Professor Galina Velikova, MD of the Leeds Institute of Medical Research discusses the ASCO abstract Phase III randomized controlled trial of eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and advice)"An eHealth intervention during chemotherapy
Bottom line:
Routine monitoring of the symptoms of patients may improve control of symptoms, quality of life ( QOL), and survival. ERAPID is an online patient reporting system, offering uniquely automated, severity-dependent guidance (self-management or hospital contact alerts). We measured the effect of eRAPID on patient experience & clinical treatment.
Methodology:
A prospective randomized trial of the two-arm parallel-group (1:1 Normal Treatment (UC) allocation: UC+eRAPID). At Leeds Cancer Centre, qualifying patients began chemotherapy for colorectal, breast & gynecological cancers. Patients had weekly online symptoms for 18 weeks in the eRAPID arm. Primary outcome: 18 weeks of QOL / symptom management (FACT-PWB physical health scale). Secondary outcomes: treatment process (admissions/chemotherapy delivery), self-efficacy of patients (Lorig Self-Efficacy Scale) & global QOL (EQ5D). Mixed-effects were used to model repeated steps.
Reviews:
We checked 1484 patients between January 2015-June 2018; 508/690 eligible patients (73.6 percent) consented & were randomized (256 eRAPID:252 UC). At 18 weeks, there was no statistically significant impact of eRAPID on FACT-PWB score (difference in mean 0.20 95 percent CI -0.81, 1.20; p = 0.699). A positive effect occurred at 6 & 12 weeks (1.08, 95 percent CI 0.12, 2.05; p = 0.028 & 1.01, 95 percent CI 0.05, 1.98; p = 0.039). Lower proportion of eRAPID patients had clinically significant decline in response examination 47.5 percent at 12 weeks vs 56.3 percent UC. There was no effect on metastatic disease in the pre-planned subgroup study, but increased FACT-PWB in the non-metastatic / adjuvant group at 6 & 12 weeks (1.45, 95 percent CI 0.32, 2.58; p = 0.011 & 1.13; 95 percent CI 0.07, 2.19; p = 0.036). Better self-efficacy (p=0.007) & QOL EQ5D-VAS at 12 (p=0.030) & 18 weeks (p=0.010) were recorded by eRAPID patients. There were no differences between admissions and the administration of chemotherapy. 3314 online reports were completed, with a median of 14.0 (range 0-117) per patient. In 29/3314 cases (0.9 percent), self-management guidance 2714/3314 (81.9 percent) emergency warnings have been triggered. High patient adherence was correlated with the use of data by physicians, high baseline FACT-PWB & older age. Patients with high adherence had stronger FACT-PWB scores at 12 weeks.
Conclusions Therein:
With immediate advice, online symptom monitoring enhanced symptom management early during adjuvant chemotherapy (6 & 12 weeks), aiding patient education & self-efficacy. The findings endorse its effectiveness in adjuvant chemotherapy as an enhanced model for patient treatment. Details on the clinical trials: ISRCTN88520246.