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

管理补充：将疼痛 CBT 纳入 mHealth 镇痛支持干预中，以治疗晚期癌症引起的慢性疼痛

基本信息

批准号：
10767398
负责人：
Desiree R Azizoddin
金额：
$ 5.2万
依托单位：
UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
依托单位国家：
美国
项目类别：
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

项目摘要

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。认知行为疼痛治疗（pain-CBT）是治疗癌症引起的慢性疼痛的有效方法。不幸的是，疼痛 CBT 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，并且理想情况下应与其药物治疗（例如阿片类药物）计划相结合。移动医疗（mHealth）技术是一种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晚期无法治愈的癌症带来的疼痛。利用共同导师的应用程序（R21 资助的）、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的使用监测并提供量身定制的疼痛教育和建议。遵循 NIH 行为阶段模型干预开发（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 将发展并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 访谈、线框和用户可接受性测试 (AIM 1A)。 STAMP+CBT 将被编程并且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 + 数字癌症疼痛教育6周。研究的可行性将通过检查招募/保留率和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采访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 STAMP+CBT 未来 (R01) 疗效试验的设计提供信息。阿齐佐丁博士的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）。这个K08 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) 进行瞬时纵向分析疼痛/心理移动健康数据。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。