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Clinical Trial Summary

The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). It is expected that by using the CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.


Clinical Trial Description

This is a prospectively enrolling, explorative cohort study in melanoma patients, eligible for or on treatment with ICI therapy. The explorative cohort receives the CAPABLE smartphone application and a multi-sensorial smartwatch. Patients will be asked to use the system for minimum of three to maximum of six months after enrolment. Questionnaires on health-related quality of life (such as fatigue) and user experience will be administered to the patients on baseline/before start treatment (T0), three months (T1) and six months (T2). Results of this interventional study will be compared with a historical cohort consisting of melanoma patients (P20MEL; NL75996.031.20) with the same inclusion criteria as this study population, but receiving standard care (e.g. without the CAPABLE app). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05827289
Study type Interventional
Source The Netherlands Cancer Institute
Contact Itske Fraterman, MSc
Phone +31205122036
Email i.fraterman@nki.nl
Status Recruiting
Phase N/A
Start date April 15, 2023
Completion date December 31, 2023

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