TY - JOUR

T1 - Digital Remote Monitoring Using an mHealth Solution for Survivors of Cancer: Protocol for a Pilot Observational Study

AU - Innominato, Pasquale F

AU - Macdonald, Jamie

AU - Saxton, Wendy

AU - Longshaw, Laura

AU - Granger, Rachel

AU - Naja, Iman

AU - Allocca, Carlo

AU - Edwards, Ruth

AU - Rasheed, Solan

AU - Folkvord, Frans

AU - de Battle, Jordi

AU - Ail, Rohit

AU - Motta, Enrico

AU - Bale, Catherine

AU - Fuller, Claire

AU - Mullard, Anna P.

AU - Subbe, Chris

AU - Griffiths, Dawn

AU - Wreglesworth, Nicholas

AU - Pecchia, Leandro

AU - Fico, Giuseppe

AU - Antonini, Alessio

N1 - ©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.

PY - 2024/4/30

Y1 - 2024/4/30

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Cancer Survivors

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Mobile Applications

KW - Neoplasms/therapy

KW - Observational Studies as Topic/methods

KW - Pilot Projects

KW - Telemedicine/methods

KW - Wales

U2 - 10.2196/52957

DO - 10.2196/52957

M3 - Article

C2 - 38687985

VL - 13

SP - e52957

JO - JMIR Research Protocols

JF - JMIR Research Protocols

SN - 1929-0748

M1 - e52957

ER -