Exploring the impact of the multimodal CAPABLE eHealth intervention on health-related quality of life in melanoma patients undergoing immune-checkpoint inhibition: A prospective pilot study
ABSTRACT
Background:
Patients with melanoma receiving immunotherapy with immune-checkpoint inhibitors (ICIs) often experience immune-related adverse events (AEs), cancer-related fatigue and emotional distress, affecting health-related quality of life (HRQoL) and clinical outcome to immunotherapy. EHealth tools can aid cancer patients in addressing issues such as AEs and psychosocial well-being from various perspectives.
Objective:
We explored the effect and feasibility of the CAPABLE system, accessed via a mobile application, on HRQoL compared to a matched historical control group receiving standard care. CAPABLE is an extensively tested eHealth application, 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 was measured with the EORTC QLQ-C30 at baseline (T0), 3 (T1), and 6 months (T2) after start of treatment. Mixed effects linear regression models were used to compare HRQoL between the two groups over time.
Results:
From eligible patients (n=59) for the CAPABLE intervention, 31 (53%) signed informed consent to participate. Intervention and control group were equally balanced on baseline and clinical characteristics. Baseline HRQoL was on average 10 points higher in the intervention group. When correcting for sex, age, disease stage, and baseline scores, we observed no significant nor clinically relevant adjusted differences on HRQoL over time. However, information satisfaction was significantly higher in the CAPABLE group.
Conclusions:
The intervention showed no effect on HRQoL, although there was a small improvement in fatigue at 3 months, as well as information satisfaction. A low participation rate and ceiling effects due to substantially higher baseline HRQoL in the intervention group may have limited the detectable effect. When aiming at personalized patient and survivorship care, further optimization and prospective investigation of eHealth tools is warranted. Clinical Trial: NCT05827289
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