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
Summary of Research
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.
Summary of Results
This study looked at whether using the Vinehealth digital health app, alongside standard NHS care, could improve how people feel physically during chemotherapy or reduce their need for healthcare services. The study included 173 patients who were starting chemotherapy for breast, colorectal, or lung cancer across several NHS hospitals. About half of the participants used Vinehealth in addition to their usual care, while the other half received standard care alone. Patients were followed for up to 24 weeks after starting treatment. The two groups were very similar at the start of the study in terms of age, sex, cancer type, and cancer stage. This means the results provide a fair comparison between people who used the app and those who did not.The main outcome of the study was physical wellbeing at 12 weeks, measured using a widely used patient questionnaire. Both groups showed changes in physical wellbeing over time, which is expected during chemotherapy. However, there was no meaningful difference between people using Vinehealth and those receiving standard care alone. This finding was consistent when looking at all patients together and when looking separately at people with breast or colorectal cancer. In simple terms, using the Vinehealth app did not lead to people feeling physically better than usual care alone during chemotherapy.
The study also looked at overall quality of life, including general health, daily functioning, and how patients rated their own health. Across all these measures and time points, the results were very similar between the two groups. Although one measure showed a difference at a single time point, this was not seen at other times and is likely due to chance rather than a real effect. Overall, Vinehealth did not show a clear improvement or decline in quality of life compared with standard care.
In addition, the study examined whether Vinehealth reduced the use of healthcare services. This included emergency department visits, calls to acute oncology teams, GP appointments, hospital admissions, and length of hospital stay. The results showed no meaningful differences between the two groups. People using Vinehealth used healthcare services at similar rates to those receiving standard care, suggesting the app did not reduce demand on NHS services during the study period.
The Vinehealth app was found to be safe to use. No safety issues were linked to the app itself. However, more participants stopped using Vinehealth compared with those in the standard care group. Most withdrawals were due to personal choice or practical reasons rather than medical concerns.
In summary, this study found that adding the Vinehealth app to standard care during chemotherapy did not improve physical wellbeing, overall quality of life, or reduce healthcare use compared with standard care alone. While the app was safe, it did not demonstrate additional clinical benefit in this trial setting
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