An eHealth App (CAPABLE) Providing Symptom Monitoring, Well-Being Interventions, and Educational Material for Patients With Melanoma Treated With Immune Checkpoint Inhibitors: Protocol for an Exploratory Intervention Trial (Preprint)

Abstract

BACKGROUND Since treatment with immune-checkpoint inhibitors (ICIs) is becoming standard therapy for high-risk and advanced-melanoma patients, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools in providing either symptom monitoring or interventions to reduce treatment-related symptoms like fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management is still needed. OBJECTIVE In this pilot study, we will explore the use of the Cancer Patients Better Life Experience (CAPABLE) application in providing symptom monitoring, education and wellbeing interventions, on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients’ acceptance of using a system like CAPABLE. METHODS This prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III/IV melanoma during treatment with ICI using the CAPABLE intervention (a smartphone application and a multi-sensorial smartwatch). This cohort will be compared to a prospectively collected cohort of melanoma patients treated with standard ICI therapy. The CAPABLE application and smartwatch will be used for a minimum of three and a maximum of six months. The primary endpoint in this study is the change in fatigue between baseline, 3 and 6 months after start of treatment. Secondary endpoints include other HRQoL outcomes, usability and feasibility parameters. RESULTS Study inclusion started in April 2023 and is currently ongoing. CONCLUSIONS This pilot study will explore the effect, usability and feasibility of the CAPABLE system in melanoma patients during treatment with ICI. This study will be the first to provide a system developed in collaboration with patients and clinicians that includes symptom monitoring, information provision and wellbeing interventions in one eHealth tool. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study under reference number 22-981/NL81970.000.22. CLINICALTRIAL Trial registration number: NCT05827289