Pilot randomized trial of online self-monitoring of symptoms during pelvic radiotherapy

Abstract

Purpose/Objective(s): Radiotherapy for pelvic cancers increases survival but has serious short and long-term pelvic-related adverse effects (AEs). Active monitoring and timely management of the acute AEs may improve patient experiences. eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) approach uses a secure online system for patients to report AEs, providing either self-management suggestions or advice for hospital contact. This randomized feasibility/ pilot study aimed to establish feasibility, recruitment/attrition rates, select a primary outcome measure for a future randomized controlled trial (RCT) and refine the intervention. Materials/Methods: A prospective two-center randomized (1:1 intervention or usual care (UC)) parallel group trial with repeated measures and mixed methods. Eligible patients were undergoing pelvic radiotherapy+/- chemotherapy/hormone therapy for prostate, lower gastrointestinal and gynecological cancers. Participants randomized to eRAPID reported AE from home weekly for 12 weeks, and then at 18 &24 weeks. We measured and analyzed descriptively: Patient-reported outcomes (validated questionnaires: FACT-G, EORTC-QLQ-C30), process of care (hospital records of patient contacts/admissions); economic measures (EQ5D-5L). Semistructured interviews were conducted with staff and patients with thematic analysis. ClinicalTrials.gov NCT02747264. Results: Between 2016 and 2018, 502 patients from two UK centers were screened for eligibility, 253 approached and 228 found to be eligible, 167 consented (73.2%) and were randomized (83-eRAPID,84-UC); 87-prostate, 45-gynaecological, 34-lower gastrointestinal cancers. Withdrawals were 16/167 Z 9.6% (10-eRAPID,6-UC). Patient compliance with online self-reports was 82% of expected at week 1, 63% at week 12. Return rates of outcome measures-95.8% at baseline, 77.8% at 18 and 73.7% at 24 weeks. eRAPID patients reported less deterioration over time (biggest difference at 6 weeks): FACT-G mean change-score: eRAPID -2.9 (s.d.11.6); UC -7.6 (s.d.10.5); QLQ-C30 summary-score change: eRAPID -6.3 (s.d.11.8); -10.7 (s.d.13.8). The score changes were larger in chemoradiotherapy patients. Similar trends were seen for EQ5D. The system was acceptable to patients and staff. Clinicians recommended longer online monitoring. Conclusion: This pilot RCT confirmed the intervention is acceptable and recruitment is feasible (consent rate of >70%, withdrawal <10%; online completions 60-70%). Patient outcome measures suggest potential benefit in the chemo-radiotherapy groups, but this needs confirmation in a formally powered RCT. This is independent research was funded by the UK National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (reference number RP-PG-0611- 20008). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.