Electronic collection of cancer patient-reported outcomes using a novel digital oncology platform: A multi-site randomized controlled trial.
Authors: Fidyk Chris , Popat Serena , Tay Nicole , Smith Luke , Bowen Rebecca , Khawaja Saira , Leonard Pauline , Montazeri Amir , Peck Rahul , Raslan Ahmad , Ridley Paul , Thandar Hasina , Skene Simon , Kirby Georgina , Patel Rayna , Michael Agnieszka 
Published: June 2023

TPS1614

Background: Cancer is the leading contributor of disease burden worldwide, and incidence rates are estimated to rise 47% by 2040. With increasing numbers of people living with cancer, alongside healthcare workforce shortages, current models for cancer monitoring and surveillance are unsustainable. Within the UK’s National Health Service (NHS), this is exacerbated by a rising backlog following the COVID-19 pandemic. Furthermore, a 2020 Macmillan Cancer Support survey showed that current patient information and support is scattered, inaccessible, and poorly personalized. There is an urgent need for effective personalized tools to support cancer patient self-management and data collection to enable healthcare professional (HCP) monitoring and remote follow-up. Methods: A multi-site randomized controlled trial is underway within the NHS to evaluate the implementation of a novel digital oncology platform (Vinehealth) for personalized support. Vinehealth consists of a mobile patient application, integrated wearables data, and a clinician dashboard. The study aims to recruit 180 patients across 8 NHS Trusts diagnosed with (i) colorectal, breast, or lung cancer undergoing adjuvant systemic treatment (chemotherapy +/- targeted therapies) post surgery, or (ii) asymptomatic breast cancer undergoing neoadjuvant treatment. A power calculation was conducted relating to the primary objective demonstrating the efficacy in improvement of QoL in the interventional arm, providing 80% power and at a significance level of 0.05. Enrolled patients will be randomized (1:1) between standard of care (SoC) and interventional arms (SoC plus Vinehealth platform). The main objective is to assess if implementation of Vinehealth improves patients’ quality of life (QoL) compared to SoC based on EQ-5D-5L, EORTC QLQ-C30, and FACT-G (PWB) questionnaires. Secondary objectives include assessing patient compliance with electronic patient-reported outcome (ePRO) data collection and patient self-management of symptoms. The study will further evaluate whether Vinehealth improves the process of care (assessed through medication adherence) and reduces emergency healthcare utilization (including ED/GP visits/admissions and acute oncology hotline use). Questionnaires are completed by all patients at baseline, 6, 12, 18 and 24 weeks. Qualitative interviews will be conducted with a subset of interventional arm patients and HCPs from each NHS Trust to understand engagement with the Vinehealth platform. To our knowledge, this is the first multi-site RCT within the NHS to evaluate the impact of a digital oncology platform on cancer patients’ QoL, ePRO compliance, process of care, and healthcare utilization. The trial is expected to end by September 2023 with results being reported in January 2024. Clinical trial information: ISRCTN44293246 .