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

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 PRIMARY OBJECTIVES: I. Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer. II. Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and gender. EXPLORATORY OBJECTIVE: I. Examine biobehavioral mediators of treatment effects. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients complete four FOCUS modules covering symptoms of insomnia, worry-anxiety, fatigue, and mood over 2-2.5 hours each over 6 weeks. Patients also receive professional support via telemedicine over 20-30 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study. ARM II: Patients complete four standardized National Cancer Institute (NCI) modules covering symptoms of sleep, worry, fatigue, and mood over 6 weeks. Patients also receive standardized support via telemedicine over 20-30 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study. After completion of study intervention, patients are followed up at 12 weeks and 6 and 12 months.