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.

项目概要/摘要 大约三分之二的晚期不可治愈癌症患者受到疼痛的影响。 疼痛治疗（疼痛 CBT）是治疗癌症引起的慢性疼痛的有效方法。 它的传统形式（60 分钟、面对面的会议）对于晚期癌症患者来说通常是不现实的。 行为治疗需要大量适应才能满足晚期癌症患者的现实生活需求，并且 理想情况下，移动医疗 (mHealth) 技术应与其药物治疗（例如阿片类药物）计划相结合。 向癌症患者提供并最终传播简短的疼痛 CBT 干预措施的有希望的策略。 Azizoddin 博士的 K08 提案的目标是开发一种新颖的 mHealth 应用程序，该应用程序集成了简短的疼痛- CBT 融入现有的移动医疗应用程序，旨在优化慢性病患者的阿片类药物管理 利用共同导师的应用程序（R21 资助）、智能手机技术来缓解晚期不可治愈癌症带来的疼痛。 缓解恶性疼痛 (STAMP) 是一款面向患者的智能手机应用程序，可促进日常症状和阿片类药物的使用 遵循 NIH 行为阶段模型，监测并提供量身定制的疼痛教育和建议。 干预开发（阶段：1A&1B），Azizoddin 博士将创建 STAMP+CBT，这是一种新颖的干预措施， 协调晚期癌症疼痛的心理和医疗支持 在 AIM 1 中：PI 将发展和发展。 通过一系列迭代定性调整，将疼痛 CBT 用于短暂的移动医疗交付，从而完善 STAMP+CBT 将进行访谈、线框图和用户可接受性测试（AIM 1A）。 在小型预试点中与目标人群进行测试，以告知应用程序改进（AIM 1B）：在 AIM 2 中：60 名患者。 与晚期癌症相关的慢性疼痛将被随机分配到应用程序或常规护理 + 数字癌症疼痛 为期 6 周的教育将通过检查招募/保留率来确定。 应用程序提供的疼痛 CBT 内容的完成率 一部分患者将完成定性汇报。 访谈以告知最终的应用程序改进，措施将探讨预期的主要（疼痛干扰）和 次要疼痛结果可为 Azizoddin 博士未来 (R01) 疗效试验的设计提供信息。 研究活动将由疼痛心理学专家研究人员组成的跨学科团队指导 （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）。 该提案将使 Azizoddin 博士获得以下方面的培训：1）针对癌症采用心理疼痛干预措施 人群，2) 学习严格的方法来开发/完善行为移动健康干预措施，3) 进行 行为干预的随机临床试验，以及 4) 进行瞬时纵向分析 该培训计划和结构化指导是在以下人员的指导下进行的： 受人尊敬的研究人员将为阿齐佐丁博士提供必要的支持，使其成为一名成功的、 独立研究者，专门从事有效且可扩展的行为治疗以改善癌症疼痛。