In response to the symptom needs experienced in advanced cancer, the investigators developed a brief, integrated CBT-ACT symptom management intervention, Finding Our Center Under Stress (FOCUS). Using FOCUS, participants learn skills to self-manage sleep, worry-anxiety, depression, and fatigue and improve their ability to focus on what matters most to them despite these symptoms. Results of the pilot randomized controlled trial with people with advanced cancer demonstrate improved sleep on both self-report and physiologic (i.e., actigraphy) measures, and improvements on worry, depression, and fatigue interference with strong effect sizes ranging from d= 0.59 to 0.98 and sleep effects 12 months post-treatment. The investigators refined the fatigue module with exercise modifications and beta-tested the FOCUS intervention as an mHealth web-based app for acceptability with 10 diverse patients with advanced cancer -100% would recommend for other advanced cancer patients. The overall objective of this proposed randomized effectiveness trial is to evaluate the impact of this telemedicine-mHealth symptom cluster intervention with patients from rural and Appalachian communities (where the PI was raised). Innovative features include a focus on a symptom cluster including anxiety, integrated CBT-ACT intervention, telemedicine-mHealth delivery method, and biobehavioral approach evaluating behavioral and inflammatory mediators.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Insomnia Severity Index
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
Center for Epidemiological Studies Depression Scale
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
Fatigue Severity Index
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
Generalized Anxiety Disorder
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
App Dose and Use
Timeframe: Up to 12 months
Symptom Interference/Quality of Life
Timeframe: Baseline, 6 and 12 weeks, 6 and 12 months
The Ohio State University Comprehensive Cancer Center