TY  - JOUR
AU  - Fraterman, Itske
AU  - Sacchi, Lucia
AU  - Mallo, Henk
AU  - Tibollo, Valentina
AU  - Glaser, Savannah Lucia Catherina
AU  - Medlock, Stephanie
AU  - Cornet, Ronald
AU  - Gabetta, Matteo
AU  - Hisko, Vitali
AU  - Khadakou, Vadzim
AU  - Barkan, Ella
AU  - Del Campo, Laura
AU  - Glasspool, David
AU  - Kogan, Alexandra
AU  - Lanzola, Giordano
AU  - Leizer, Roy
AU  - Ottaviano, Manuel
AU  - Peleg, Mor
AU  - Śniatała, Konrad
AU  - Lisowska, Aneta
AU  - Wilk, Szymon
AU  - Parimbelli, Enea
AU  - Quaglini, Silvana
AU  - Rizzo, Mimma
AU  - Locati, Laura Deborah
AU  - Boekhout, Annelies
AU  - van de Poll-Franse, Lonneke V
AU  - Wilgenhof, Sofie
PY  - 2025
DA  - 2025/1/30
TI  - 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
JO  - JMIR Cancer
SP  - e58938
VL  - 11
KW  - eHealth
KW  - melanoma
KW  - cancer
KW  - fatigue
KW  - quality of life
KW  - intervention
KW  - pilot study
KW  - exploratory
KW  - health-related
KW  - interventions
KW  - symptom
KW  - monitoring
KW  - well-being
KW  - immunotherapy
KW  - immune-related
KW  - immune-checkpoint inhibitor
KW  - patient
KW  - feasibility
KW  - smartphone
KW  - app
KW  - smartwatch
KW  - linear regression model
KW  - mobile phone
AB  - 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 (β=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 
SN  - 2369-1999
UR  - https://cancer.jmir.org/2025/1/e58938
UR  - https://doi.org/10.2196/58938
DO  - 10.2196/58938
ID  - info:doi/10.2196/58938
ER  -