TY - JOUR
TI - 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,
AU - Nora
AU - Ream, Emma
AU - Armes, Jo
AU - Patiraki, Elisabeth
AU - Furlong,
AU - Eileen
AU - Fox, Patricia
AU - Gaiger, Alexander
AU - McCrone, Paul and
AU - Berg, Geir
AU - Miaskowkski, Christine
AU - Cardone, Antonella
AU - Orr,
AU - Dawn
AU - Flowerday, Adrian
AU - Katsaragakis, Stylianos
AU - Darley,
AU - Andrew
AU - Lubowitzki, Simone
AU - Harris, Jenny
AU - Skene, Simon and
AU - Miller, Morven
AU - Moore, Margaret
AU - Lewis, Liane
AU - DeSouza, Nicosha
AU - and Donnan, Peter T.
JO - BMJ (British Medical Journal)
PY - 2021
VL - 374
TODO - null
SP - null
PB - BMJ Publishing Group
SN - 0959-8138, 1756-1833
TODO - 10.1136/bmj.n1647
TODO - null
TODO - 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
nonHodgkin’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.
ER -