Primary and secondary brain tumours Cancer High-grade glioma (HGG) Low-grade glioma (LGG) Metastatic brain cancer
Conditions
Interventions
The study idea originated from a patient undergoing treatment for a brain tumour, and has undergone structured patient and public involvement (PPI) with feedback incorporated into the protocol. Exper
low-grade tumour for surgery alone
brain metastasis for surgery and/ or SRS) with matched healthy volunteers (main caregiver)). Within a 1 year period we typically treat > 50 patients with primary brain tumours having chemo-radiotherap
Review of patient telephone and installation of Moves Application. The Moves App will be correlated with the AX3 device data to assess for similarities in data collection in a mobile ve
Sponsors
Imperial College NHS Healthcare Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary or secondary brain tumours recently diagnosed and about to start treatment (unless matched healthy volunteers) 2. Patients with histology or clinically proven primary or secondary tumours who are fit to have radical treatment including surgery, radiotherapy or chemotherapy (unless matched healthy volunteers) 3. If being treated for recurrent tumour then at least 6 months must have elapsed since the completion of previous treatment (unless matched healthy volunteers) 4. Able to provide written informed consent 5. Fluent in English 6. Willing to undertake trial-specific measures, including wearing of and upload of data from wristband. 7. Aged over 18 years and 90 years or under Patients do not need a smart phone to be eligible for this study
Exclusion criteria
Exclusion criteria: 1. Patient undergoing WBRT 2. Patients with poor PS (PS3, 4) undergoing palliative treatments 3. Patients who have recently completed treatment (within 6 months) for primary or metastatic brain tumour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Compliance and acceptability in patient use of devices, measured as >=50% data completeness in patients at 3 months post enrolment. 2. Patient physical activity, monitored over the period of time in which the participant is enrolled into the trial. Patients will be followed from their first hospital appointment until either they reach PS 3 for more than 2 weeks, until they have been off-treatment with stable disease for 6 months, or they choose to withdraw from the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be measured at enrolment, week 2 (+/- 7 days), week 6 (+/- 14 days), week 8 (+/- 7 days), week 10 (+/- 7 days), week 14 (+/- 14 days), week 18 (+/- 14 days), week 22 (+/- 14 days), and then 3 monthly until either patient becomes PS 3, until they have been off-treatment with stable disease for 6 months, or withdraws from study, along with at any unexpected visits: 1. Quality of life scores (EORTC QLQ C-30 and BN-20) 2. Performance status (PS), measured using ECOG scale 3. Imaging (standard imaging as clinically indicated) measured with 3 MRI and Contrast Head scans, reported using RANO criteria 4. Self reported fatigue and activity (MFI) measured using the MFI scale 5. Medication and steroid dose, monitored through documentation by the study team of any changes in medication since the last study review 6. Disease progression will be measured using MRI head imaging every 3 months until the patient becomes PS 3, until they have been off-treatment with stable disease for 6 months, or until they withdraw from the study, along with any unexpected visits. | — |
Countries
United Kingdom
Outcome results
None listed