Comprehensive ambulatory monitoring during immunotherapy in patients with advanced melanoma: a prospective trial (CAMP-IT)

Recruiting

• Conditions: melanoma

• Registration Number: NL-OMON22326
• Lead Sponsor: Amsterdam UMC, location AMC, Amsterdam, The Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.