'Cancer Patients Better Life Experience' (CAPABLE)

Netherlands Cancer Institute (NKI)

Status

Enrolling

Conditions

Melanoma

Treatments

Device: Cancer Patients Better Life Experience (CAPABLE)

Study type

Interventional

Funder types

Other

Identifiers

NCT05827289

NL81970.000.22 (Other Identifier)

P22BLE

Details and patient eligibility

About

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.

Full 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).

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

>18 years of age
Sufficient understanding of the Dutch language
Participants or their caregiver can use a smartphone (upon patient's consent)
Histologically confirmed stage III or IV melanoma who receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines.

Exclusion criteria