This clinical trial studies whether a telemedicine-mobile health (mHealth) intervention, Finding Our Center Under Stress (FOCUS), improves symptom management in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients with advanced cancer often experience difficulties with sleep, worry, fatigue, and sometimes mood. FOCUS uses cognitive-behavioral and acceptance and commitment therapy strategies designed to improve these symptoms. Cognitive-behavioral therapy is a type of counseling focused on how the ways that people think (cognitive) and what they do (behavioral) can change the way they feel. Acceptance and commitment therapy is an intervention which has demonstrated success in treating symptoms by teaching strategies to focus time and energy on valued activities despite symptoms. This may be an effective way for patients with advanced cancer to manage their symptoms.
Additional locations may be listed on ClinicalTrials.gov for NCT07102212.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Approved
Contact: Sharla Wells-DiGregorio
Phone: 614-499-2495
PRIMARY OBJECTIVES:
I. Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer.
II. Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and gender.
EXPLORATORY OBJECTIVE:
I. Examine biobehavioral mediators of treatment effects.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete four FOCUS modules covering symptoms of insomnia, worry-anxiety, fatigue, and mood over 1-1.5 hours each over 6 weeks. Patients also receive professional support via telemedicine over 15-20 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study.
ARM II: Patients complete four standardized National Cancer Institute (NCI) modules covering symptoms of sleep, worry, fatigue, and mood over 6 weeks. Patients also receive standardized support via telemedicine over 15-20 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up at 12 weeks and 6 and 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSharla Wells-DiGregorio
