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

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Jul 24, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new program called FOCUS, designed to help people with advanced cancer manage common symptoms like trouble sleeping, anxiety, depression, and fatigue (extreme tiredness). The program combines proven therapy techniques to teach skills that help patients feel better and focus on what matters most in their lives, despite these symptoms. The program is delivered through telemedicine and a mobile app, making it easy to access from home. Early studies showed that FOCUS helped improve sleep and reduce worry, depression, and fatigue for up to a year after treatment.

People who might join this study include adults (18 years and older) with advanced lung, breast, prostate cancer, multiple myeloma, or melanoma, who are experiencing at least two of these symptoms at a certain level. Participants need to be comfortable using the internet and email since the program is online. The study aims to include people from rural and Appalachian communities. If you join, you will learn ways to manage your symptoms using the app and remote support, which could help improve your quality of life while living with advanced cancer.

Gender

ALL

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 Health Proficiency Questionnaire.
• • People with stage IIIb\&c/IV lung cancer,
• • Stage IV breast cancer,
• • Stage IV prostate cancer
• • Advanced (on active treatment) multiple myeloma
• • Stage IIIb \& IV melanoma (24 of each cancer type) who 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 will be asked to participate
• Exclusion Criteria:
• • Night-shift work
• • Untreated bipolar disorder
• • Substance abuse
• • 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),
• • \<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.