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

项目总结/摘要 疼痛影响大约三分之二的晚期不可治愈的癌症患者。认知行为 疼痛治疗（疼痛-CBT）是癌症慢性疼痛的有效治疗方法。不幸的是，疼痛认知行为疗法 它的传统形式（60分钟，面对面的会议）对晚期癌症患者来说往往是不现实的。 行为治疗需要大量的适应，以满足晚期癌症患者的现实生活需要， 理想情况下，应与药物治疗（如阿片类药物）计划相结合。移动的健康（mHealth）技术是一种 这是一项有前途的战略，旨在向癌症患者提供并最终传播简短的疼痛CBT干预措施。 Azizoddin博士的K 08提案的目标是开发一种新的移动健康应用程序，将短暂的疼痛- CBT整合到现有的移动健康应用程序中，旨在优化慢性病患者的阿片类药物管理。 无法治愈的晚期癌症带来的疼痛利用共同导师的应用程序（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，可促进日常症状和阿片类药物 监测并提供量身定制的疼痛教育和建议。根据NIH行为阶段模型 干预发展（阶段：1A和1B），Azizoddin博士将创建STAMP+CBT，一种新的干预， 协调晚期癌症疼痛的心理和医疗支持。在目标1中：PI将开发和 通过一系列迭代定性分析， 访谈、线框和用户可接受性测试（AIM 1A）。将对STAMP+CBT进行编程， 在目标人群中进行了小规模的预试点测试，以告知应用程序的改进（AIM 1B）。在AIM 2中：60例患者 患有与晚期癌症相关的慢性疼痛的患者将被随机分配至app或常规护理+数字癌症疼痛 为期6周的教育。研究的可行性将通过审查征聘/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报告 采访，以告知最终的应用程序改进。措施将探索预期的主要（疼痛干扰）和 继发性疼痛结局，为STAMP+CBT未来（R 01）疗效试验的设计提供信息。阿兹兹丁医生 研究活动将由一个跨学科的疼痛心理学专家研究小组指导 （Robert Edwards，PhD），姑息治疗临床试验（Andrea Enzinger，MD & James Tulsky，MD），癌症疼痛 （克莉丝汀米亚斯科夫斯基博士）和移动的健康（迈克尔·厄格尔博士和丹尼尔·冈德森博士）。K08 该提案将允许Azizoddin博士获得以下培训：1）适应癌症的心理疼痛干预 人口，2）学习严格的方法来开发/完善行为mHealth干预措施，3）进行 行为干预的随机临床试验，以及4）进行瞬时的纵向分析， 疼痛/心理mHealth数据。该培训计划和指导下的结构化指导， 尊敬的研究人员将为Azizoddin博士提供必要的支持， 独立研究员，专门从事有效和可扩展的行为治疗，以改善癌症疼痛。

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.