Beta Testing an mHealth Symptom Management Intervention for People With Advanced Cancer: Single-Cohort Feasibility and Acceptability Study.

Abstract

Background: People living with advanced cancer experience more frequent and severe symptoms than those with early-stage disease. Common, distressing symptoms include sleep difficulties, worry and uncertainty, fatigue, and depression. Cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) effectively manage these symptoms but are often too time intensive for patients with multiple appointments, limited energy, and competing priorities. Brief, mobile health (mHealth) interventions provide an accessible alternative, particularly for rural patients with limited access to palliative or psychosocial oncology services.

Objective: Building on our successful in-person and Digital Video Disk-based pilot trial of a 3-session, integrated CBT-ACT symptom management intervention for patients with advanced cancer, Finding Our Center Under Stress (FOCUS), the current study evaluated the feasibility and acceptability of a 4-session mHealth version.

Methods: In this single-cohort feasibility and acceptability study, people with advanced cancer were recruited from hospital-based oncology clinics representing 4 cancer types (breast, melanoma, multiple myeloma, and prostate). Baseline assessments included sociodemographic data, patient-reported outcomes for sleep (Insomnia Severity Index), anxiety (7-item Generalized Anxiety Disorder scale and Penn State Worry Questionnaire), fatigue (Fatigue Symptom Inventory), depression (Center for Epidemiological Studies Depression Scale), and a 7-day sleep diary completed in the app. Participants then completed 4 modules addressing sleep difficulties, worry and uncertainty, fatigue, and depression. Primary outcomes were feasibility and acceptability. Feasibility benchmarks included recruitment (50% enrollment), retention (70%), and app completion (50%). After 6 weeks, participants completed the Internet Evaluation and Utility Questionnaire, and a subset completed qualitative interviews about their experience with the FOCUS app. We report quantitative and qualitative findings and lessons learned from app development.

Results: Overall, 64.7% (11/17) of the approached patients enrolled, and 70% (7/10) completed more than half of the app. Participants rated FOCUS highly for ease of understanding (mean 3.83/4, SD 0.41), convenience (mean 3.67/4, SD 0.82), and utility (mean 3.33/4, SD 0.82). All participants would recommend the app to others and would use it again for future problems. Favorite components included patient videos and the Sleep and Worry and Uncertainty Modules. Suggested improvements included video quality (lighting and sound), sleep diary usability, and additional professional guidance.

Conclusions: The FOCUS intervention was successfully delivered via mobile technology and demonstrated feasibility and acceptability in beta testing. The FOCUS mHealth app offers an evidence-based, accessible symptom management intervention for people with advanced cancer, particularly in rural communities. Guided by participant feedback, FOCUS 2.0 will enhance video segments, add telehealth support, and expand interactive and motivational features. A randomized controlled trial will evaluate its effectiveness.