Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 22, 2021
Date Accepted: Nov 10, 2021
Clinical validation of a remote monitoring system (ONCO-TreC) to optimize the home management of oral anticancer therapies
ABSTRACT
Background:
ONCO-TreC, a platform designed to support the home management of anticancer oral treatments and to provide a secure online patient-healthcare professional communication modality, was tested in 3 cancer centers in Italy.
Objective:
The overall aims of the trial were to customize the platform, assess the system’s ability to facilitate the shared management of oral anticancer therapies by patients and health professionals, and evaluate system usability and acceptability by patients, caregivers and healthcare professionals.
Methods:
Patients ≥18 years old who were candidates for anticancer oral treatment as monotherapy, with an ECOC PS 0-1 and a sufficient level of familiarity with mobile devices, were eligible. Forty patients were enrolled, and adherence was >86%.
Results:
The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95 CI: 86.1%-99.9%) between investigator and system pill count. Only 60.0% of grade (G)3, 54.1% of G2 and 19.4% of G1 adverse events reported by physicians in Case Report Forms were also reported in the mobile application (APP) directly by patients. 94.2% of patients had at least one APP launch each week, and the median number of daily accesses per patient was 2. Twenty-seven (77.1%) and 26 patients (74.2%) used the application for messages and vital sign entering, respectively, at least once during the study period.
Conclusions:
ONCO-TreC was an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved. Clinical Trial: ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724
Citation
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