Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT03948490

Conditions

Low-grade Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ReMind iPad app

Healthy SMS texting

In-person cognitive rehabilitation

Telehealth cognitive rehabilitation

Study Details

Brief 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.

Conditions

Low-grade Glioma

Study ID

NCT03948490

Start date

Jun 7, 2019

Status verified date

Jul, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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)

Study Design

Enrollment

117 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Arm 1 Cohort 1: Interventional arm/In-person rehab (CLOSED)

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.

n = 20 patients

experimental: Arm 1 Cohort 2: Interventional arm/ReMind iPad app (CLOSED)

The ReMind iPad-based cognitive rehabilitation was developed with collaborators at Tilburg University, The Netherlands, and is an evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors. Brain plasticity-based computerized cognitive training is a newly developing field of therapeutics for neurological and psychiatric disorders that uses frequent game-like training sessions to drive improvements in cognitive functions.

n = 20 patients

experimental: Arm 1 Cohort 3: Interventional arm/Healthy SMS texting (CLOSED)

The mobile phone texting intervention was developed with collaborators at Zuckerberg San Francisco General Hospital and is currently being studied in individuals with depression and traumatic brain injury. 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.

n = 20 patients

no intervention: Arm 2 Cohort 4: Longitudinal arm/Upfront radiation

Patients will undergo longitudinal global cognitive and HRQOL assessments at baseline prior to surgery, after surgery, 3 months after surgery and every 6 months for 3 years. Clinical data will be collected at the time of each assessment. This will include changes in serial imaging e.g. in T2 tumor volume, DTI scalar quantification, resting-state fMRI connectivity n = 50 patients

no intervention: Arm 2 Cohort 5: Longitudinal arm/No upfront radiation

Patients will undergo longitudinal global cognitive and HRQOL assessments at baseline prior to surgery, after surgery, 3 months after surgery and every 6 months for 3 years. Clinical data will be collected at the time of each assessment. This will include changes in serial imaging e.g. in T2 tumor volume, DTI scalar quantification, resting-state fMRI connectivity n = 50 patients

other: Arm 1 Cohort 1A: 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. During treatment implementation, patients acquire, apply, and adapt evidenced based strategies based on neuropsychological testing and conjointly developed treatment planning goals.

N=20

Interventions

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.

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.

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.

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 measure

  • Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1) [ Time Frame: 9 months ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jennie Taylor, MD, MPH

415-353-2966jennie.taylor@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Jennie W Taylor, MD, MPH

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Jennie W Taylor, MD, MPH

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • cognitive impairment
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-14.