Grant Number:	1R01CA281885-01A1 Interpret this number
Primary Investigator:	Wells-Di Gregorio, Sharla
Organization:	Ohio State University
Project Title:	Randomized Clinical Trial of a Telemedicine-Mhealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Underserved Rural Communities
Fiscal Year:	2024

Abstract People with advanced cancer experience a greater frequency and severity of physical and psychological symptoms, ranking sleep difficulties, worry-anxiety, depression, and fatigue as four of the most common and distressing symptoms. These symptoms form a symptom cluster, contribute to functional impairment and poorer quality of life, and are undertreated, especially in rural communities. There is strong evidence for biobehavioral interventions to improve these symptoms. However, cognitive-behavioral (CBT) and acceptance and commitment therapies (ACT) are often too time and energy intensive (e.g., 12-20 sessions) and not tailored for people with advanced cancer. Preliminary Results. In response to specific needs of people with advanced cancer, we completed a pilot randomized, controlled trial of a brief, integrated CBT-ACT intervention utilizing the most effective components of these treatments. Finding Our Center Under Stress (FOCUS) is a four-module mHealth intervention that teaches patients how to control symptoms, when possible, while continuing to live meaningfully despite these symptoms. FOCUS participants demonstrated statistically and clinically significant improvements on insomnia severity (d=-0.98), worry (d=-0.86), depression (d=-0.77), fatigue interference (d=-0.59), self-report and physiologic sleep efficiency (effect size d=0.92), sleep latency (d=-0.66), and psychological distress (d =-0.78). The proposed project, guided by the biobehavioral theoretical model, will build on the success of our pilot trial and complete a larger effectiveness trial of FOCUS compared to a telemedicine-mHealth information control on this symptom cluster; evaluate dose-response, particularly among rural patients; and explore biobehavioral mediators of symptom changes. Our primary goal for this study is to improve this symptom cluster, functional status despite symptoms, and quality of life for people with advanced cancer from underserved rural communities. Innovative features include our population (50% rural and Appalachian), symptom cluster focus, telemedicine-mHealth delivery, tailoring for people with advanced cancer, and use of a biobehavioral approach. Aim 1. Evaluate the effectiveness of FOCUS on a symptom cluster (sleep-anxiety-depression-fatigue), Aim 2. Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and gender. Exploratory Aim 3: Examine biobehavioral mediators of treatment effects. Design and Method: This is a prospective, triple blinded (patient, research assistant, statistician), single-site, randomized trial of FOCUS vs information control. We will recruit 120 participants with advanced lung, prostate, breast cancer, myeloma, and melanoma. The trial will take place at The Ohio State University James Comprehensive Cancer Center. All participants will complete assessments at baseline, 6 and 12 weeks, and 6 and 12 months. We hypothesize that FOCUS participants who use the app more frequently will demonstrate improvements on the symptom cluster longitudinally compared to the control group via psychological, inflammatory, and endocrine mediators.





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