Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Center Under Stress (FOCUS)
FOCUS
Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas
3 other identifiers
interventional
120
1 country
1
Brief Summary
In response to the symptom needs experienced in advanced cancer, the investigators developed a brief, integrated CBT-ACT symptom management intervention, Finding Our Center Under Stress (FOCUS). Using FOCUS, participants learn skills to self-manage sleep, worry-anxiety, depression, and fatigue and improve their ability to focus on what matters most to them despite these symptoms. Results of the pilot randomized controlled trial with people with advanced cancer demonstrate improved sleep on both self-report and physiologic (i.e., actigraphy) measures, and improvements on worry, depression, and fatigue interference with strong effect sizes ranging from d= 0.59 to 0.98 and sleep effects 12 months post-treatment. The investigators refined the fatigue module with exercise modifications and beta-tested the FOCUS intervention as an mHealth web-based app for acceptability with 10 diverse patients with advanced cancer -100% would recommend for other advanced cancer patients. The overall objective of this proposed randomized effectiveness trial is to evaluate the impact of this telemedicine-mHealth symptom cluster intervention with patients from rural and Appalachian communities (where the PI was raised). Innovative features include a focus on a symptom cluster including anxiety, integrated CBT-ACT intervention, telemedicine-mHealth delivery method, and biobehavioral approach evaluating behavioral and inflammatory mediators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lung-cancer
Started Feb 2026
Typical duration for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
December 24, 2025
December 1, 2025
2.6 years
July 16, 2025
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Insomnia Severity Index
Symptom measures of insomnia will be made using the Insomnia Severity Index, a scale from 0 to 28 with higher scores indicating greater insomnia
Baseline, 6 and 12 weeks, and 6 and 12 months
Center for Epidemiological Studies Depression Scale
Symptom measures of depression will be made using the Center for Epidemiological Studies Depression Scale, a scale from 0 to 60 with higher scores indicating more depressive symptoms/more severe depression
Baseline, 6 and 12 weeks, and 6 and 12 months
Fatigue Severity Index
Symptom measures of fatigue will be made using the Fatigue Severity Index, a scale from 0 to 110 with higher scores indicating more severe fatigue
Baseline, 6 and 12 weeks, and 6 and 12 months
Generalized Anxiety Disorder
Symptom measures of generalized anxiety will be made using the Generalized Anxiety Disorder - 7 (GAD-7), a scale from 0 to 21with higher scores indicating more severe anxiety
Baseline, 6 and 12 weeks, and 6 and 12 months
App Dose and Use
The investigators will analyze usage reports of participant engagement with FOCUS mHealth application to assess time reviewing the four FOCUS modules (sleep, worry, depression, fatigue) and overall time using the application to evaluate dose-response on symptoms. The investigators will compare FOCUS usage by geographic location (rural vs other) and demographics and complete detailed examination of clickmaps, screen recordings, and module usage.
Up to 12 months
Symptom Interference/Quality of Life
The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) five functional sub-scales to assess symptom interference. The subscales will be totaled and the overall scale will range from 0 to 110 with higher scores on functional scales and global health status/quality of life representing better functioning.
Baseline, 6 and 12 weeks, 6 and 12 months
Secondary Outcomes (3)
Biobehavioral Mediators
Baseline, 6 and 12 weeks, and 6 and 12 months
CAQ-8 (Committed Action Questionnaire)
Up to 12 months
AAQ-II (Acceptance and Action Questionnaire)
Up to 12 months
Study Arms (2)
FOCUS Intervention Arm
EXPERIMENTALFOCUS is a standardized mHealth-integrated CBT-ACT biobehavioral intervention divided into four modules. FOCUS includes an introductory video, sleep diary, app overview and a sleep module, worry-uncertainty module, fatigue module, and a mood module (each 1.5 hours spread over a week), for a total of 6 hrs of direct mHealth intervention (not including home practice time) spaced across 6 wks. All modules include behavioral and values-based exercises. The app also features motivational features/rewards for skill-based home practice activities. FOCUS Telemedicine Component. Psychosocial Oncology Fellows (Ph.D. clinical psychologists) will provide minimal contact professional support, connecting with participants via telemedicine for 15-20 min each week to answer questions about skills and home practice after each module. Our project coordinator will respond to any technical or study issues with Moby support, our mobile app design team.
Information Control Arm
SHAM COMPARATORParticipants will be randomly assigned to an area of the mHealth app specific for control participants. This section of the app will contain a similar video introduction and instructions for use of the app followed by four symptom modules - sleep, worry, fatigue, and mood containing standardized patient information from NCI for each symptom. Control Group Telemedicine Component. Participants will receive weekly minimal contact with a postdoctoral fellow who will assess understanding of NCI symptom management materials with standardized questions focused on that week's material, note information to be reviewed the following week, answer any study-related questions, and record any symptom management practices initiated since reviewing these materials.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State University Comprehensive Cancer Centerlead
- Ohio Universitycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Wells-Di Gregorio SM, Marks DR, DeCola J, Peng J, Probst D, Zaleta A, Benson D, Cohn DE, Lustberg M, Carson WE, Magalang U. Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer. Psychooncology. 2019 Jan;28(1):76-84. doi: 10.1002/pon.4912. Epub 2018 Oct 30.
PMID: 30335211BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharla Wells-Di Gregorio, PhD
Ohio State University Comprehensive Cancer Center
Central Study Contacts
The Ohio State University Comprehensive Cancer Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- This is a prospective, tripleblind (i.e., patient, research assistant, statistician), single-site, randomized, clinical effectiveness trial of a brief, tailored, minimal contact telemedicine-mHealth symptom management intervention for people with advanced cancer from rural areas.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 16, 2025
First Posted
August 3, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
September 30, 2029
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
- Time Frame
- The investigators will release data in "waves" relating to publications deriving from this data. For instance, our trial sleep data will be released after Aim 1 is published, our immunology data after Aim 3 is published, and all other data will be available after study is completed via Cancer Data Services. Data will remain available for 15 years. After this time, treatment advances may affect how these diseases are treated and/or symptoms are addressed.
- Access Criteria
- Researchers with certified training in human subjects protections will be able to request access. The investigators will utilize a data sharing agreement that requires 1) a commitment to using the data and codebook only for research purposes, 2) a commitment to securing the data via appropriate computer technology, and 3) a commitment to destroying or returning the data after analyses are complete.
Per NIH Data Sharing Policy, data from this project, including questionnaire data, de-identified demographics and disease information, as well as biomarker data will be shared at the completion of the study via computerized dataset. The investigators do not plan to release data pertaining to participants' individual web-usage as this data is believed to be private and not essential to the overarching purposes or goals of the project. However, the investigators will release summary statistics pertaining to usage (total app usage, frequency of home practice) so Aim 2 of this study can be evaluated by others interested in the web-usage and descriptive features of the study. A study codebook will be provided outlining the methodology and procedures used to collect the data, variable definitions and labels, scored variable information, and information on the general structure/timepoint labeling of the available data.