melanoma
Conditions
Interventions
Comprehensive ambulatory monitoring platform
Sponsors
Amsterdam UMC, location AMC, Amsterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: • >18 years • scheduled to receive immunotherapy with ipilimumab, nivolumab, or pembrolizumab • Ambulatory without use of walking aids • Access to device that has the capability to sync the wearable activity monitor and digital thermometer • Proper understanding of the Dutch language • Have an understanding, ability, and willingness to fully comply with study procedures and restrictions • Ability to consent
Exclusion criteria
Exclusion criteria: • History of allergy to surgical steel or elastomer/rubber • Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants, or other electronic medical equipment • Permanent or temporary changes to the skin of the wrist (e.g. tattoos, scar tissue) that might impact heart rate sensor performance • Incapability to use digital devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility in terms of (i) participation rates, (ii) wear-time, (iii) compliance rates with in-app questionnaires and temperature measurements, and (iv) satisfaction with the platform. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary exploratory outcomes include associations between CAMP-derived parameters and clinical outcomes: performance status (PS), HRQoL (EORTC QLQ-C30), unplanned hospitalizations, adverse events, and 1-year survival outcomes. PS and HRQoL will be rated at baseline, mid-study, and end-of-study. The occurrence of disease- and treatment-related adverse events will be documented up to 12 months from baseline. Survival outcomes will be compared to a propensity score matched group from the Netherlands Cancer Registry. | — |
Contacts
Public ContactMilan Kos
Amsterdam UMC
Outcome results
None listed