Digital Remote Monitoring Using an mHealth Solution for Survivors of Cancer: Protocol for a Pilot Observational Study.

Autor:	Innominato PF; Oncology Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom.; Warwick Medical School & Cancer Research Centre, University of Warwick, Coventry, United Kingdom.; Chronotherapy, Cancers and Transplantation Research Unit, Faculty of Medicine, Université Paris-Saclay, Villejuif, France., Macdonald JH; Institute for Applied Human Physiology, School of Psychology and Sports Science, Bangor University, Bangor, United Kingdom., Saxton W; Research and Development Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Longshaw L; Research and Development Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Granger R; Institute for Applied Human Physiology, School of Psychology and Sports Science, Bangor University, Bangor, United Kingdom., Naja I; Knowledge Media Institute, The Open University, Milton Keynes, United Kingdom., Allocca C; Health Innovation, Samsung, Staines, United Kingdom., Edwards R; Dietetics Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Rasheed S; Dietetics Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Folkvord F; PredictBy, Barcelona, Spain.; Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands., de Batlle J; Institut de Recerca Biomèdica de Lleida, Lleida, Spain., Ail R; Health Innovation, Samsung, Staines, United Kingdom., Motta E; Knowledge Media Institute, The Open University, Milton Keynes, United Kingdom., Bale C; Oncology Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Fuller C; Oncology Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Mullard AP; Oncology Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Subbe CP; Acute and Critical Care Medicine, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom.; School of Medical Sciences, Bangor University, Bangor, United Kingdom., Griffiths D; Oncology Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom., Wreglesworth NI; Oncology Department, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom.; School of Medical Sciences, Bangor University, Bangor, United Kingdom., Pecchia L; School of Engineering, University of Warwick, Coventry, United Kingdom.; Facoltà Dipartimentale di Ingegneria, Università Campus Bio-Medico di Roma, Rome, Italy., Fico G; Life Supporting Technologies, Escuela Técnica Superior de Ingenieros de Telecomunicaciones, Universidad Politécnica de Madrid, Madrid, Spain., Antonini A; Knowledge Media Institute, The Open University, Milton Keynes, United Kingdom.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2024 Apr 30; Vol. 13, pp. e52957. Date of Electronic Publication: 2024 Apr 30.
DOI:	10.2196/52957
Abstrakt:	Background: Healthy lifestyle interventions have a positive impact on multiple disease trajectories, including cancer-related outcomes. Specifically, appropriate habitual physical activity, adequate sleep, and a regular wholesome diet are of paramount importance for the wellness and supportive care of survivors of cancer. Mobile health (mHealth) apps have the potential to support novel tailored lifestyle interventions. Objective: This observational pilot study aims to assess the feasibility of mHealth multidimensional longitudinal monitoring in survivors of cancer. The primary objective is to test the compliance (user engagement) with the monitoring solution. Secondary objectives include recording clinically relevant subjective and objective measures collected through the digital solution. Methods: This is a monocentric pilot study taking place in Bangor, Wales, United Kingdom. We plan to enroll up to 100 adult survivors of cancer not receiving toxic anticancer treatment, who will provide self-reported behavioral data recorded via a dedicated app and validated questionnaires and objective data automatically collected by a paired smartwatch over 16 weeks. The participants will continue with their normal routine surveillance care for their cancer. The primary end point is feasibility (eg, mHealth monitoring acceptability). Composite secondary end points include clinically relevant patient-reported outcome measures (eg, the Edmonton Symptom Assessment System score) and objective physiological measures (eg, step counts). This trial received a favorable ethical review in May 2023 (Integrated Research Application System 301068). Results: This study is part of an array of pilots within a European Union funded project, entitled "GATEKEEPER," conducted at different sites across Europe and covering various chronic diseases. Study accrual is anticipated to commence in January 2024 and continue until June 2024. It is hypothesized that mHealth monitoring will be feasible in survivors of cancer; specifically, at least 50% (50/100) of the participants will engage with the app at least once a week in 8 of the 16 study weeks. Conclusions: In a population with potentially complex clinical needs, this pilot study will test the feasibility of multidimensional remote monitoring of patient-reported outcomes and physiological parameters. Satisfactory compliance with the use of the app and smartwatch, whether confirmed or infirmed through this study, will be propaedeutic to the development of innovative mHealth interventions in survivors of cancer. International Registered Report Identifier (irrid): PRR1-10.2196/52957. (©Pasquale F Innominato, Jamie H Macdonald, Wendy Saxton, Laura Longshaw, Rachel Granger, Iman Naja, Carlo Allocca, Ruth Edwards, Solah Rasheed, Frans Folkvord, Jordi de Batlle, Rohit Ail, Enrico Motta, Catherine Bale, Claire Fuller, Anna P Mullard, Christian P Subbe, Dawn Griffiths, Nicholas I Wreglesworth, Leandro Pecchia, Giuseppe Fico, Alessio Antonini. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.04.2024.)
Databáze:	MEDLINE
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