Phase III randomized controlled trial of eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and advice)—An eHealth intervention during chemotherapy.

Abstract

7002 Background: Routine monitoring of patients’ symptoms can improve symptom management, quality of life (QOL) and survival. eRAPID is an online system for patients to report symptoms, uniquely providing automated severity-dependent advice (self-management or alerts for hospital contact). We evaluated eRAPID impact on patient experiences & clinical care. Methods: A prospective randomized two-arm parallel group trial (1:1 allocation Usual Care (UC): UC+eRAPID). Eligible patients started chemotherapy for colorectal, breast & gynecological cancers at Leeds Cancer Centre. In eRAPID arm, patients completed weekly online symptoms for 18 weeks. Primary outcome: QOL/symptom control (FACT-PWB Physical Wellbeing Scale) at 18 weeks. Secondary outcomes: process of care (admissions/ chemotherapy delivery), patient self-efficacy (Lorig Self-Efficacy Scale) & global QOL (EQ5D).Mixed effects repeated measures models were employed. Results: During Jan 2015-June 2018, we screened 1484 patients; 508/690 eligible patients (73.6%) consented & were randomized (256 eRAPID:252 UC). No statistically significant effect of eRAPID on FACT-PWB score was found at 18 weeks (difference in means 0.20 95% CI -0.81, 1.20; p = 0.699). There was a positive impactat 6 & 12 weeks (1.08, 95% CI 0.12, 2.05; p = 0.028 & 1.01, 95% CI 0.05, 1.98; p = 0.039).In responder analysis lower proportion of eRAPID patients had clinically meaningful deterioration 47.5% at 12 weeks vs 56.3% UC. Pre-planned subgroup analysis found no effect in metastatic disease, but better FACT-PWB in non-metastatic/adjuvant group at 6 & 12 weeks (1.45, 95% CI 0.32, 2.58; p = 0.011 & 1.13; 95% CI 0.07, 2.19; p = 0.036). eRAPID patients reported better self-efficacy (p = 0.007) & QOL EQ5D-VAS at 12 (p = 0.030) & 18 weeks (p = 0.010). There were no differences for admissions/chemotherapy delivery. 3314 online reports were completed, median per patient 14.0 (range 0-117). Emergency alerts were activated in 29/3314 cases (0.9%), self-management advice 2714/3314 (81.9%). Post-hoc analysesshowed high patient adherence was associated with clinicians’ use of the data, high baseline FACT-PWB & older age. High adherence patients had better FACT-PWB scores at 12 weeks. Conclusions: Online symptom monitoring with immediate advice improved symptom control early during adjuvant chemotherapy (6 &12 weeks), helping patient education & self-efficacy. The results support its utility as an improved model for patient care during adjuvant chemotherapy. Clinical trial information: ISRCTN88520246 .