NCT03948490 · University of California, San Francisco
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
ReMind iPad app
Evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors.
DEVICE
Healthy SMS texting
Participants receive a daily message sent at a random time (within their chosen timeframe(s); e.g. 9am-9pm). Messages will focus on patient-based education-focused health-related quality of life and cognitive education such as internal and external cognitive compensatory strategy training, fatigue management, and coping skills.
BEHAVIORAL
In-person cognitive rehabilitation
The in-person cognitive rehabilitation will focus on the application of evidenced based strategies recommended as practice guidelines by the American Congress of Rehabilitation Medicine Cognitive Rehabilitation Task Force (ACRM-CR). The treatment occurs in two stages 1) comprehensive neuropsychological assessment and rehabilitation planning and 2) implementation of treatment planning.
BEHAVIORAL
Telehealth cognitive rehabilitation
The telehealth cognitive rehabilitation will take place over secure UCSF Zoom. It will focus on the application of evidenced based strategies recommended as practice guidelines by the American Congress of Rehabilitation Medicine Cognitive Rehabilitation Task Force (ACRM-CR). The treatment occurs in two stages 1) comprehensive neuropsychological assessment and rehabilitation planning and 2) implementation of treatment planning
Primary outcome measures
Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1)
Time frame: 9 months
The intervention will be considered feasible for a larger-scale efficacy study if greater than 80% of the subjects complete the intervention. Patients will be replaced if they drop out of the intervention (either by declining their first follow-up visit for Cohort 1 in-person rehab; declining to participate in the Cohort 2 ReMind intervention; or by texting the word "STOP" in the Cohort 3 short message service (SMS) texting intervention)) within the first 14 days. These patients will be replaced. All other patients will be evaluable for feasibility if they remain in the Cohort past the first 14 days of the intervention
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)
Time frame: 3 years
Detect a decline of greater than 1.5 standard deviation (SD) compared to baseline on WAIS-IV Working Memory Score or HVLT during the 36 month follow-up after surgery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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:
- • Glioblastoma
- • 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)
Where
- San Francisco, California
Collaborators
Tilburg University, University of California, Berkeley
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations