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

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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.