Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy

Abstract

PURPOSE Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent. METHODS Patients with colorectal, breast, or gynecological cancers commencing chemotherapy were randomly assigned to usual care (UC) or the addition of eRAPID (weekly online symptom reporting for 18 weeks). Primary outcome was symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB]) assessed at 6, 12, and 18 weeks. Secondary outcomes were processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy–General, EQ5D-VAS, and EORTC QLQ-C30 summary score). Multivariable mixed-effects repeated-measures models were used for analyses. Trial registration: ISRCTN88520246. RESULTS Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals. eRAPID compared to UC showed improved physical well-being at 6 ( P = .028) and 12 ( P = .039) weeks and no difference at 18 weeks (primary end point) ( P = .69). Fewer eRAPID patients (47%) had clinically meaningful physical well-being deterioration than UC (56%) at 12 weeks. Subgroup analysis found benefit in the nonmetastatic group at 6 weeks ( P = .0426), but not in metastatic disease. There were no differences for admissions or chemotherapy delivery. At 18 weeks, patients using eRAPID reported better self-efficacy ( P = .007) and better health on EQ5D-VAS ( P = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician's data use and improved FACT-PWB at 12 weeks. CONCLUSION Real-time monitoring with electronic patient-reported outcomes improved physical well-being (6 and 12 weeks) and self-efficacy (18 weeks) in a patient population predominantly treated with curative intent, without increasing hospital workload.

The GIMEMA-ALLIANCE Digital Health Platform for Patients With Hematologic Malignancies in the COVID-19 Pandemic and Postpandemic Era: Protocol for a Multicenter, Prospective, Observational Study

“…The current pandemic represents an opportunity to further boost use of digital health technologies in the hematology arena and maximize the use of remote ePRO data collection in patients with hematologic malignancies. As recently observed, the COVID-19 pandemic has precipitated a shift to remote technology-enabled care [24].…”

“…Similarly, another RCT in patients with advanced-stage lung cancer showed that a web-mediated follow-up algorithm based on self-reported symptoms also improved overall survival [23]. A more recent RCT conducted in patients with solid cancer, who were mainly treated with curative intent, showed that real-time monitoring with ePROs improved physical well-being and self-efficacy without increasing hospital workload, and authors concluded that online symptom monitoring is a feasible approach to be implemented in routine care [24].…”

A narrative review of current evidence supporting the implementation of electronic patient-reported outcome measures in the management of chronic diseases

“… 33 However, no significant difference was recorded at 18 weeks between the two arms of the study ( p = 0.699). 33 …”

“…Conversely, in the United Kingdom (UK), the RCT of the eRAPID system by Absolom et al did not find any significant difference in the utilisation of healthcare resources between the intervention and control arms. 33 Specifically, there were no significant differences in chemotherapy delivery, hospital admissions, acute oncology assessments or emergency hotline calls. 33 …”

“… 33 Specifically, there were no significant differences in chemotherapy delivery, hospital admissions, acute oncology assessments or emergency hotline calls. 33 …”