The BrainApp Study is a digital health, multi-centre, observational, non-randomised phase II trial for adult primary brain tumour (BT) patients and healthy volunteers (HVs) in the UK.
The aim of this study is to assess the feasibility, acceptability, and performance of a mobile app, BRIAN, developed by The Brain Tumour Charity, in collecting data on speech, quality of life, physical activity and sleep, for predicting disease progression in adult BT patients.
Subjects will be those aged 16 and above; formally diagnosed with a primary BT (patients only); fluent English speakers; willing and able to undertake study specific measures; and of WHO performance status 0, 1 or 2 (patients only). Patients will be recruited from NHS cancer centres. HVs will consist of members of the public (can be patient caregivers) who are recruited solely via BRIAN. Participants will be required to enter their speech data on BRIAN along with other information at pre-specified intervals for up to two years.
All participants would need to download BRIAN on to their mobile devices. Once registered, participants will need to tap on "Help us improve treatment and care" on their BRIAN Home screen then "Clinical trial data sharing" followed by the plus sign. When prompted, HVs will enter trial referral code "HV0001". Patients will enter the trial code of their respective hospitals e.g. Imperial College Healthcare NHS Trust patients enter code "BAIMPP1". The participant information sheet and consent form can be accessed and signed entirely on BRIAN.
Once participants have entered their age, sex, qualification, medication, and handedness information, they can link their fitness trackers and play mini mobile games (called Challenges) on BRIAN. The mini games assess speech, coordination, visual memory and facial features over time and are to be done monthly at a minimum. They only take less than 5 minutes to do, can be done anytime and anywhere quiet. For patients, they will also record their tumour log, quality-of-life (via "Help us improve treatment and care" -> Questionnaires and Surveys -> Adult Quality of Life Questionnaire EORTC), treatments and investigations.
Researchers will record patient information not captured by BRIAN in electronic case report forms and transfer patient brain imaging to the study management centre at Imperial College London. Data will be analysed using speech processing, repeated measures statistical, traditional machine learning, and deep learning methods.
BrainApp opened for recruitment on September 2022.
Download BRIAN here or scan the QR code below.