Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Center Under Stress (FOCUS)
- Conditions
- Lung CancerMultiple MyelomaBreast CancerProstate CancerMelanoma
- Registration Number
- NCT07102212
- 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.
- Detailed 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Insomnia Severity Index Baseline, 6 and 12 weeks, and 6 and 12 months Symptom measures of insomnia will be made using the Insomnia Severity Index, a scale from 0 to 28 with higher scores indicating greater insomnia
Generalized Anxiety Disorder Baseline, 6 and 12 weeks, and 6 and 12 months 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
App Dose and Use Up to 12 months 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.
Center for Epidemiological Studies Depression Scale Baseline, 6 and 12 weeks, and 6 and 12 months 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
Fatigue Severity Index Baseline, 6 and 12 weeks, and 6 and 12 months 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
Symptom Interference/Quality of Life Baseline, 6 and 12 weeks, 6 and 12 months 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.
- Secondary Outcome Measures
Name Time Method Biobehavioral Mediators Baseline, 6 and 12 weeks, and 6 and 12 months The investigators will test whether symptom severity is mediated by stress hormones (cortisol) and inflammation (IL-12, IL-1alpha, IL-1beta, TNF-alpha, TNFbeta, IL-6, hsCRP) by measuring the levels of each biomarker at various time points throughout the study.
CAQ-8 (Committed Action Questionnaire) Up to 12 months The investigators will test whether symptom severity is mediated by behavioral changes (committed action - Committed Action Questionnaire). The CAQ-8 scale ranges from 0 to 48 with higher levels indicating a more committed action.
AAQ-II (Acceptance and Action Questionnaire) Up to 12 months The investigators will test whether symptom severity is mediated by behavioral changes (psychological flexibility - Acceptance and Action Questionnaire). The AAQ-II scale ranges from 7 to 49 with higher scores representing greater psychological inflexibility. This measure will be reverse scored so that higher scores represent greater psychological flexibility to test the mediator hypothesis.
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Ohio State University Comprehensive Cancer Center🇺🇸Columbus, Ohio, United StatesSharla Wells-Di GregorioPrincipal Investigator