Abstract 873P
Background
Ambulatory monitoring using wearable devices combined with online symptom monitoring in a home-based setting could improve quality of care for patients during imunotherapy. The aim of this study was to evaluate the feasibility of the online CAMP-IT platform and explore the first results of the Fitbit and patient-reported outcome (PRO) data generated by the platform.
Methods
Consenting patients with advanced melanoma, scheduled to receive treatment with immune checkpoint inhibitors (ICIs) were connected to the platform consisting of Fitbit, smart thermometer, and smartphone app for 12 weeks after start of ICIs. Participants were asked to complete a weekly PRO-CTCAE survey (15 items) in the app, take daily temperature measurements and wear the Fitbit continuously. Weekly averages of Fitbit-measured daily steps were calculated and changes over time were analyzed using linear mixed effect models. Feasibility was determined in terms of compliance rates with questionnaires and temperature measurements (> 75%) and for Fitbit use recording at least 100 steps for at least 75% of assigned days. At follow-up, satisfaction was scored on a 0-10 scale.
Results
A total of 41 out of 44 eligible patients were included. Median age was 59 (range 30-74) years and 51% was female. Metastatic disease was present in 44% of patients and 32% received combination ICI therapy. Mean compliance with temperature measurements, PRO-CTCAE surveys and Fitbit was 76%, 86%, and 96%, resp. Mean daily steps in week 1 was 6997 (SD 3306) and did not decrease significantly over time (p =0.72). Grade 3 AEs occurred in 43% of patients and the most commonly reported grade 3 AEs were fatigue (30%), headache (20%), and shortness of breath (15%). Presence of grade 3 AEs was accompanied with significant lower activity levels in matching weeks compared with absence (median steps: 5269 vs 7911, resp., p <0.001). Overall satisfaction rating was 7.5.
Conclusions
The use af a comprehensive ambulatory monitoring platform is feasible and acceptable in patients receiving ICIs for advanced melanoma. Combining objective data from wearable devices with PROs offers new possibilities in ambulatory monitoring of AEs. Future studies should examine their value in early detection of AEs.
Clinical trial identification
NL8827 (21-08-2020).
Editorial acknowledgement
Legal entity responsible for the study
Amsterdam UMC.
Funding
Bristol Myers Squibb.
Disclosure
All authors have declared no conflicts of interest.