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

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

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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.

Original languageEnglish
Article numbern1647
Number of pages14
JournalBMJ
Volume374
DOIs
Publication statusPublished - 22 Jul 2021

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