Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
ConditionNeurocognitive Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
This is prospective observational registry study that will assess 1) if the neurocognitive function app (Brainlab Cognition) can be used in a widespread neuro-oncology clinic setting and 2) if patient reported quality of life parameters can be obtained electronically and integrated into clinic.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult (18+) patients with central nervous system (CNS) tumors, both primary brain malignancies and brain metastases, treated with radiotherapy (partial brain, stereotactic radiosurgery, stereotactic fractionated radiotherapy, or whole-brain radiotherapy), surgery, and/or antineoplastic therapy and followed thereafter at Miami Cancer Institute (MCI)
Life expectancy ≥ 6 months
Willingness to participate in ongoing registration study
Disqualifiers
Patients receiving radiotherapy to the brain for functional disease (arteriovenous malformations, trigeminal neuralgia, essential tremors, etc.)
Pediatric patients (<18 years old), pregnant women, and prisoners.
Trial population
All adult (18+) patients with CNS tumors, both primary brain malignancies and brain metastases, treated with radiotherapy (partial brain, stereotactic radiosurgery, stereotactic fractionated radiotherapy, or whole-brain radiotherapy), surgery, and/or antineoplastic therapy and followed thereafter at Miami Cancer Institute (MCI).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational study
Other interventionIt takes the patient on average 15 minutes to complete the Brainlab Cognition app.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in Learning and memory (Neurocognitive Decline)
Learning and memory will be assessed by the number of correct responses (the total number of words correctly recalled). The "Verbal Recall" test will be used to measure the number of correct responses over 3 trials, the "Verbal Revision" will be used to measure the number of total correct responses, and the "Verbal Recognition" test will be used to measure number of correct responses minus the incorrect responses. Change is calculated as baseline score subtracted from post-baseline score over time.
Time frame
Baseline, 2, 4, 6, 12, 18, 24 months2
Change in Attention and Speed of Processing (Neurocognitive Decline)
This will be measured by the "Symbols Matching" test. Subjects will be asked to match symbols and corresponding numbers during 90 seconds. The score will be calculated by totaling the number of correct answers during the allotted time. A higher score indicates better functioning.
Time frame
Baseline, 2, 4, 6, 12, 18, 24 months3
Change in Verbal Fluency (Neurocognitive Decline)
This will be measured by the "Words That Start With" test. The total number of words correctly generated (no numbers, no proper names) by the subject will be recorded to generate their score. A higher score indicates better functioning.
Time frame
Baseline, 2, 4, 6, 12, 18, 24 months4
Change in Fine motor and speed (Neurocognitive Decline)
This will be measured by the "Numbers Ordering" test. This test assesses visual scanning and motor tracking requiring focused attention. Subjects are required to sequentially connect numbered dots in ascending order that are randomly scattered on the screen in consecutive order. The total time in seconds to complete the array will be recorded as the score result. A lower score indicates better functioning.
Time frame
Baseline, 2, 4, 6, 12, 18, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baptist Health South Florida
Lead sponsor
Brainlab AG
Collaborator
Source ClinicalTrials.gov