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Eligibility
for people ages 18 years and up
Location
at San Francisco, California
Dates
study started
Principal Investigator

Description

Summary

This pilot trial of this iPad-based intervention in glioma patients at University of California, San Francisco (UCSF) will establish feasibility and preliminary efficacy data to support a funding application for a larger clinical trial. Twenty patients with stable low-grade gliomas will complete a computerized battery of standardized neurocognitive tests and quality of life assessments at baseline. Subjects will complete the intervention at home over 3 months. Neuro-cognitive testing will be repeated 3 and 9 months after baseline. Subjects will also complete a post-intervention questionnaire on the usefulness, attractiveness, difficulty and burden of the intervention. Clinical data will be collected at the time of each assessment. This will include diagnostic and treatment history, magnetic resonance imaging (MRI data), tumor genomics and immunohistochemistry.

Keywords

Glioma neurocognitive quality of life

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients must have histologically confirmed WHO grade 2 or 3 gliomas.
  • Patients must be> 18 years old
  • Patients must have a life expectancy> 12 weeks.
  • Patients must have a Karnofsky performance status of> 70.
  • This study was designed to include women and minorities, but was not designed to measure differences between them. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race.
  • Patients must speak and be able to read English fluently.
  • All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information.
  • Patients may not be known to be HIV-positive. HIV testing is not required for study participation.
  • Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
  • Patients must be receiving MRI scans at UCSF
  • Patients must be clinically stable and off treatment (e.g. radiation or chemotherapy)for ≥ 6 months
  • Patients must be ≥ 6 months from craniotomy
  • Patients must have subjective complaints of cognitive deficits.
  • Patients must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics

You CAN'T join if...

  • Patients who are not able to comply with study and/or follow-up procedures.
  • Patients who do not have home access to the Internet.
  • Patients who, based on the physician's opinion, are unable to participate in neurocognitive testing and/or neurocognitive rehab secondary to significant neurologic deficit

Location

Details

Status
accepting new patients
Start Date
Sponsor
University of California, San Francisco
ID
NCT02783495
Lead Scientist
Jennie Taylor
Study Type
Interventional
Last Updated
May 2016
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