ePRIME:Feasibility Study of Patient-Reported AEs in Early Phase Trials
Research type
Research Study
Full title
electronic Patient self-Reported outcomes to Improve cancer Management and patient Experiences (ePRIME): Collection of patient-reported adverse events in Early Phase Clinical Trials in Yorkshire
IRAS ID
237796
Contact name
Galina Velikova
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
NCT03461939, ClinicalTrials.gov
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Background: New treatments are continually being developed to help patients living with advanced cancer. Such treatments require extensive clinical trials before authorisation for standard clinical use. Reporting of adverse events (AE) in this setting is essential to ensure treatment safety and tolerability. The current system for reporting AEs, the National Cancer Institute Common Toxicity Criteria and Adverse Events (NCI CTCAE) relies on the clinician’s interpretation of patient symptoms. However, a substantial body of evidence suggests clinicians miss/underestimate AEs experienced by patients. The added value of patient symptom and AE self-reports is recognised, but is rare in early phase clinical trials (EPCT). Electronic methods provide an innovative way of capturing this information reliably and easily. \n\nAim: The overall aim is to explore the implementation of an ePRO-trial system that incorporates electronic linkage/integration with a clinical trial database in an EPCT. We have already undertaken a qualitative phase to explore the issues in this area. A pilot study will now explore the use of ePRO AE reporting system in EPCTs. \n\nMethod: A convenience sample of oncology/haematology patients enrolled on academic EPCTs (Phase I or II) will be recruited during a 12 month period. Participants will be reminded to complete an online PRO AE questionnaire weekly (5-10 minutes) for a maximum of 12 weeks. They will have access to complete at other times should they experience symptoms they wish to report. Patient involvement with this study will be in addition to attending usual clinical/trial-related appointments. Patient compliance and satisfaction will be explored. The research team will receive notifications for severe (grade 3+) symptoms to test the reliability of the notifications. \n\nOutcomes: \n- Initial information on patient and clinicians views on ethical/logistical issues related to electronic AE reporting in EPCT.\n- A pilot tested system with information on patient compliance and feasibility in EPCTs.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0204
Date of REC Opinion
29 Jun 2018
REC opinion
Favourable Opinion