Electronic self-reporting of adverse events for patients undergoing cancer treatment: the eRAPID research programme including two RCTs

Galina Velikova*, Kate Absolom, Jenny Hewison, Patricia Holch, Lorraine Warrington, Kerry Avery, Hollie Richards, Jane Blazeby, Bryony Dawkins, Claire Hulme, Robert Carter, Liz Glidewell, Ann Henry, Kevin Franks, Geoff Hall, Susan Davidson, Karen Henry, Carolyn Morris, Mark Conner, Lucy McParlandKatrina Walker, Eleanor Hudson, Julia Brown

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

4 Citations (Scopus)
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Abstract

Background
Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) and is frequently associated with adverse events that affect treatment delivery and quality of life. Regular adverse event reporting could improve care and safety through timely detection and management. Information technology provides a feasible monitoring model, but applied research is needed. This research programme developed and evaluated an electronic system, called eRAPID, for cancer patients to remotely self-report adverse events.

Objectives
The objectives were to address the following research questions: is it feasible to collect adverse event data from patients’ homes and in clinics during cancer treatment? Can eRAPID be implemented in different hospitals and treatment settings? Will oncology health-care professionals review eRAPID reports for decision-making? When added to usual care, will the eRAPID intervention (i.e. self-reporting with tailored advice) lead to clinical benefits (e.g. better adverse event control, improved patient safety and experiences)? Will eRAPID be cost-effective?

Design
Five mixed-methods work packages were conducted, incorporating co-design with patients and health-care professionals: work package 1 – development and implementation of the electronic platform across hospital centres; work package 2 – development of patient-reported adverse event items and advice (systematic and scoping reviews, patient interviews, Delphi exercise); work package 3 – mapping health-care professionals and care pathways; work package 4 – feasibility pilot studies to assess patient and clinician acceptability; and work package 5 – a single-centre randomised controlled trial of systemic treatment with a full health economic assessment.

Setting
The setting was three UK cancer centres (in Leeds, Manchester and Bristol).

Participants
The intervention was developed and evaluated with patients and clinicians. The systemic randomised controlled trial included 508 participants who were starting treatment for breast, colorectal or gynaecological cancer and 55 health-care professionals. The radiotherapy feasibility pilot recruited 167 patients undergoing treatment for pelvic cancers. The surgical feasibility pilot included 40 gastrointestinal cancer patients.

Intervention
eRAPID is an online system that allows patients to complete adverse event/symptom reports from home or hospital. The system provides immediate severity-graded advice based on clinical algorithms to guide self-management or hospital contact. Adverse event data are transferred to electronic patient records for review by clinical teams. Patients complete an online symptom report every week and whenever they experience symptoms.

Main outcome measures
In systemic treatment, the primary outcome was Functional Assessment of Cancer Therapy – General, Physical Well-Being score assessed at 6, 12 and 18 weeks (primary end point). Secondary outcomes included cost-effectiveness assessed through the comparison of health-care costs and quality-adjusted life-years. Patient self-efficacy was measured (using the Self-Efficacy for Managing Chronic Diseases 6-item Scale). The radiotherapy pilot studied feasibility (recruitment and attrition rates) and selection of outcome measures. The surgical pilot examined symptom report completeness, system actions, barriers to using eRAPID and technical performance.

Results
eRAPID was successfully developed and introduced across the treatments and centres. The systemic randomised controlled trial found no statistically significant effect of eRAPID on the primary end point at 18 weeks. There was a significant effect at 6 weeks (adjusted difference least square means 1.08, 95% confidence interval 0.12 to 2.05; p = 0.028) and 12 weeks (adjusted difference least square means 1.01, 95% confidence interval 0.05 to 1.98; p = 0.0395). No between-arm differences were found for admissions or calls/visits to acute oncology or chemotherapy delivery. Health economic analyses over 18 weeks indicated no statistically significant difference between the cost of the eRAPID information technology system and the cost of usual care (£12.28, 95% confidence interval –£1240.91 to £1167.69; p > 0.05). Mean differences were small, with eRAPID having a 55% probability of being cost-effective at the National Institute for Health and Care Excellence-recommended cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained. Patient self-efficacy was greater in the intervention arm (0.48, 95% confidence interval 0.13 to 0.83; p = 0.0073). Qualitative interviews indicated that many participants found eRAPID useful for support and guidance. Patient adherence to adverse-event symptom reporting was good (median compliance 72.2%). In the radiotherapy pilot, high levels of consent (73.2%) and low attrition rates (10%) were observed. Patient quality-of-life outcomes indicated a potential intervention benefit in chemoradiotherapy arms. In the surgical pilot, 40 out of 91 approached patients (44%) consented. Symptom report completion rates were high. Across the studies, clinician intervention engagement was varied. Both patient and staff feedback on the value of eRAPID was positive.

Limitations
The randomised controlled trial methodology led to small numbers of patients simultaneously using the intervention, thus reducing overall clinician exposure to and engagement with eRAPID. Furthermore, staff saw patients across both arms, introducing a contamination bias and potentially reducing the intervention effect. The health economic results were limited by numbers of missing data (e.g. for use of resources and EuroQol-5 Dimensions).

Conclusions
This research provides evidence that online symptom monitoring with inbuilt patient advice is acceptable to patients and clinical teams. Evidence of patient benefit was found, particularly during the early phases of treatment and in relation to self-efficacy. The findings will help improve the intervention and guide future trial designs.

Future work
Definitive trials in radiotherapy and surgical settings are suggested. Future research during systemic treatments could study self-report online interventions to replace elements of traditional follow-up care in the curative setting. Further research during modern targeted treatments (e.g. immunotherapy and small-molecule oral therapy) and in metastatic disease is recommended.

Trial registration
The systemic randomised controlled trial is registered as ISRCTN88520246. The radiotherapy trial is registered as ClinicalTrials.gov NCT02747264.
Original languageEnglish
Pages (from-to)i-xxx, 1-109
Number of pages145
JournalProgramme Grants for Applied Research
Volume10
Issue number1
DOIs
Publication statusPublished - 1 Feb 2022

Bibliographical note

Funding Information:
This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, NETSCC, PGfAR or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PGfAR programme or the Department of Health and Social Care.

Funding Information:
Declared competing interests of authors: Galina Velikova reports personal fees from Roche Holding AG (Basel, Switzerland), Eisai Co., Ltd (Tokyo, Japan) and Novartis International AG (Basel, Switzerland), grants from Breast Cancer Now (London, UK) and the European Organisation for Research and Treatment of Cancer (Brussels, Belgium), and personal fees from Pfizer Inc. (New York, NY, USA) outside the submitted work. Jane Blazeby reports being a member of the National Institute for Health Research (NIHR) Clinical Trials Unit Standing Advisory Group (2015–19), the NIHR Health Technology Assessment (HTA) Surgery Themed Call Board (2012–13), the NIHR HTA Commissioning Board for Obesity (2011–12) and the NIHR HTA Strategy Committee (2009–12). Julia Brown reports being a member of the NIHR HTA Clinical Evaluation and Trials Funding Committee (2017 to present). Claire Hulme reports being a member of the NIHR HTA Commissioning Board (2013–17). Ann Henry reports grants from the NIHR Research for Patient Benefit programme (PB-PG-0816-10017: effective clinical cancer treatment, care and management of people with co-morbid cancer and dementia), Medical Research Council, Cancer Research UK (London, UK) and Royal College of Radiologists outside the submitted work. Kevin Franks reports personal fees and non-financial support from AstraZeneca plc (Cambridge, UK), personal fees from Roche Holding AG, Bristol Myers Squibb™ (New York, NY, USA) and Pfizer Inc., and non-financial support from Boerhinger Ingleheim (Ingelheim am Rhein, Germany) and Takeda Pharmaceutical Company Limited (Tokyo, Japan) outside the submitted work.

Publisher Copyright:
© 2022 Velikova et al.

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