NCT07102212 · RECRUITING
Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Center Under Stress (FOCUS)
This trial is testing a smartphone and video-based program called FOCUS that uses two talk-therapy approaches, cognitive-behavioral therapy and acceptance and commitment therapy, to help people with advanced cancer manage sleep problems, anxiety, fatigue, and low mood. It is a Phase N/A trial, meaning it is evaluating how well this behavioral program works in practice rather than testing a drug. Researchers are enrolling 120 adults across five cancer types.
Eligibility criteria
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-18