Abstract
Background and methodsE-health solutions are a promising tool to assist patients in self-managing symptoms for various diseases. This study aimed to assess the feasibility, reliability, usability, and satisfaction of a digital medical device (ZEMY) for patients’ self-monitoring of symptoms commonly experienced during breast cancer treatment and to enhance interaction with healthcare professionals. In this open-label, interventional, multicentre, single-arm clinical trial (NCT03558490), patients at all stages of breast cancer initiating oral and/or parenteral treatment were recruited at initiation of therapy and followed for 3 months. During treatment, the patients reported 9 symptoms (diarrhoea, nausea/vomiting, fever/febrile neutropenia, fatigue, pain, cutaneous and mucosal toxicities, hypertension, anxiety/depression) through the ZEMY application, which provided self-management recommendations and sent message alerts to healthcare professionals. To reach the primary feasibility endpoint, more than 50% of patients with one-sided 95% confidence interval (exact CI computed using Clopper-Pearson method) had to complete at least 3 symptoms entries, of which more than 60% complete until receiving a recommendation.ResultsOut of the 56 screened patients, 54 were included in the analysis between June 12th 2018 and January 11th 2019, and 52 completed the study. Over half of patients (31/54 [57.4%]) were feasibility responders, but this percentage was not significantly higher than the predefined minimum feasibility cut-off of 50%, as the lower limit of the one-sided 95% exact CI was 45.3%. Nonetheless, 87.0% of patients reported at least 3 symptoms with ZEMY and 66.0% had an entry completion rate ≥ 60%. Six of the 9 symptoms were reported at least once by more than 30% of the patients. The recommendations were considered relevant at least once for more than 80% of cases for each symptom. Patients were more satisfied (mean 10-point visual analogue scale score: 6.3 ± 2.9) with ZEMY than healthcare professionals (4.4 ± 1.5). The global patients’ quality of life remained stable during the study.ConclusionsZEMY provided satisfactory recommendations for the self-management of selected symptoms occurring during anti-cancer treatment and demonstrated good usability, but its feasibility was indemonstrable.Trail registrationThe trial was registered on June 14th 2018 at ClinicalTrails.gov (Trial Registration Number: NCT03558490).
Published Version
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