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

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. Identifier: NCT02783495
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : June 27, 2017
University of Tilburg
Information provided by (Responsible Party):
Jennie Taylor, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Glioma Behavioral: Device: iPad Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Device: iPad 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.

Primary Outcome Measures :
  1. The percent of subjects who complete the intervention [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention [ Time Frame: 2 years ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02783495

Contact: Jennie W Taylor, MD, MPH

United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jennie W Taylor, MD, MPH   
Sponsors and Collaborators
University of California, San Francisco
University of Tilburg

Responsible Party: Jennie Taylor, Assistant Professor, University of California, San Francisco Identifier: NCT02783495     History of Changes
Other Study ID Numbers: 15-16366
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Jennie Taylor, University of California, San Francisco:
quality of life

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases