Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas (NCT03948490) | Clinical Trial Compass
RecruitingNot Applicable
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
United States97 participantsStarted 2019-06-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<= 1 SD below normal on ≥ 2 or more domains of baseline neuropsychological assessments
Exclusion Criteria:
* Diagnosis or evidence of any of the following:
* • Glioblastoma
* • Extra-axial disease (i.e. meningioma)
* • Infra-tentorial disease
* Are not able to comply with study and/or follow-up procedures
* Are unable to complete or 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 low grade primary brain tumor and either be …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1)
Timeframe: 9 months
2
Number of participants who show a decline of >= 1.5 SD from baseline on the Wechsler Adult Intelligence Scale IV (WAIS-IV) Working Memory Score or Hopkins Verbal Learning Test (HVLT) (Arm 2)