款面向患者的智能手机应用程序，可缓解日常症状和阿片类药物 监测和提供量身定制的疼痛教育和建议。遵循NIH的行为阶段模型 干预发展(阶段：1A和1B)，Azizoddin博士将创建STAMP+CBT，这是一种新的干预方法 协调晚期癌症疼痛的心理和医疗支持。在目标1中：PI将发展和 通过一系列迭代定性调整Pain-CBT来优化STAMP+CBT，以实现简短的mHealth交付 访谈、线框图和用户可接受性测试(AIM 1A)。将对STAMP+CBT进行编程并 在小型预试运行中与目标人群一起进行测试，以告知应用程序改进(AIM 1B)。在AIM 2：60名患者 与晚期癌症相关的慢性疼痛将被随机分配到APP或常规护理+数字癌症疼痛 为期6周的教育。这项研究的可行性将通过审查招聘/保留率和 APP交付的Pain-CBT内容的完成率。一部分患者将完成定性汇报 面谈以通知最终的应用程序改进。措施将探索预期的原发(疼痛干预)和 继发性疼痛结果为STAMP+CBT未来(R01)疗效试验的设计提供信息。阿齐佐丁医生的 研究活动将由疼痛心理学的跨学科专家调查小组指导 (Robert Edwards博士)，姑息治疗临床试验(Andrea Enzinger医学博士和James Tulsky医学博士)，癌症疼痛 (Christine Miaskowski博士)和移动健康(Michael Businelle博士和Daniel Gundersen博士)。这个K08 该提案将允许阿齐佐丁博士在以下方面获得培训：1)调整癌症的心理疼痛干预 人口，2)学习制定/改进行为mHealth干预的严格方法，3)进行 行为干预的随机临床试验，以及4)对瞬时 疼痛/心理健康数据。这一培训计划和结构化的指导在 尊敬的研究人员将为阿齐佐丁博士提供必要的支持，使他成为一名成功的， 独立研究人员，专门从事有效和可扩展的行为治疗，以改善癌症疼痛。