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Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients

This study is currently recruiting participants.
Verified June 2017 by Jennie Taylor, University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02783495
First Posted: May 26, 2016
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Tilburg
Information provided by (Responsible Party):
Jennie Taylor, University of California, San Francisco
May 22, 2016
May 26, 2016
June 27, 2017
May 2016
May 2018   (Final data collection date for primary outcome measure)
The percent of subjects who complete the intervention [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT02783495 on ClinicalTrials.gov Archive Site
  • Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention [ Time Frame: 2 years ]
  • Improvement on neurocognitive tests after the intervention and their associate with changes in quality of life, as measured by the FACT-BR questionnaire [ Time Frame: 2 years ]
  • Improvement on neurocognitive testing after the intervention [ Time Frame: 2 years ]
  • Improvement on neurocognitive tests after the intervention and their associate with changes in quality of life, as measured by the FACT-BR questionnaire [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioma
Behavioral: Device: iPad
All patients will receive baseline neurocognitive and quality of life testing, followed by 3 months of the iPad-based intervention, and 3 and 6 month follow-up neurocognitive and quality of life testing.
Experimental: Device: iPad
Intervention: Behavioral: Device: iPad
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2018
May 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jennie W Taylor, MD, MPH jennie.taylor@ucsf.edu
United States
 
 
NCT02783495
15-16366
No
Not Provided
Not Provided
Jennie Taylor, University of California, San Francisco
University of California, San Francisco
University of Tilburg
Not Provided
University of California, San Francisco
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP