eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: a pilot study protocol in pelvic radiotherapy

Abstract

BackgroundAn estimated 17,000 patients are treated annually in the UK with radical radiotherapy (RT) for pelvic cancer. New treatment approaches in RT have increased survivorship and changed the subjective toxicity profile for patients who experience acute and long-term pelvic-related adverse events (AE). Multi-disciplinary follow-up creates difficulty for monitoring and responding to these events during treatment and beyond. Originally developed for use in systemic oncology therapy eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to report AEs from home. eRAPID enables patient data to be integrated into the electronic patient records for use in clinical practice, provides patient management advice for mild and moderate AE and advice to contact the hospital for severe AE. The system has now been developed for pelvic RT patients, and we aim to test the intervention in a pilot study with staff and patients to inform a future randomised controlled trial (RCT).MethodsEligible patients are those attending St James’s University hospital cancer centre and The Christie Hospital Manchester undergoing pelvic radiotherapy+/−chemotherapy/hormonotherapy for prostate, lower gastrointestinal and gynaecological cancers. A prospective 1:1 randomised (intervention or usual care) parallel group design with repeated measures and mixed methods will be employed. We aim to recruit 168 patients following recommendations for sample size estimates for pilot studies. Participants using eRAPID will report AE (at least weekly) from home weekly for 6 weeks and 6 weeks post-treatment (12-week total) then at 18 and 24 weeks. Hospital staff will review eRAPID reports and use information during consultations. Notifications will be sent to the relevant clinical team when severe symptoms are reported. We will measure patient-reported outcomes using validated questionnaires (Functional Assessment in Cancer Therapy Scale-General (FACT-G), European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC-QLQ-C30), process of care impact (hospital records of patient contacts and admissions) and economic variables (EQ5D-5L, patient use of resources)). Staff and patient experiences will be explored via semi-structured interviews.DiscussionThe objectives are to establish feasibility, recruitment, integrity of the system and attrition rates, determine effect sizes and aid selection of the primary outcome measure for a future RCT. We will also refine the intervention by exploring staff and patient views. The overall goal of this complex intervention is to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets.Trial registrationClinicalTrials.gov NCT02747264.Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0304-6) contains supplementary material, which is available to authorized users.

Developing a real-time electronic symptom monitoring system for patients after discharge following cancer-related surgery

“…Algorithms can be programmed into the self-report scoring (in QTool), allowing severity-specific tailored self-management advice to be provided to patients and email notifications sent to allocated clinicians. The system was initially developed for patients undergoing systemic therapy and radiotherapy [30–32].…”

A real-time electronic symptom monitoring system for patients after discharge following surgery: a pilot study in cancer-related surgery

“…cancer nurse specialists (CNS), dietitians and surgeons) responsible for routine' post-discharge care. The development of the ePRO system and the electronic hosting platform has been described in full elsewhere [34][35][36]. The IT elements, developed in the eRAPID study [36], include a patient website with secure login function, web-based symptom-report questionnaire software (QTool) and a web application interface for secure transfer of data to EHR, enabling clinicians to view symptomreports.…”

“…Methods for collecting health resource use data were explored. Patients were asked to complete a health resource use questionnaire [35] at the end of the study (9 weeks post-discharge). The questionnaire included items to record use of prescription and non-prescription medication and other costs associated with patients' recovery from surgery.…”

Home-based Anti-Tuberculosis Treatment Adverse Reactions (HATTAR) study: a protocol for a prospective observational study

“…However, patient self-reporting rates and awareness are still low 40. In recent years, many electronic methods have been used to increase reporting rates, especially in cancer treatment,41–43 but those methods are obviously inappropriate for Chinese rural patients in a developing country. In the present study, a method combining active self-recorded diaries and passive scheduled laboratory tests was used to enhance the identification of adverse reactions.…”