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.
Background Ovarian cancer patients require monitoring for relapse. Innovative follow-up methods are increasingly being explored. An electronic patient-reported outcome (ePRO) follow-up pathway was developed for women treated for ovarian cancer. This feasibility study explored patient acceptability and compliance. Methods A single-arm non-blinded prospective feasibility study was undertaken at two hospitals. Participants were women who had completed treatment for ovarian cancer whose clinician was happy for them to be monitored remotely. Automated 3-monthly reminders were sent to participants to complete an ePRO questionnaire and obtain blood tests. Participants were reviewed over the phone by their clinical nurse specialist instead of attending clinic-based follow-up. The primary outcome was compliance (expected ePRO completions/blood tests) across the 12-month study period. Secondary outcomes were recruitment, attrition, resource use, symptom severity/alerts and patient acceptability. Results Twenty-four women consented (50% consent rate), and 13 remained on study at 12 months. Seven women relapsed, 3 chose to withdraw, and 1 withdrew for other clinical reasons. ePRO compliance was high and consistent at 75-82%, although the two hospitals differed. Adherence to the clinical protocol was evident for blood tests and contacts with staff (fewer visits, more phonecalls compared to an earlier audit). End-of-study feedback indicated high patient satisfaction. Conclusions Remote ePRO follow-up for ovarian cancer is feasible and acceptable to patients who are able and willing to participate. However, the low recruitment rate (ineligible + declined) indicate it is not suitable/acceptable to all patients immediately post-treatment. Further large-scale research and implementation work is required, especially in a post-COVID era. Trial registration ClinicalTrials.gov ID: NCT02847715 (first registered 19/05/2016).
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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 .
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