Pilot randomised trial of online self-monitoring of symptoms during pelvic radiotherapy eRAPID approach (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice)


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Galina Velikova1,Patricia Holch2,Kate Absolom1,Katrina Walker1,Rose Peacock1,Simon Pini1,Susan Davidson3,Jacki Routledge3,Ann M Henry1,Kevin Franks1,Claire Hulme1,Carolyn Morris4,Lucy McParland1,Julia Brown1
1University of Leeds,2Leeds Beckett University,3The Christie Hospital Manchester,4NCRI Consumer Forum

Abstract

Background

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. eRAPIDapproach 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 RCT and refine the intervention.

Method

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/hormonotherapy 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-QLQ-C30), 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 Dec2016-June2018, 502 patients from Leeds Cancer Centre & Christie Hospital,Manchester were screened for eligibility, 228 were approached, 167 consented (73.2%)& were randomized (83-eRAPID,84-UC); 87-prostate,45-gynaecological, 34-lower gastrointestinal cancers. Withdrawals 16/228=7% (10-eRAPID,6-UC).

Patient compliance with online self-reports was 82% of expected week 1, 63% week 12. Return rates of outcome measures-99.8% at baseline,77.8% at 18 & 73.7% at 24 weeks.

eRAPID patients reported less deterioration overtime (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 eRAPID online intervention is acceptable & 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 multi-centre RCT trial.