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Recruiting
NCT03948490
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
Conditions: Low-grade Glioma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 117
Sponsor: University of California, San Francisco
Location: University of California, San Francisco San Francisco California
Summary
Patients with glial brain tumors have increasingly improved outcomes, with median survival of 5-15 years. However, the treatments, including surgery, radiation, and chemotherapy, often lead to impaired attention, working memory, and other cognitive functions. These cognitive deficits frequently have significant impact on patient quality of life. Although currently, there is no established standard of care to treat cognitive deficits in brain tumor patients, standard cognitive rehabilitative treatments have been developed for those with traumatic brain injury and stroke. However, the feasibility and efficacy of these cognitive treatments in individuals with brain tumors remains unclear.
Eligibility Criteria
Arm 1:
Inclusion Criteria:
* Histologically confirmed low grade supratentorial primary brain tumor
* \>= 18 years old
* Life expectancy \> 12 weeks
* Karnofsky performance status (KPS) \>= 70
* Must speak and be able to read English fluently
* Must have access to the internet
* Must have text enabled cellphone
* Must be receiving MRI scans at University of California, San Francisco (UCSF)
* Must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 3 months
* Must be \>= 6 months from craniotomy
* Must have subjective complaints of cognitive deficits
* Must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics
* Must score \= 3 cognitive tests at baseline, which is indicative that patients would be unable to complete the cognitive rehabilitation interventions
* Are acutely suicidal, psychotic, and/or gravely disabled.
* Patients who, based on the neuropsychologist's opinion, are unable to participate in cognitive testing and/or cognitive rehab secondary to significant neurologic deficit
Arm 2:
Inclusion Criteria:
* Have a presumed lower grade IDH-mutated primary brain tumor and either be undergoing definitive surgery or have had surgical resection within the last 4 months.
* Prior surgery is allowed if they have not received additional tumor directed treatment.
* \>= 18 years old
* Must speak and be able to read English fluently.
* Plan to continue to care in neuro-oncology at UCSF
* Must be receiving MRI scans.
Exclusion Criteria:
* Diagnosis or evidence of any of the following:
* • Primary brain tumor classified as CNS WHO Grade 4
* • Extra-axial disease (i.e. meningioma)
* Are not able to comply with study and/or follow-up procedures
* Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)
Source: ClinicalTrials.gov (NCT03948490). StuddyBuddy aggregates publicly available trial information.