1835P - Multi-centre, randomised controlled trial of digital health cancer solution for cancer patients receiving chemotherapy

Background

Digital chemotherapy app (Vinehealth®) is an innovative digital platform that combines behavioural science and artificial Intelligence to improve cancer patient experience and care delivery. It is a patient-facing mobile app that collates information from partners across the cancer treatment centres and Machine Learning driven personalised support to enable better self-management of medications, side-effects, symptoms and lifestyles.

Methods

Patients undergoing adjuvant chemotherapy for breast, lung and colorectal cancer were randomised to use the app or to the standard of care. The primary endpoint was QOL assessed by FACT-G (PWB) at 12 weeks. Secondary endpoints looked at the improvement of patients’ compliance with Patient Reported Outcomes data collection using FACT-G (PWB), EQ-5D-5L and EORTC QLQ-C30 at 6/12 and 18/24 weeks, resource use data, and qualitative assessment tool to assess patients’ and health professionals’ views. 2 points difference on FACT-G (PWB) was considered meaningful, 126 evaluable patients were needed for 80% power with significance level of 0.05.

Results

173 patients with breast (68.2%), colorectal (30.1%) and lung cancer (1.7%) were recruited. 140 (77 on the standard of care and 63 on the app arm) were evaluable. The QOL did not differ between arms (adjusted difference 0.37 95%CI (-1.62-2.36). There were no significant differences between the secondary endpoints of EQ5D and EORTC QLQ-C30 at all time points. Resource use data (A&E attendances and calls to acute oncology) showed no significant differences between arms. Majority of patients found the app easy to use, useful for tracking symptoms, temperature, feelings, and medication. Patients used it more during the first two cycles of chemotherapy and commented that it gave them the sense of control. Patients aged 75+ had almost double the average total logs per user compared to the 25-34 age bracket with both age brackets having a similar number of participants.

Conclusions

Use of electronic chemotherapy app (Vinehealth®) does not improve the quality of life but patients find it a useful tool to use during their treatment. An addition of clinician’s portal is currently being evaluated.

Clinical trial identification

IRAS number, 300753; ISRCTN number 44293246.

Editorial acknowledgement

Legal entity responsible for the study

University of Surrey, Surrey Clinical Trials' Unit.

Funding

UKRI Innovate UK Biomedical Catalyst 2020.

Disclosure

A. Michael: Financial Interests, Personal, Advisory Board: EUSA Pharma, Tesaro; Financial Interests, Personal, Invited Speaker: GSK, Ipsen, Clovis, Novartis, Pfizer; Financial Interests, Personal, Other, travel, accomodation: Merck; Financial Interests, Personal, Other, conference attendance: Ipsen; Financial Interests, Local PI: CARINA Trial, Vinehealth, OVAL-1; Financial Interests, Institutional, Local PI: MODIFY. S. Popat: Financial Interests, Personal, Full or part-time Employment, User Expereince Manager: VInehealth. R. Patel, G. Kirby: Financial Interests, Personal, Stocks or ownership: VInehealth; Financial Interests, Personal, Full or part-time Employment: Sciensus. M. Kelly: Financial Interests, Personal, Full or part-time Employment: VInehealth. A.H. Montazeri: Financial Interests, Institutional, Advisory Board: Seagen, Servier; Non-Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Personal, Advisory Role: Servier. R. Shah: Financial Interests, Personal, Advisory Board, Advisory board + speaker roles: BMS; Financial Interests, Personal, Advisory Board, Ad board and speaker roles: Boehringer Ingelheim, AstraZeneca, Roche, MSD, Pfizer, Lilly, Novartis, Takeda, Bayer, Beigene, Guardant, Sanofi, EQRx, Merck; Financial Interests, Personal, Other, specialist advisor: Genesiscare; Non-Financial Interests, Leadership Role, Steering committee member: BTOG. R. Bowen: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca, MSD, Clovis, Eisai, PharmaAnd. All other authors have declared no conflicts of interest.