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Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART).
BMJ. 2021 07 21; 374:n1647.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.

Authors+Show Affiliations

Computer and Information Sciences, University of Strathclyde, Glasgow, UK Roma.maguire@strath.ac.uk.Computer and Information Sciences, University of Strathclyde, Glasgow, UK.School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.Leven, UK.University of Surrey, School of Health Sciences, Guildford, UK.University of Surrey, School of Health Sciences, Guildford, UK.National and Kapodistrian University of Athens School of Health Sciences, Athens, Greece.School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland.School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland.Department of Internal Medicine 1, Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.Department of Health Services and Population Research, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.Department of Health Sciences, NTNU, Gjøvik, Norway.University of California San Francisco, San Francisco, CA, USA.European Cancer Patient Coalition, Brussels, Belgium.NHS 24, Glasgow, UK.Docobo Limited, Leatherhead, UK.National and Kapodistrian University of Athens School of Health Sciences, Athens, Greece.School of Medicine, University College Dublin, Dublin, Ireland.Department of Internal Medicine 1, Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.University of Surrey, School of Health Sciences, Guildford, UK.Surrey Clinical Trials Unit, University of Surrey, Guildford, UK.Computer and Information Sciences, University of Strathclyde, Glasgow, UK.Computer and Information Sciences, University of Strathclyde, Glasgow, UK.Johnson and Johnson Medical, Norderstedt, Germany.Population Health and Genomics, Medical School, University of Dundee, Dundee, UK.Population Health and Genomics, Medical School, University of Dundee, Dundee, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34289996

Citation

Maguire, Roma, et al. "Real Time Remote Symptom Monitoring During Chemotherapy for Cancer: European Multicentre Randomised Controlled Trial (eSMART)." BMJ (Clinical Research Ed.), vol. 374, 2021, pp. n1647.
Maguire R, McCann L, Kotronoulas G, et al. Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). BMJ. 2021;374:n1647.
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., ... Donnan, P. T. (2021). Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). BMJ (Clinical Research Ed.), 374, n1647. https://doi.org/10.1136/bmj.n1647
Maguire R, et al. Real Time Remote Symptom Monitoring During Chemotherapy for Cancer: European Multicentre Randomised Controlled Trial (eSMART). BMJ. 2021 07 21;374:n1647. PubMed PMID: 34289996.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). AU - Maguire,Roma, AU - McCann,Lisa, AU - Kotronoulas,Grigorios, AU - Kearney,Nora, AU - Ream,Emma, AU - Armes,Jo, AU - Patiraki,Elisabeth, AU - Furlong,Eileen, AU - Fox,Patricia, AU - Gaiger,Alexander, AU - McCrone,Paul, AU - Berg,Geir, AU - Miaskowski,Christine, AU - Cardone,Antonella, AU - Orr,Dawn, AU - Flowerday,Adrian, AU - Katsaragakis,Stylianos, AU - Darley,Andrew, AU - Lubowitzki,Simone, AU - Harris,Jenny, AU - Skene,Simon, AU - Miller,Morven, AU - Moore,Margaret, AU - Lewis,Liane, AU - DeSouza,Nicosha, AU - Donnan,Peter T, Y1 - 2021/07/21/ PY - 2021/7/22/entrez PY - 2021/7/23/pubmed PY - 2021/7/28/medline SP - n1647 EP - n1647 JF - BMJ (Clinical research ed.) JO - BMJ VL - 374 N2 - 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. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/34289996/Real_time_remote_symptom_monitoring_during_chemotherapy_for_cancer:_European_multicentre_randomised_controlled_trial_(eSMART). L2 - http://www.bmj.com/lookup/pmidlookup?view=long&amp;pmid=34289996 DB - PRIME DP - Unbound Medicine ER -