Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas

NCT03948490 | Recruiting FDA Device

• 2 other identifiers: 19103NCI-2019-03245
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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

Keywords

cognitive impairment; quality of life

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects who complete all of the intervention exercises for each cohort (Arm 1)

  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

  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)

  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

  3 years

Secondary Outcomes (6)

• Improvement of ≥1.5 SD in at least one cognitive domain at post-intervention and/or follow-up for each Cohort (Arm 1)

  9 months

• Improvement of ≥1.5 SD in health related quality of life (HRQOL) as measured by Patient-Reported Outcomes Measurement Information System (PROMIS-NeuroQOL) at post-intervention and/or follow-up for each Cohort (Arm 1)

  9 months

• Assess relation ships between cognitive changes and clinical factors (Arm 2)

  3 years

• Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (Arm 2)

  3 years

• Correlation of PROMIS-NeuroQOL scores and cognitive changes (Arm 2)

  3 years

Study Arms (6)

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

OTHER

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

Behavioral: In-person cognitive rehabilitation

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

EXPERIMENTAL

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

Device: ReMind iPad app

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

EXPERIMENTAL

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

Device: Healthy SMS texting

Arm 2 Cohort 4: Longitudinal arm/Upfront radiation

NO INTERVENTION

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

Arm 1 Cohort 5: Longitudinal arm/No upfront radiation

NO INTERVENTION

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

Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation

OTHER

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

Behavioral: Telehealth cognitive rehabilitation

Interventions

ReMind iPad app DEVICE

Evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors.

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

Healthy SMS texting DEVICE

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.

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

In-person cognitive rehabilitation BEHAVIORAL

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.

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

Telehealth cognitive rehabilitation BEHAVIORAL

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

Arm 1 Cohort 1A: Telehealth Cognitive Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tilburg University: collaborator
• University of California, Berkeley: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jennie Taylor, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennie Taylor, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 14, 2019
• Study Start: June 7, 2019
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)