Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Cente… (NCT07102212) | Clinical Trial Compass
SuspendedNot Applicable
Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Center Under Stress (FOCUS)
Stopped: pending amendment
United States120 participantsStarted 2026-06-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1I see this trial is currently listed as suspended — do you know why it's paused, and whether it might reopen to new patients in the future?
2This study is focused on managing a cluster of symptoms like insomnia, fatigue, anxiety, and depression through a telemedicine and mobile health app — given my specific diagnosis, do you think my symptom burden matches what this trial is designed to address?
3Since this is a Phase NA behavioral intervention rather than a drug trial, what does that mean for what's already known about its safety, and how does it compare to symptom management support I could access right now outside of a trial?
4The trial measures how much participants actually use the app as a primary outcome — can you help me think through whether the technology and time commitment involved would realistically fit into my day-to-day life during treatment?
5Are there standard palliative care or integrative oncology programs available to me now that address these same symptoms — insomnia, fatigue, anxiety, and depression — while this trial remains suspended?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insomnia Severity Index
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
2
Center for Epidemiological Studies Depression Scale
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
3
Fatigue Severity Index
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
4
Generalized Anxiety Disorder
Timeframe: Baseline, 6 and 12 weeks, and 6 and 12 months
5
App Dose and Use
Timeframe: Up to 12 months
6
Symptom Interference/Quality of Life
Timeframe: Baseline, 6 and 12 weeks, 6 and 12 months
Trial details
NCT IDNCT07102212
SponsorOhio State University Comprehensive Cancer Center