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

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ClinicalTrials.gov Identifier: NCT02783495
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
University of Tilburg
Information provided by (Responsible Party):
Jennie Taylor, University of California, San Francisco

Brief Summary:
This pilot clinical trial studies how well an iPad-based cognitive rehabilitation program works in improving quality of life in patients with grade II-III glioma. An iPad-based cognitive rehabilitation program may help to increase patients cognitive function and quality of life, and may provide doctors with valuable information for optimizing care of patients with brain tumors.

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 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device: iPad
Patients with brain tumors receive an iPad with the ReMind app. The patients will use the app to train neurocognitive and compensatory skills for 3 hours per week over the course of 12 weeks (36 hours in total)
Behavioral: Device: iPad
All patients will receive baseline neurocognitive and quality of life testing, followed by 3 months of the iPad-based intervention. At the end of the baseline visit, subjects will be lent an iPad to take home (or will be assisted in the installation of the ReMind app on their personal iPad) and instructed in the use of the ReMind app (and more basic iPad skills, if necessary). Subjects will review the intervention schedule (approximately 3 hours per week). Testing will be repeated 3 months after the baseline visit (i.e., immediately after the intervention) and 9 months after the baseline visit (i.e., 6 months after completion of the intervention), both time-points including a new MRI.




Primary Outcome Measures :
  1. Number of subjects who complete the intervention [ Time Frame: At 3 months after start of training ]
    Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).

  2. Patient-reported ease of use [ Time Frame: At 3 months after start of training ]
    Questionnaire based measure of ease of use as a measure of feasibility.

  3. Patient-reported user satisfaction [ Time Frame: At 3 months after start of training ]
    Questionnaire based measure of user satisfaction as a measure of feasibility.

  4. Change in attention [ Time Frame: At baseline, 3 months past training start, 9 months past training start ]
    Evaluation of visual attention on the NIH Toolbox Flanker Inhibitory Control and Attention Test. The attention score ranges from 0 to 10 (10 = best performance)

  5. Change in working memory [ Time Frame: At baseline, 3 months past training start, 9 months past training start ]
    Evaluation of working memory using the NIH Toolbox List Sorting Working Memory Test. Higher scores on each of these indicate higher levels of working memory.

  6. Quality of Life [ Time Frame: At baseline, 3 months past training start, 9 months past training start ]
    Measurement of general quality of life (QOL) using Functional Assessment of Cancer Therapy-Brain (FACT-Br), a multi-item questionnaire. Higher ratings suggest higher QOL.


Secondary Outcome Measures :
  1. Improvement on neurocognitive testing [ Time Frame: At baseline, 3 months past training start, 9 months past training start ]
    Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention.

  2. Subjective assessment of cognitive symptoms will be assessed [ Time Frame: At baseline, 3 months past training start, 9 months past training start ]
    Subjective assessment of cognitive symptoms using the Functional Assessment of Cancer Therapy: Cognitive Function (FACT-Cog) questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 ClinicalTrials.gov identifier (NCT number): NCT02783495


Contacts
Contact: Jennie W Taylor, MD, MPH 877-827-3222 clinicaltrials@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jennie W Taylor, MD, MPH    877-827-3222    clinicaltrials@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
University of Tilburg
Investigators
Principal Investigator: Jennie W Taylor, MD, MPH University of California, San Francisco

Responsible Party: Jennie Taylor, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02783495     History of Changes
Other Study ID Numbers: 16106
NCI-2017-01881 ( Registry Identifier: NCI Clinical Trials Reporting Program )
15-16366 ( Other Identifier: IRB Protocol Number )
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Jennie Taylor, 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