Health Services and Outcomes
DOI: 10.1200/JCO.20.02015 Journal of Clinical Oncology - published online before print January 8, 2021
Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy
2Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom
3Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom
4Patient Representative, Independent Cancer Patients Voices, Brighton, United Kingdom
5Psychology Group, School of Social Sciences, Faculty of Health and Social Sciences, Leeds Beckett University, Leeds, United Kingdom
6Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, St James's University Hospital, Leeds, United Kingdom
7School of Psychology, University of Leeds, Leeds, United Kingdom
8Patient Representative, Research Advisory Group to Patient-Centred Outcomes Research at Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom
9University of Exeter, St Luke's Campus, Exeter, United Kingdom
*J.B. and G.V. are joint senior authors.
Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent.
Patients with colorectal, breast, or gynecological cancers commencing chemotherapy were randomly assigned to usual care (UC) or the addition of eRAPID (weekly online symptom reporting for 18 weeks). Primary outcome was symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB]) assessed at 6, 12, and 18 weeks. Secondary outcomes were processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy–General, EQ5D-VAS, and EORTC QLQ-C30 summary score). Multivariable mixed-effects repeated-measures models were used for analyses. Trial registration: ISRCTN88520246.
Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals. eRAPID compared to UC showed improved physical well-being at 6 (P = .028) and 12 (P = .039) weeks and no difference at 18 weeks (primary end point) (P = .69). Fewer eRAPID patients (47%) had clinically meaningful physical well-being deterioration than UC (56%) at 12 weeks. Subgroup analysis found benefit in the nonmetastatic group at 6 weeks (P = .0426), but not in metastatic disease. There were no differences for admissions or chemotherapy delivery. At 18 weeks, patients using eRAPID reported better self-efficacy (P = .007) and better health on EQ5D-VAS (P = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician's data use and improved FACT-PWB at 12 weeks.
Can we control better treatment- and disease-related symptoms during chemotherapy by introducing online monitoring with patient-reported outcome measures, uniquely combined with automated algorithm-driven severity-dependent patient advice?
In a patient population treated predominantly with curative intent, online monitoring plus immediate patient advice improved physical well-being early during the chemotherapy (6 and 12 weeks), without increasing healthcare utilization. Patients reported better self-efficacy and confidence in self-managing their symptoms.
These findings extend the evidence of benefits from online symptom monitoring in advanced cancers to the curative treatment setting. This approach offers an alternative model of care delivery during curative chemotherapy, supporting patients with cancer experiencing mild to moderate symptoms and potentially reducing hospital visits. The COVID-19 pandemic has precipitated a shift to remote technology-enabled care. Online symptom monitoring is a feasible strategy to be implemented in routine cancer care.
Presented at the American Society for Clinical Oncology Annual Meeting 2020, Chicago, IL, May 30-June 2.
Supported by the National Institute for Health Research (NIHR), Research Program Grant for Applied Research (RP-PG-0611-20008). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Conception and design: Kate Absolom, Lorraine Warrington, Jenny Hewison, Carolyn Morris, Patricia Holch, Mark Conner, Barbara Woroncow, Claire Hulme, Julia Brown, Galina Velikova
Financial support: Galina Velikova
Provision of study materials or patients: Carolyn Morris, Liz Glidewell, Barbara Woroncow, Galina Velikova
Collection and assembly of data: Kate Absolom, Lorraine Warrington, Robert Carter, Andrea Gibson, Marie Holmes, Beverly Clayton, Zoe Rogers, Liz Glidewell, Sarah Dickinson, Claire Hulme, Julia Brown, Galina Velikova
Data analysis and interpretation: Kate Absolom, Lorraine Warrington, Eleanor Hudson, Jenny Hewison, Patricia Holch, Lucy McParland, Mark Conner, Liz Glidewell, Bryony Dawkins, Claire Hulme, Julia Brown, Galina Velikova
Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.
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Research Funding: Roche
Other Relationship: NIHR
Honoraria: Eisai, Novartis, Pfizer, Roche UK
Consulting or Advisory Role: Roche UK, Eisai, Novartis
Speakers' Bureau: Novartis
Research Funding: Pfizer
Travel, Accommodations, Expenses: Roche UK, Novartis, Eisai
Other Relationship: University of Leeds
No other potential conflicts of interest were reported.