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Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART).
Maguire, Roma; McCann, Lisa; Kotronoulas, Grigorios; Kearney, Nora; Ream, Emma; Armes, Jo; Patiraki, Elisabeth; Furlong, Eileen; Fox, Patricia; Gaiger, Alexander; McCrone, Paul; Berg, Geir; Miaskowski, Christine; Cardone, Antonella; Orr, Dawn; Flowerday, Adrian; Katsaragakis, Stylianos; Darley, Andrew; Lubowitzki, Simone; Harris, Jenny; Skene, Simon; Miller, Morven; Moore, Margaret; Lewis, Liane; DeSouza, Nicosha; Donnan, Peter T.
  • Maguire R; Computer and Information Sciences, University of Strathclyde, Glasgow, UK Roma.maguire@strath.ac.uk.
  • McCann L; Computer and Information Sciences, University of Strathclyde, Glasgow, UK.
  • Kotronoulas G; School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.
  • Kearney N; Leven, UK.
  • Ream E; University of Surrey, School of Health Sciences, Guildford, UK.
  • Armes J; University of Surrey, School of Health Sciences, Guildford, UK.
  • Patiraki E; National and Kapodistrian University of Athens School of Health Sciences, Athens, Greece.
  • Furlong E; School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland.
  • Fox P; School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland.
  • Gaiger A; Department of Internal Medicine 1, Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.
  • McCrone P; Department of Health Services and Population Research, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
  • Berg G; Department of Health Sciences, NTNU, Gjøvik, Norway.
  • Miaskowski C; University of California San Francisco, San Francisco, CA, USA.
  • Cardone A; European Cancer Patient Coalition, Brussels, Belgium.
  • Orr D; NHS 24, Glasgow, UK.
  • Flowerday A; Docobo Limited, Leatherhead, UK.
  • Katsaragakis S; National and Kapodistrian University of Athens School of Health Sciences, Athens, Greece.
  • Darley A; School of Medicine, University College Dublin, Dublin, Ireland.
  • Lubowitzki S; Department of Internal Medicine 1, Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.
  • Harris J; University of Surrey, School of Health Sciences, Guildford, UK.
  • Skene S; Surrey Clinical Trials Unit, University of Surrey, Guildford, UK.
  • Miller M; Computer and Information Sciences, University of Strathclyde, Glasgow, UK.
  • Moore M; Computer and Information Sciences, University of Strathclyde, Glasgow, UK.
  • Lewis L; Johnson and Johnson Medical, Norderstedt, Germany.
  • DeSouza N; Population Health and Genomics, Medical School, University of Dundee, Dundee, UK.
  • Donnan PT; Population Health and Genomics, Medical School, University of Dundee, Dundee, UK.
BMJ ; 374: n1647, 2021 07 21.
Article in English | MEDLINE | ID: covidwho-1320441
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Quality of Life / Antineoplastic Combined Chemotherapy Protocols / Telemedicine / Cell Phone / Drug-Related Side Effects and Adverse Reactions Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Journal: BMJ Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: Bmj.n1647

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Quality of Life / Antineoplastic Combined Chemotherapy Protocols / Telemedicine / Cell Phone / Drug-Related Side Effects and Adverse Reactions Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Journal: BMJ Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: Bmj.n1647