MedDataX Logo

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

NCT ID: NCT07102212

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2029-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will deliver an evidence-based intervention for a common cancer symptom cluster, with clinically significant pilot findings, to rural, underserved people with advanced cancer. The investigators will improve access via a telemedicine- mHealth approach, developed and refined based on the needs and evaluative feedback of people with advanced cancer. The investigators aim to reduce symptom severity and interference via an integrated CBT-ACT intervention. In addition, the investigators will examine the behavioral, hormonal, and inflammatory mechanisms of symptom change including several novel biomarkers identified in the pilot trial (e.g., IL-12, IL-1alpha, TNFbeta). An effective, accessible, brief alternative to medication-based symptom cluster management is essential given the limited availability of palliative and psychosocial care for this population and impact of these symptoms on patient functional status, quality of life, treatment adherence, and survival. The study aligns with NCI's goal to enhance access to clinical trials via telemedicine and mobile applications to better meet the survivorship needs of underserved populations and the goal of RFA CA-22-027 to test interventions to improve delivery of comprehensive survivorship care for individuals with advanced cancer.

SPECIFIC AIMS:

Aim 1: Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer

Aim 2: Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and other demographics

Aim 3 (Exploratory): Examine biobehavioral mediators of treatment effects

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Breast Cancer Prostate Cancer Multiple Myeloma Melanoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

symptom management cancer rural sleep anxiety worry fatigue mood depression mHealth telemedicine app advanced cancer Appalachian

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The overall goal of this randomized clinical trial is to evaluate the effectiveness of a telemedicine-mHealth symptom cluster intervention, Finding Our Center Under Stress (FOCUS), with people with advanced cancer. The investigators include a telemedicine-mHealth information control condition for comparison.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FOCUS Intervention Arm

FOCUS 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.

Group Type EXPERIMENTAL

mHealth Intervention

Intervention Type BEHAVIORAL

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.

Information Control Arm

Participants 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.

Group Type SHAM_COMPARATOR

mHealth Intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mHealth Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ohio University

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sharla Wells-Di Gregorio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sharla Wells-Di Gregorio, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

The Ohio State University Comprehensive Cancer Center

Role: CONTACT

Phone: 800-293-5066

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sharla Wells-Di Gregorio

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30335211 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://psychosocialoncology.wixsite.com/focus

FOCUS study website

http://cancer.osu.edu

Information about the James Cancer Hospital and Solove Research Institute

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2025-05185

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA281885

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-24212

Identifier Type: -

Identifier Source: org_study_id