Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART)—Maguire 2021

OBJECTIVE: To examine the impact of remote monitoring of adjuvant chemotherapy side effects via Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care demands, anxiety, self-efficacy, and work constraints. Design: Multicenter, repeated measurements, parallel group, masked evaluator, stratified RCT. Setting:12 cancer centers in Austria, Greece, Norway, Ireland, and UK. Participants: 829 people with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma. Intervention: Over six cycles of chemotherapy, patients were randomly assigned ASyMS (n=415) or conventional treatment (n=414). MAIN RESULTS: MSAS measured symptom load. Secondary outcomes included quality of life (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 job limits questionnaire (WLQ). For the intervention group, symptom burden stayed at pre-chemotherapy levels, but controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains showed substantial reductions in favor of ASyMS for global distress index (-0.21, -0.27 to -0.16; P0.001), psychological symptoms (-0.16, -0.23 to -0.10; P0.001), and physical symptoms (-0.21, -0.26 to -0.17; P0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% CI 2.65 to 5.46; P0.001), but STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and state anxiety (-1.13, -2.06 to -0.20; P=0.02) scores were lower. Most SCNS-SF34 domains were lower in the intervention group, including sexuality requirements (-1.56, -3.11 to -0.01; P0.05), 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). WLQ and other SCNS-SF34 domains weren't different. ASyMS is safe. Intervention caused more neutropenia. Significant symptom decrease validates ASyMS for remote cancer symptom monitoring. Cohen's effect size of 0.5 revealed ASyMS's positive therapeutic effect on patients' symptoms. Future services will need remote monitoring systems, especially with covid-19-inspired blended care models.

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. https://doi.org/10.1136/bmj.n1647