Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 21, 2023
Date Accepted: Feb 5, 2024
Digital remote monitoring using a mobile health solution in cancer survivors: an observational pilot trial protocol
ABSTRACT
Background:
Healthy lifestyle habits have a positive impact on multiple diseases trajectories, including cancer-related outcomes. Specifically, appropriate habitual physical activity and regular wholesome diet are of paramount importance for the wellness and the supportive care of cancer survivors. Mobile health (mHealth) applications have the potential to support novel tailored lifestyle interventions.
Objective:
This observational pilot aims to assess the feasibility of mHealth multidimensional longitudinal monitoring in cancer survivors. The primary objective is to test the compliance with the user engagement with the monitoring solution over 16 weeks on-study.
Methods:
This is a monocentric pilot taking place in Bangor, Wales, UK. We plan to enrol up to 100 adult cancer survivors not receiving toxic anticancer treatment, who will provide self-reported behavioural data (on diet, physical activity and sleep), recorded via a dedicated app and validated questionnaires, and objective data (movement, heart rate, SpO2) automatically collected by a paired smart watch over 4 months. The participants will continue with their surveillance care for their cancer. The primary endpoint is feasibility, and composite secondary endpoints include clinically-relevant patient-reported outcome measures and objective physiological measures.
Results:
This study is part of an array of pilots within an EU-funded project entitled GATEKEEPER conducted at different sites across Europe and covering various chronic diseases. This trial has received favourable ethical review in May 2023 (IRAS 301068). Study accrual is anticipated to commence in October 2023 and continue until January 2024.
Conclusions:
This pilot will test in a population with potentially complex clinical needs the feasibility of multidimensional remote monitoring of patient-reported outcomes and of physiological parameters. Satisfactory compliance with the use of the app and the smartwatch, whether confirmed or infirmed through this study, will be propaedeutic to the development of innovative Artificial Intelligence-based bespoken interventions in cancer survivors. Clinical Trial: Pending
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Copyright
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