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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07102212
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ohio State University Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sharla Wells-Di Gregorio, PhD
Principal Investigator Affiliation	Ohio State University Comprehensive Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Cancer, Breast Cancer, Prostate Cancer, Multiple Myeloma, Melanoma
Study Website:	View Trial Website

Additional Details

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

Arms & Interventions

Arms

Experimental: 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.

Sham Comparator: 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.

Interventions

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbus 4509177, Ohio 5165418

Status

Address

Ohio State University Comprehensive Cancer Center

Columbus 4509177, Ohio 5165418, 43210

Site Contact

Sharla Wells-Di Gregorio

[email protected]

800-293-5066

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