Cited by 244Cancer survivorship and careTelemedicine and Telehealth ImplementationMobile Health and mHealth Applications

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART)

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Maguire, Roma, McCann, Lisa, Kotronoulas, Grigorios, Kearney, Nora, Ream, Emma, Armes, Jo, Patiraki, Elisabeth, Furlong, Eileen +18 more·2021·BMJ

Abstract

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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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
Venue
BMJ
Publisher
BMJ
Published
2021-07-21
Volume
374
Pages
n1647
ISSN
1756-1833 (ISSN-L)
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
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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