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