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RECRUITING

NCT03948490

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-06-07

Completion Date

2026-03-31

Last Updated

2026-01-26

Healthy Volunteers

Conditions

Low-grade Glioma

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

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 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)

Locations (1)

University of California, San Francisco

San Francisco, California, United States