At a glance
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Measuring and Mapping Cognitive Decline After Brain Radiosurgery: a Pilot Study
In Brief
An observational study evaluating Neurocognitive testing, Quality of Life questionnaire, and 1 other intervention for Brain Metastases and 5 related conditions. Active but no longer recruiting, targeting 80 participants across 1 site.
Detailed Summary
Background Stereotactic Radiosurgery (SRS) is a localised radiotherapy treatment for patients with brain metastases or other benign tumours in the brain, like meningiomas. The Investigators do not currently know if, or how much, SRS affects brain function. Patients with brain tumours do not get tested routinely for their brain function. Understanding short- and long-term side-effects is important for SRS. Brain metastases patients have short life expectancies (6-months to 1-year). However, meningioma patients can live 10 years or more. SRS is used to treat both. The Montreal Cognitive Assessment will be used to test the participants' brain function. Quality-of-life questionnaires QLQ-C30 and BN20 will also be used to assess the participants' physical and mental wellbeing . These are specific for patients with brain cancer. Why is it important This study aims to identify areas in the brain that relate to changes in brain function after SRS. These areas can then have the radiation dose reduced to them in future patients, hoping to minimise side-effects. Research Question Which regions of the brain contribute to a decline in brain function following SRS. Study Design This is a single centre observational study with prospective and retrospective collection of data. This study will look at two groups of patients: Group1: Patients will complete the MoCA and two quality-of-life questionnaires before the treatment and every 3 months for a year. Group2: Patients will complete the MoCA and two quality-of-life questionnaires once. The investigators will use these tests, MRI scans and the SRS treatment plan to identify areas of the brain that are responsible for any problems with the participants' brain function. The participants for Group 1 will be recruited from the SRS Clinics, at City Campus, Nottingham University Hospitals NHS Trust. The participants for Group 2 will be identified through the Mosaiq Oncology Information System. This pilot study is funded by the Midlands Mental Health and Neurosciences Network.
Study Details
Timeline
Interventions
The MoCA is a brief tool developed to screen mild cognitive impairment and has been validated in patients aged 55-85 years old. It has been tested and validated in patients with brain metastases, and its acceptability has been tested in the general brain tumour population. The paper version of the MoCA is available in nearly 100 languages. The online version is available currently in 5 languages.
The EORTC-QLQ-C30 is a quality-of-life questionnaire that was developed by the European Organisation for Research and Treatment of Cancer (EORTC) for use in clinical trials. It is a 30-item questionnaire that incorporates the following five scales: physical, role, cognitive, emotional and social. It has also been validated and is available in more than 100 languages. The EORTC-QLQ-BN20 is a questionnaire that was developed for use specifically with patients that have brain cancer. The BN20 is a 20-item questionnaire and addresses four different scales (multi-item): future uncertainty, visual disorder, motor dysfunction and communication deficit. There are seven items that assess physical symptoms: headaches, seizures, drowsiness, hair loss, itchy skin, weakness of legs and bladder control. The questionnaire has been validated in over 15 languages. The two questionnaires are meant to complement each other when used in patients with brain cancer.
This is a Standard of Care treatment for all the patients that will be recruited in both cohorts. Stereotactic radiosurgery will be delivered to one or more sites and in the prospective cohort can be delivered more than once.