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
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Maguire, Roma, Fox, PA, McCann, Lisa, Miaskowski, C, Kotronoulas, G, Miller, M, Furlong, E, Ream, Emma, Armes, J, Patiraki, E, Gaiger, A, Berg, GV, Flowerday, A, Donnan, P, McCrone, P, Apostolidis, K, Harris, J, Katsaragakis, S, Buick, AR and 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, 7 (5), e015016.
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CLEAN_REVISED_eSMART Protocol for publication Final Manuscript February 7th 2017.docx - Accepted version Manuscript Restricted to Repository staff only Available under License : See the attached licence file. Download (71kB) |
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 eSMART study (electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology) is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised, controlled trial (RCT) of oncology patients. Methods and analysis A total of 1,108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal, or haematological cancer will be recruited from multiple sites across 5 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 (ePROMS) at enrolment, after each of their CTX cycles (up to a maximum of 6 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 (QoL), 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 eSMART received approval from the relevant ethics committees at all of the clinical sites across the 5 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.
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| Subjects : | Health Sciences | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Divisions : | Faculty of Health and Medical Sciences > School of Health Sciences | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Date : | 1 May 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Identification Number : | https://doi.org/10.1136/bmjopen-2016-015016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Copyright Disclaimer : | This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. © 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Uncontrolled Keywords : | cancer, chemotherapy, information technology, symptom management, randomised controlled trial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Depositing User : | Symplectic Elements | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date Deposited : | 24 Mar 2017 10:07 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Last Modified : | 04 Jul 2017 17:16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| URI: | http://epubs.surrey.ac.uk/id/eprint/813847 |
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