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
Ohio State University Comprehensive Cancer Center
120 participants
Jun 15, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- Participants will include 120 people with advanced cancer who are ≥ 18 yrs old
- Able to read and write in English
- Who use internet and e-mail as determined by Computer \& Mobile Device Proficiency Questionnaire.
- People with stage IIIb\&c/IV lung cancer, stage IV breast cancer, stage IV prostate cancer, advanced (on active treatment) multiple myeloma, and stage IIIb \& IV melanoma (24 of each cancer type)
- meet clinical cut-offs on any two symptoms in this cluster (i.e., ≥ 8 on Insomnia Severity Index (ISI), ≥ 3 on Patient Health Questionnaire-2 for depression, ≥ 2 on Generalized Anxiety Disorder-2, ≥ 3 on Fatigue Symptom Inventory Severity)
Exclusion Criteria6
- Night-shift work
- Untreated bipolar disorder
- Substance use disorder
- Cognitive impairment per Brief Screen for Cognitive Impairment
- Eastern Cooperative Oncology Group performance status of 3 or greater (in bed 50% or more of day), or <6 mos predicted survival per oncology team.
- Prior participation in cognitive behavior therapy will not be an exclusion criterion if individuals meet symptom severity threshold for at least two symptoms.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07102212