NCT07102212

Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Center Under Stress (FOCUS)

Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The investigators will deliver an evidence-based intervention for a common cancer symptom cluster, with clinically significant pilot findings, to rural, underserved people with advanced cancer. The investigators will improve access via a telemedicine- mHealth approach, developed and refined based on the needs and evaluative feedback of people with advanced cancer. The investigators aim to reduce symptom severity and interference via an integrated CBT-ACT intervention. In addition, the investigators will examine the behavioral, hormonal, and inflammatory mechanisms of symptom change including several novel biomarkers identified in the pilot trial (e.g., IL-12, IL-1alpha, TNFbeta). An effective, accessible, brief alternative to medication-based symptom cluster management is essential given the limited availability of palliative and psychosocial care for this population and impact of these symptoms on patient functional status, quality of life, treatment adherence, and survival. The study aligns with NCI's goal to enhance access to clinical trials via telemedicine and mobile applications to better meet the survivorship needs of underserved populations and the goal of RFA CA-22-027 to test interventions to improve delivery of comprehensive survivorship care for individuals with advanced cancer. SPECIFIC AIMS: Aim 1: Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer Aim 2: Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and other demographics Aim 3 (Exploratory): Examine biobehavioral mediators of treatment effects

Conditions

• Lung Cancer
• Breast Cancer
• Prostate Cancer
• Multiple Myeloma
• Melanoma

Interventions

Type	Name	Description
BEHAVIORAL	mHealth Intervention	Participants are randomized to the FOCUS app or Information Control section of the app and will have six weeks to complete the app. Randomization, via the app, is stratified by geographic location (rural vs other), cancer type, and demographics so experimental arms are equivalent. Participants will complete 5 assessments online over a 12-mo period. The participants will have weekly telehealth professional support during the six-week intervention. Participants wear GeneActiv watches for sleep/activity recording for 7 days and provide blood and saliva samples at baseline, 6 and 12 weeks, and 6 and 12 months.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-08-31
• Completion: 2029-09-30
• First posted: 2025-08-03
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States