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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    180
  • sponsor
    University of California, San Francisco
Updated on 23 August 2021
stroke
karnofsky performance status
MRI Scan
seizure
brain tumor

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.

Description

This trial studies how well cognitive rehabilitation therapy works in improving cognitive function in patients with lower grade gliomas. Patients with low grade gliomas frequently have symptoms of cognitive impairment, such as difficulty with short term memory and processing information, that impacts their daily lives. The ReMind application (app) is an iPad app developed for cognitive rehabilitation for patients. The healthy texting platform was developed to help patients with depression and cognitive difficulty to provide education and track their mood. Methods of cognitive rehabilitation therapy such as in person cognitive rehabilitation, computerized cognitive rehabilitation, and healthy text messaging may help improve cognition and quality of life in patient with low grade gliomas.

PRIMARY OBJECTIVES:

  • Assess feasibility of each interventional arm independently (Arm 1)
  • Detect a decline of >= 1.5 standard deviation (SD) from baseline on the Wechsler Adult Intelligence Scale (WAIS)- IV Working Memory Score or Hopkins Verbal Learning Test (HVLT) during the 36 month follow-up after surgery. (Arm 2)

SECONDARY OBJECTIVES:

  • Measure changes in cognition at post-intervention and follow-up for each cohort - cohort 1 in-person; cohort 1A telehealth; cohort 2 ReMind; and cohort 3 short message service (SMS) texting - at 3 months and 6 months post-intervention. (Arm 1)
  • Measure changes in health related quality of life (HRQOL) at post-intervention and follow-up for each cohort - cohort 1 in-person; cohort 2 ReMind; and cohort 3 SMS texting - as captured by Patient Reported Outcomes Measurement Information System-quality of life (PROMIS-QOL) - at 3 months and 6 months post-intervention. (Arm 1)
  • Assess relationships between cognitive changes and clinical factors (molecular subtype, age, tumor location, treatment, and radiation fields when appropriate). (Arm 2)
  • Assess relationships between cognitive changes and serial magnetic resonance (MR) imaging (T2 and contrast-enhancing tumor volume, diffusion tensor imaging (DTI) scalar quantification, structural connectivity, resting-state functional magnetic resonance imaging (fMRI) connectivity). (Arm 2)
  • Assess relationships between HRQOL and cognitive changes. (Arm 2)

EXPLORATORY OBJECTIVES:

  • Assess relationships between cognitive and HRQOL. (Arm 1)
  • Assess relationships between cognitive changes and clinical factors (molecular subtype, age, tumor location, and radiation fields when appropriate). (Arm 1)
  • Assess relationships between HRQOL changes and clinical factors (molecular subtype, age, tumor location, and radiation fields when appropriate). (Arm 1)
  • Assess relationships between cognitive changes and serial MR imaging (T2 and contrast-enhancing tumor volume, DTI scalar quantification, structural connectivity, resting-state fMRI connectivity). (Arm 1)
  • Identify predictive power of tumor characteristics (tumor volume, location, molecular characteristics), patient characteristics (extent of resection, treatment, and radiation fields when appropriate), imaging characteristics (e.g. fMRI, DTI changes), and decline in cognition or HRQOL. (Arm 2)
    OUTLINE

Patients are invited to participant in Cohort 1A. Patients unable to participant in Cohort 1A are randomized to Cohort 2 or Cohort 3.

ARM 1:

  • COHORT 1 (CLOSED): Patients receive standard in-person cognitive rehabilitation sessions with a neuropsychologist every 2 weeks over 1 hour each for 12 weeks.
  • COHORT 1A: Patients receive telehealth cognitive rehabilitation with University of California, San Francisco (UCSF) Zoom visits with a neuropsychologist who specializes in brain tumors over 60 minutes every 2 weeks for 3 months.
  • COHORT 2: Patients receive computerized cognitive rehabilitation using the ReMind app over 3 hours per week for 12 weeks.
  • COHORT 3: Patients receive healthy text messages daily at random points during the week (Monday - Friday) for 12 weeks.

ARM 2:

  • COHORT 4: Patients who receive radiation after surgery, undergo longitudinal cognitive and health related quality of life assessments prior to surgery, prior to start of radiation, at 4-6 week after radiation, 6 and 12 months after surgery, and then every 6 months for 36 months after surgery.
  • COHORT 5: Patients who do not receive radiation after surgery, undergo longitudinal cognitive and health related quality of life assessments prior to surgery, within 1 month after surgery, 2-4 months after surgery, 6 and 12 months after surgery, and then every 6 months for 36 months after surgery.

After completion of study, patients in cohorts 1-3 are followed up at 3 and 9 months.

Details
Condition Low Grade Glioma
Treatment ReMind iPad app, Healthy SMS texting, In-person cognitive rehabilitation, Telehealth cognitive rehabilitation
Clinical Study IdentifierNCT03948490
SponsorUniversity of California, San Francisco
Last Modified on23 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a presumed low grade supratentorial primary brain tumor and be undergoing definitive surgery at UCSF
>= 18 years old
Must speak and be able to read English fluently
Prior biopsy is eligible if they have not received additional systemic treatment or radiation and definitive surgery is occurring with 1 year of biopsy
Plan to continue to care in neuro-oncology at UCSF
Must be receiving MRI scans at UCSF

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
Have acute psychiatric issues (suicidality, active psychosis, gravely disabled)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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