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

Abstract

Purpose or Objective Radiotherapy and chemo-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 randomised feasibility/pilot study aimed to establish feasibility, recruitment/attrition rates, select a primary outcome measure for a future randomised controlled trial (RCT) and refine the intervention. Material and Methods A prospective two-centre randomised (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 gynaecological cancers. Participants randomised to eRAPID reported AE from home weekly for 12 weeks,18 &24 weeks. We measured and analysed descriptively: Patient-reported outcomes (validated questionnaires: FACT-G, EORTC-QLQC30), process of care (hospital records of patient contacts/admissions); economic measures (EQ5D-5L). Semi-structured interviews were conducted with staff and patients with thematic analysis. Ethics approval Yorkshire &The Humber Leeds East Research Ethics Committee (REC reference 16/YH/0371, 13.09.2016). ClinicalTrials.gov NCT02747264. Results Between Dec 2016-June 2018, 502 patients from Leeds Cancer Centre and Christie Hospital,Manchester were screened for eligibility, 228 were approached, 167 consented (73.2%) and were randomized (83-eRAPID,84- UC); 87-prostate,45-gynaecological, 34-lower gastrointestinal cancers. Withdrawals were 16/228=7% (10-eRAPID,6-UC). Patient compliance with online selfreports was 82% of expected at week 1, 63% at week 12. Return rates of outcome measures-99.8% 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 chemo-radiotherapy 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 chemoradiotherapy 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.