Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion
Jennie Taylor, MD, MPH(ucsf)

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. Determine the feasibility of standard and innovative cognitive rehabilitation in lower grade gliomas (LrGG) patients. Feasibility will be the percentage of subjects who complete all of the intervention exercises. The intervention will be considered feasible for a larger-scale efficacy study if greater than 80% of the subjects complete the intervention. Cognitive and HRQOL will be assessed pre-intervention and compared to post-intervention (3 months from baseline) and 6-month (9 months from baseline) follow-up. Changes in cognition and HRQOL will be correlated with serial imaging at pre-intervention compared to short and intermediate-term follow-up e.g. in T2 tumor volume, Diffusion tensor imaging (DTI) scalar quantification, resting-state Functional magnetic resonance imaging (fMRI) connectivity. Participants will first be offered the in-person cognitive rehabilitation option (Cohort 1). If they are unable to participate because of logistic challenges, they will randomly be assigned to the iPad based intervention (Cohort 2), or automated texting program (Cohort 3). Participants will complete standardized cognitive testing and quality of life assessments at baseline, immediately post intervention and 6 months after intervention. 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. Predict optimal time for cognitive rehabilitation to abrogate tumor and treatment-related effects on cognition and HRQOL in adult LrGG. Enroll 100 newly diagnosed patients with a goal of enrolling 50 who will receive radiation treatment after surgery (Cohort 4) and 50 who will not receive radiation after surgery (Cohort 5). Patients in both groups 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.

Keywords

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

Eligibility

For people ages 18 years and up

Arm 1:

Inclusion Criteria:

  • Histologically confirmed WHO grade 2 or 3 gliomas
  • ≥ 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:

  • 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

Arm 2:

Inclusion Criteria:

  • Have a presumed world health organization (WHO) grade 2 or 3 gliomas and be undergoing definitive surgery at UCSF
  • ≥ 18 years old
  • Karnofsky performance status (KPS) of ≥ 70 (Appendix 6)
  • 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:

  • Are not able to comply with study and/or follow-up procedures
  • 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

Location

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

Lead Scientist

  • Jennie Taylor, MD, MPH (ucsf)
    Assistant Professor, Neurology. Authored (or co-authored) 14 research publications

Details

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