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

The Ohio State University

Status: Not yet enrolling

Conditions: Breast Cancer; Melanoma; Multiple Myeloma; Lung Cancer; Prostate Cancer

Treatments: Behavioral: mHealth Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07102212

NCI-2025-05185 (Other Identifier)

OSU-24212

R01CA281885 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

FOCUS Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: mHealth Intervention

Information Control Arm

Sham Comparator group

Description:

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.

Treatment:

Behavioral: mHealth Intervention