eRAPID RCT in systemic cancer treatment
Research type
Research Study
Full title
eRAPID Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: Randomised controlled trial in systemic cancer treatment
IRAS ID
156795
Contact name
Galina Velikova
Contact email
Clinicaltrials.gov Identifier
14/YH/1066, NRES Committee Yorkshire & The Humber - Leeds East
Research summary
Background
eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to self-report symptoms and side effects (known as adverse events or AE) during and after cancer treatments. eRAPID allows AE reporting from home or hospital and the patient reported data is integrated into existing Electronic Patient Records to allow for the reports to be used in routine care. In addition the system is capable of generating alerts for severe AE to the relevant clinical team and providing patient advice on managing mild AE.The overall aims of the eRAPID system are to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets.
Aims and Objectives
In the current study we plan to evaluate the eRAPID system from the perspective of both patients and staff. We will examine acceptability and adherence to the intervention with cancer patients receiving systemic treatment (chemotherapy/targeted agents) and explore any impact of the intervention on patient care and quality of life.Study sample and research design
Adult patients attending St James’ University Hospital Bexley Wing with early breast or colorectal cancer requiring adjuvant systemic treatment, or gynaecological cancer requiring chemotherapy will be eligible to take part in this study.
This will be a prospective randomised parallel group design study with repeated measures and mixed methods and will include an internal pilot phase. Participants will be randomised (following a 1:1 randomisation strategy) to receive the eRAPID intervention or usual care. We aim to recruit 568 patients to the study.Participants in the intervention arm will receive training in using the eRAPID system to report their symptoms and side effects (at least on a weekly basis) from home via the internet whilst they are receiving treatment. Hospital staff will be able to review eRAPID reports and use the information in the decision-making process when seeing patients in clinic or answering phone calls. Alerts will also be sent to the relevant clinical team when severe symptoms are reported by patients.
Study measures
This study will use several outcomes to compare the eRAPID intervention with standard care:Clinical outcomes and process of care measures (e.g. number of hospital contacts including admissions, clinic appointments, phone calls with hospital staff and changes to supportive medications and chemotherapy dose change).
Patient-reported outcomes
We will assess overall quality of life using validated questionnaires and appropriate subscales (e.g. FACT-G, EORTC-QLQ-C30 Role and Social function scales EQ-5D)We will also assess participants’ views of managing their health with measures of self-efficacy and patient activation.
Costs to patients and the NHS
Resource use will be assessed using patient questionnaires detailing contacts with GPs/community services, hospital visits and patient incurred costs. In addition participant records from PPM will be linked to costs held within the local pilot database of the National Patient-Level Information and Costing System (PLICS) scheme. This provides a cost for hospital based accident and emergency department visits, outpatient attendances and inpatient stays.Patient and staff interviews
Semi-structured staff, patients and carer interviews will be conducted to explore experiences of using the eRAPID intervention and any recommendations for improvement.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1066
Date of REC Opinion
10 Sep 2014
REC opinion
Further Information Favourable Opinion