RCT of Vinehealth® digital health cancer solution
Research type
Research Study
Full title
Multi-centre, randomised controlled trial of Vinehealth® digital health cancer solution for cancer patients commencing chemotherapy
IRAS ID
300753
Contact name
Agnieszka Michael
Contact email
Sponsor organisation
University of Surrey
ISRCTN Number
ISRCTN44293246
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Global cancer deaths are projected to increase 45% by 2030. Rising survival means many patients remain on long-term toxic treatments for \>10 years, so improving Quality of Life (QoL) for cancer patients is crucial. This presents an urgent and growing need for personalised tools to support cancer patient self-management and data collection to enable monitoring and remote follow-up.
Currently, patient information and support is dispersed, inaccessible and poorly personalised.Majority of patients receive a written information and a brief session with a doctor or a specialised nurse to explain the side effects of chemotherapy and the schedule of treatment . The management of side effects varies between the care providers with some hospitals offering access to 24hr chemotherapy hotline and other hospitals providing only 9-5 hrs advice. Macmillan's Cancer Patient Experience Survey (2020) reported 39% patients stated treatment side-effects were not explained in a way they could understand. 44% were not offered individual information and support in dealing with side-effects. Macmillan report that GPs are not able to take on this care, given workforce pressures.
Vinehealth® is a highly innovative solution meeting these unmet needs. Vinehealth®'s digital platform combines behavioural science and AI to improve cancer patient experience, care delivery and clinical outcomes. Vinehealth®'s patient-facing mobile app collates information from partners across the cancer ecosystem, deploying Machine Learning (ML)-driven personalised support to enable better self-management of medications, side-effects, symptoms and lifestyles, seamlessly integrating with smartphones and wearables.
The project objectives are to undertake sufficiently large Randomised Clinical Trial (RCT) to provide robust evaluation of claims that Vinehealth®'s platform can effectively: 1. Collect Patient Reported Outcomes (PRO) data in clinical studies 2. Improve patient self-management 3. Reduce emergency healthcare utilisation.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
22/ES/0007
Date of REC Opinion
16 Mar 2022
REC opinion
Further Information Favourable Opinion