Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
Jennie Taylor, MD, MPH

Description

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.

Details

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.

Keywords

Low-grade Glioma cognitive impairment quality of life Glioma ReMind iPad app Healthy SMS texting In-person cognitive rehabilitation Telehealth cognitive rehabilitation

Eligibility

For people ages 18 years and up

Arm 1:

Inclusion Criteria:

  • Histologically confirmed low grade supratentorial primary brain tumor
  • >= 18 years old
  • Life expectancy > 12 weeks
  • Karnofsky performance status (KPS) ≥ 70 (Appendix 6)
  • 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 ≥ 6 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
  • Have acute psychiatric issues (suicidality, active psychosis, 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 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)

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03948490
Study Type
Interventional
Last Updated