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

Roma Maguire, Lisa McCann, Grigorios Kotronoulas, Nora Kearney, Emma Ream, Jo Armes, Elisabeth Patiraki, Eileen Furlong, Patricia Fox, Alexander Gaiger, Paul McCrone, Geir Berg, Christine Miaskowski, Antonella Cardone, Dawn Orr, Adrian Flowerday, Stylianos Katsaragakis, Andrew Darley, Simone Lubowitzki, Jenny Harris, Simon Skene, Morven Miller, Margaret Moore, Liane Lewis, Nicosha DeSouza, Peter T Donnan, Roma Maguire, Lisa McCann, Grigorios Kotronoulas, Nora Kearney, Emma Ream, Jo Armes, Elisabeth Patiraki, Eileen Furlong, Patricia Fox, Alexander Gaiger, Paul McCrone, Geir Berg, Christine Miaskowski, Antonella Cardone, Dawn Orr, Adrian Flowerday, Stylianos Katsaragakis, Andrew Darley, Simone Lubowitzki, Jenny Harris, Simon Skene, Morven Miller, Margaret Moore, Liane Lewis, Nicosha DeSouza, Peter T Donnan

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.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: financial support from the European Commission for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Fig 1
Fig 1
Advanced Symptom Management System (ASyMS) intervention. DCTAQ=Daily Chemotherapy Toxicity Self-Assessment Questionnaire
Fig 2
Fig 2
Overview of example symptom management protocol (nausea and vomiting) on Advanced Symptom Management System (ASyMS). DCTAQ=Daily Chemotherapy Toxicity Self-Assessment Questionnaire; HCP=healthcare professional
Fig 3
Fig 3
CONSORT diagram for eSMART. *Some people reported more than one reason for not wanting to take part, so total number of reasons exceeds number declined/excluded

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