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

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  • Pasquale F Innominato
    Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Bangor LL57 2PW, UK
  • Jamie Macdonald
  • Wendy Saxton
    Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Bangor LL57 2PW, UK
  • Laura Longshaw
    Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Bangor LL57 2PW, UK
  • Rachel Granger
  • Iman Naja
    Open University
  • Carlo Allocca
    Health Innovation
  • Ruth Edwards
    Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Bangor LL57 2PW, UK
  • Solan Rasheed
    Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Bangor LL57 2PW, UK
  • Frans Folkvord
    Tilburg University, Netherlands
  • Jordi de Battle
    Institut de Recerca Biomèdica de Lleida
  • Rohit Ail
    Health Innovation
  • Enrico Motta
    Open University
  • Catherine Bale
    Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Bangor LL57 2PW, UK
  • Claire Fuller
    Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Bangor LL57 2PW, UK
  • Anna P. Mullard
    Ysbyty Gwynedd
  • Chris Subbe
  • Dawn Griffiths
    Ysbyty Gwynedd
  • Nicholas Wreglesworth
  • Leandro Pecchia
    University of Warwick
  • Giuseppe Fico
    Universidad Politécnica de Madrid
  • Alessio Antonini
    Open University
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.
Iaith wreiddiolSaesneg
Rhif yr erthygle52957
CyfnodolynJMIR Research Protocols
Cyfrol13
Dynodwyr Gwrthrych Digidol (DOIs)
StatwsCyhoeddwyd - 30 Ebr 2024
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