No registrations found.
ID
Source
Brief title
Health condition
melanoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The emergence of immune checkpoint inhibitors has improved survival outcomes for patients with advanced melanoma. However, these treatment modalities are also associated with specific immune-related toxicities. These are often reversible after prompt recognition and initiation of appropriate management, but can result in severe morbidity and hamper health-related quality of life (HRQoL) if left undetected. Hence, accurate and regular monitoring of these patients is critical. Recent advances in mHealth technologies and the rapidly expanding armamentarium of wearable devices allow for real-time objective (vital signs and physical activity) data and patient-reported outcome measurement (PROMs) collection and, hence, serve this purpose. We hypothesize that collection of real-time objective data adds to the early detection of disease- and treatment-related adverse events. The primary objective of this study is to determine the feasibility of collecting real-time PROMs, vital signs, and physical activity data in advanced melanoma patients receiving immunotherapy using a comprehensive ambulatory monitoring platform (CAMP) that consists of a smartphone app, activity monitor, digital thermometer, and online dashboard for physicians. In this prospective multi-center trial, patients (n=50) with advanced melanoma, scheduled to receive immunotherapy with immune checkpoint inhibitors, and with access to a smartphone are eligible for inclusion. Consenting patients will be asked to wear a FitBit Versa 2.0 during waking hours, collect daily temperature measurements using a Withings Smart Temporal thermometer, and answer weekly toxicity questionnaires (NCI PRO-CTCAE) using the smartphone app for the duration of the study (12 weeks). Primary outcome is 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 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.
Study objective
It is feasibility to collect activity data, vital signs, and PROMS using a comprehensive online monitoring platform that consists of a wearable activity monitor, digital thermometer, and smartphone-app in patients with advanced melanoma undergoing immunotherapy.
Study design
T0: start immunotherapy and connection to the Comprehensive online monitoring platform
T1: (+6weeks) mid-study
T2: (+12 weeks) end-of-study
T3: (+1 year)
Intervention
Comprehensive ambulatory monitoring platform
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
• 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8827 |
| Other | METC AMC : W20_254 # 20.289 |