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Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART)
Open accessAbstract
Objective: To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations. Design: Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial. Setting: Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK. Participants: 829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin’s disease, or non-Hodgkin’s lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years. Intervention: Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy. Main outcome measures: The primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy—General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory—Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ). Results: For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference −0.15, 95% confidence interval −0.19 to −0.12; P<0.001; Cohen’s D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (−0.21, −0.27 to −0.16; P<0.001), psychological symptoms (−0.16, −0.23 to −0.10; P<0.001), and physical symptoms (−0.21, −0.26 to −0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (−1.15, −1.90 to −0.41; P=0.003) and STAI-R state anxiety (−1.13, −2.06 to −0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (−1.56, −3.11 to −0.01; P<0.05), patient care and support needs (−1.74, −3.31 to −0.16; P=0.03), and physical and daily living needs (−2.8, −5.0 to −0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group. Conclusions: Significant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A “medium” Cohen’s effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients’ symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic. Trial registration: Clinicaltrials.gov NCT02356081 .
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“However, several randomized clinical trials with similar interventions have proven that RPM significantly improves symptom burden in comparison with routine care.7,13,14”
From Implementation of a remote symptom monitoring pathway in oncology care: analysis of real-world experience across 33 cancer centres in France and Belgium (2024) · cites this paper as [14]
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Metadata
- Authors
- Maguire, R., McCann, L., Kotronoulas, G., Kearney, N., Ream, E., Armes, J., Patiraki, E., Furlong, E., Fox, P., Gaiger, A., McCrone, P., Berg, G., Miaskowski, C., Cardone, A., Orr, D., Flowerday, A., Katsaragakis, S., Darley, A., Lubowitzki, S., Harris, J., Skene, S., Miller, M., Moore, M., Lewis, L., DeSouza, N., & Donnan, P. T.
- Affiliations
- University of Strathclyde (GB)
- University of Glasgow (GB)
- University of Surrey (GB)
- National and Kapodistrian University of Athens (GR)
- University College Dublin (IE)
- Medical University of Vienna (AT)
- King's College London (GB)
- Norwegian University of Science and Technology (NO)
- University of California, San Francisco (US)
- Docobo (United Kingdom) (GB)
- Johnson & Johnson (Germany) (DE)
- University of Dundee (GB)
- Corresponding author
- Maguire, Roma
- ORCID
- Maguire, Roma
- McCann, Lisa
- Kotronoulas, Grigorios
- Kearney, Nora
- Ream, Emma
- Armes, Jo
- Patiraki, Elisabeth
- Furlong, Eileen
- Fox, Patricia
- Gaiger, Alexander
- McCrone, Paul
- Berg, Geir
- Miaskowski, Christine
- Orr, Dawn
- Flowerday, Adrian
- Katsaragakis, Stylianos
- Darley, Andrew
- Lubowitzki, Simone
- Harris, Jenny
- Skene, Simon
- Miller, Morven
- Moore, Margaret
- Lewis, Liane
- Donnan, Peter T
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2021-07-21
- Volume
- 374
- Pages
- n1647
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC8293749
- OpenAlex
- W3183953444
- Cited by
- 243
- References
- 57
- Citations by year
- 2026: 40 · 2025: 58 · 2024: 62 · 2023: 48 · 2022: 31 · 2021: 4
- FWCI
- 13.21
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- BMJ (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- Strathprints: The University of Strathclyde institutional repository (University of Strathclyde) (acceptedVersion, cc-by)
- Discovery Research Portal (University of Dundee) (submittedVersion, cc-by)
- Research Portal (King's College London) (submittedVersion, cc-by)
- Funders
- University College London
- European Commission
- Sykehuset Innlandet HF
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- remote symptom monitoring, adjuvant chemotherapy, cancer symptoms, symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, work limitations, non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, non-Hodgkin lymphoma, real-time patient monitoring
- MeSH terms
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Austria, Breast Neoplasms, Female, United Kingdom, Greece, Hodgkin Disease, Humans, Ireland, Lymphoma, Non-Hodgkin, Male, Middle Aged, Norway, Quality of Life, Colorectal Neoplasms, Treatment Outcome, Chemotherapy, Adjuvant, Telemedicine, Cell Phone, Drug-Related Side Effects and Adverse Reactions
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