The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer

Roma Maguire, Patricia A Fox, Lisa McCann, Christine Miaskowski, Grigorios Kotronoulas, Morven Miller, Eileen Furlong, Emma Ream, Jo Armes, Elisabeth Patiraki, Alexander Gaiger, Geir V Berg, Adrian Flowerday, Peter Donnan, Paul McCrone, Kathi Apostolidis, Jenny Harris, Stylianos Katsaragakis, Alison R Buick, Nora Kearney

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients.

Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes).

Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts.

Trial registration number NCT02356081.

LanguageEnglish
Article numbere015016
Number of pages10
JournalBMJ Open
Volume7
Issue number5
DOIs
Publication statusPublished - 1 May 2017

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Randomized Controlled Trials
Technology
Neoplasms
Ethics Committees
Control Groups
Self Efficacy
Self Care
Ethics
Publications
Breast
Anxiety
Quality of Life
Demography
Delivery of Health Care
Drug Therapy
Equipment and Supplies
Health

Keywords

  • cancer
  • chemotherapy
  • information technology
  • randomised controlled trial
  • symptom management

Cite this

Maguire, Roma ; Fox, Patricia A ; McCann, Lisa ; Miaskowski, Christine ; Kotronoulas, Grigorios ; Miller, Morven ; Furlong, Eileen ; Ream, Emma ; Armes, Jo ; Patiraki, Elisabeth ; Gaiger, Alexander ; Berg, Geir V ; Flowerday, Adrian ; Donnan, Peter ; McCrone, Paul ; Apostolidis, Kathi ; Harris, Jenny ; Katsaragakis, Stylianos ; Buick, Alison R ; Kearney, Nora. / The eSMART study protocol : a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. In: BMJ Open. 2017 ; Vol. 7, No. 5.
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Maguire, R, Fox, PA, McCann, L, Miaskowski, C, Kotronoulas, G, Miller, M, Furlong, E, Ream, E, Armes, J, Patiraki, E, Gaiger, A, Berg, GV, Flowerday, A, Donnan, P, McCrone, P, Apostolidis, K, Harris, J, Katsaragakis, S, Buick, AR & Kearney, N 2017, 'The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer' BMJ Open, vol. 7, no. 5, e015016. https://doi.org/10.1136/bmjopen-2016-015016

The eSMART study protocol : a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. / Maguire, Roma; Fox, Patricia A; McCann, Lisa; Miaskowski, Christine; Kotronoulas, Grigorios; Miller, Morven; Furlong, Eileen; Ream, Emma; Armes, Jo; Patiraki, Elisabeth; Gaiger, Alexander; Berg, Geir V; Flowerday, Adrian; Donnan, Peter; McCrone, Paul; Apostolidis, Kathi; Harris, Jenny; Katsaragakis, Stylianos; Buick, Alison R; Kearney, Nora.

In: BMJ Open, Vol. 7, No. 5, e015016, 01.05.2017.

Research output: Contribution to journalArticle

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T1 - The eSMART study protocol

T2 - BMJ Open

AU - Maguire, Roma

AU - Fox, Patricia A

AU - McCann, Lisa

AU - Miaskowski, Christine

AU - Kotronoulas, Grigorios

AU - Miller, Morven

AU - Furlong, Eileen

AU - Ream, Emma

AU - Armes, Jo

AU - Patiraki, Elisabeth

AU - Gaiger, Alexander

AU - Berg, Geir V

AU - Flowerday, Adrian

AU - Donnan, Peter

AU - McCrone, Paul

AU - Apostolidis, Kathi

AU - Harris, Jenny

AU - Katsaragakis, Stylianos

AU - Buick, Alison R

AU - Kearney, Nora

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. Trial registration number NCT02356081.

AB - Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. Trial registration number NCT02356081.

KW - cancer

KW - chemotherapy

KW - information technology

KW - randomised controlled trial

KW - symptom management

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