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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of California, San Francisco
Sponsor:
Collaborator:
Tilburg University, The Netherlands
Information provided by (Responsible Party):
Jennie Taylor, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02783495
First received: May 22, 2016
Last updated: May 25, 2016
Last verified: May 2016
  Purpose
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 Intervention
Glioma
Behavioral: Device: iPad

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: May 2016
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02783495

Contacts
Contact: Jennie W Taylor, MD, MPH jennie.taylor@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jennie W Taylor, MD, MPH       jennie.taylor@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Tilburg University, The Netherlands
  More Information

Responsible Party: Jennie Taylor, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02783495     History of Changes
Other Study ID Numbers: 15-16366
Study First Received: May 22, 2016
Last Updated: May 25, 2016

Keywords provided by University of California, San Francisco:
glioma
neurocognitive
quality of life

Additional relevant MeSH terms:
Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
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

ClinicalTrials.gov processed this record on April 24, 2017