@Article{info:doi/10.2196/58938,
author="Fraterman, Itske
and Sacchi, Lucia
and Mallo, Henk
and Tibollo, Valentina
and Glaser, Savannah Lucia Catherina
and Medlock, Stephanie
and Cornet, Ronald
and Gabetta, Matteo
and Hisko, Vitali
and Khadakou, Vadzim
and Barkan, Ella
and Del Campo, Laura
and Glasspool, David
and Kogan, Alexandra
and Lanzola, Giordano
and Leizer, Roy
and Ottaviano, Manuel
and Peleg, Mor
and {\'{S}}niata{\l}a, Konrad
and Lisowska, Aneta
and Wilk, Szymon
and Parimbelli, Enea
and Quaglini, Silvana
and Rizzo, Mimma
and Locati, Laura Deborah
and Boekhout, Annelies
and van de Poll-Franse, Lonneke V
and Wilgenhof, Sofie",
title="Exploring the Impact of the Multimodal CAPABLE eHealth Intervention on Health-Related Quality of Life in Patients With Melanoma Undergoing Immune-Checkpoint Inhibition: Prospective Pilot Study",
journal="JMIR Cancer",
year="2025",
month="Jan",
day="30",
volume="11",
pages="e58938",
keywords="eHealth; melanoma; cancer; fatigue; quality of life; intervention; pilot study; exploratory; health-related; interventions; symptom; monitoring; well-being; immunotherapy; immune-related; immune-checkpoint inhibitor; patient; feasibility; smartphone; app; smartwatch; linear regression model; mobile phone",
abstract="Background: Patients with melanoma receiving immunotherapy with immune-checkpoint inhibitors often experience immune-related adverse events, cancer-related fatigue, and emotional distress, affecting health-related quality of life (HRQoL) and clinical outcome to immunotherapy. eHealth tools can aid patients with cancer in addressing issues, such as adverse events and psychosocial well-being, from various perspectives. Objective: This study aimed to explore the effect of the Cancer Patients Better Life Experience (CAPABLE) system, accessed through a mobile app, on HRQoL compared with a matched historical control group receiving standard care. CAPABLE is an extensively tested eHealth app, including educational material, remote symptom monitoring, and well-being interventions. Methods: This prospective pilot study compared an exploratory cohort that received the CAPABLE smartphone app and a multisensory smartwatch for 6 months (intervention) to a 2:1 individually matched historical prospective control group. HRQoL data were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at baseline (T0), 3 months (T1), and 6 months (T2) after start of treatment. Mixed effects linear regression models were used to compare HRQoL between the 2 groups over time. Results: From the 59 eligible patients for the CAPABLE intervention, 31 (53{\%}) signed informed consent to participate. Baseline HRQoL was on average 10 points higher in the intervention group compared with controls, although equally matched on baseline and clinical characteristics. When correcting for sex, age, disease stage, and baseline scores, an adjusted difference in fatigue of −5.09 (95{\%} CI −15.20 to 5.02, P=.32) at month 3 was found. No significant nor clinically relevant adjusted differences on other HRQoL domains over time were found. However, information satisfaction was significantly higher in the CAPABLE group ($\beta$=8.71, 95{\%} CI 1.54‐15.88, P=.02). Conclusions: The intervention showed a limited effect on HRQoL, although there was a small improvement in fatigue at 3 months, as well as information satisfaction. When aiming at personalized patient and survivorship care, further optimization and prospective investigation of eHealth tools is warranted. Trial Registration: ClinicalTrials NCT05827289; https://clinicaltrials.gov/study/NCT05827289 International Registered Report Identifier (IRRID): RR2-10.2196/49252 ",
issn="2369-1999",
doi="10.2196/58938",
url="https://cancer.jmir.org/2025/1/e58938",
url="https://doi.org/10.2196/58938"
}