Online symptom monitoring during pelvic radiotherapy: randomised pilot trial of eRAPID intervention

Abstract

Background: Radiotherapy and chemo-radiotherapy for pelvic cancers increase survival but are associated with serious treatment-related symptoms. Electronic-patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is a secure online system for patients to self-report symptoms, generating immediate advice for hospital contact or self-management. This pilot study aimed to establish feasibility and acceptability of the system. Methods: In a prospective two-centre randomised parallel-group pilot study. Patients undergoing radical pelvic radiotherapy for prostate cancer (prostateRT) or chemo-radiotherapy for lower gastrointestinal and gynaecological cancers (chemoRT) were randomised to usual care (UC) or eRAPID (weekly online symptom reporting for 12, 18 & 24 weeks). Primary outcomes were recruitment/attrition, study completion and patient adherence. Secondary outcomes were impact on hospital services and performance of patient outcome measures. Missing data, floor/ceiling effects, and mean change scores were examined for FACT-G, EORTC-QLQ-C30, self-efficacy, EQ5D-5L. Results: From 228 patients approached, 167 (73.2%) were consented and randomised (83-eRAPID,84-UC;87-prostateRT;80-chemoRT). 150/167 completed 24 study weeks. Only 16 patients (9.6%) withdrew (10-eRAPID; 6-UC). In the eRAPID arm, completion rates were higher in patients treated with prostateRT compared to chemoRT: week 1 93% vs 69%; week 2 93% vs 68%; week 12 69% vs 55%). Overall over 50% of online reports triggered self-management advice for milder AEs. Unscheduled hospital contact was low, with no difference between eRAPID and UC. Return rates for outcome measures were excellent in prostateRT (97%-91%; 6-24 weeks) but lower in chemoRT (95%-55%; 6-24 weeks). Missing data was low (1%-4.1%), ceiling effects were evident in EQ5D-5L, self-efficacy-scale and FACT-PWB. At 6-weeks the chemoRT-eRAPID group showed less deterioration in FACT-G, EORTC QLQ-C30 and EQ5D-VAS than UC, after baseline adjustment. Conclusions: eRAPID was successfully added to UC at two cancer centres in different patient populations. Acceptability and feasibility was confirmed with excellent adherence by prostate patients, but lower by those undergoing chemoRT for gynaecological cancers.