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

Primary Purpose

Glioma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device: iPad
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring glioma, neurocognitive, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device: iPad

Arm Description

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)

Outcomes

Primary Outcome Measures

Number of subjects who complete the intervention
Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).
Patient-reported ease of use
Questionnaire based measure of ease of use as a measure of feasibility.
Patient-reported user satisfaction
Questionnaire based measure of user satisfaction as a measure of feasibility.
Change in attention
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)
Change in working memory
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.
Change in Quality of Life
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

Improvement on neurocognitive testing
Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention.
Subjective assessment of cognitive symptoms will be assessed
Subjective assessment of cognitive symptoms using the Functional Assessment of Cancer Therapy: Cognitive Function (FACT-Cog) questionnaire

Full Information

First Posted
May 22, 2016
Last Updated
January 14, 2020
Sponsor
University of California, San Francisco
Collaborators
Tilburg University
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1. Study Identification

Unique Protocol Identification Number
NCT02783495
Brief Title
Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
Official Title
Feasibility And Efficacy Of An iPad-Based Cognitive Rehabilitation Program In Brain Tumor Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding
Study Start Date
July 19, 2016 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Tilburg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
glioma, neurocognitive, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: iPad
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Device: iPad
Intervention Description
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 Measure Information:
Title
Number of subjects who complete the intervention
Description
Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).
Time Frame
At 3 months after start of training
Title
Patient-reported ease of use
Description
Questionnaire based measure of ease of use as a measure of feasibility.
Time Frame
At 3 months after start of training
Title
Patient-reported user satisfaction
Description
Questionnaire based measure of user satisfaction as a measure of feasibility.
Time Frame
At 3 months after start of training
Title
Change in attention
Description
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)
Time Frame
At baseline, 3 months past training start, 9 months past training start
Title
Change in working memory
Description
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.
Time Frame
At baseline, 3 months past training start, 9 months past training start
Title
Change in Quality of Life
Description
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.
Time Frame
At baseline, 3 months past training start, 9 months past training start
Secondary Outcome Measure Information:
Title
Improvement on neurocognitive testing
Description
Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention.
Time Frame
At baseline, 3 months past training start, 9 months past training start
Title
Subjective assessment of cognitive symptoms will be assessed
Description
Subjective assessment of cognitive symptoms using the Functional Assessment of Cancer Therapy: Cognitive Function (FACT-Cog) questionnaire
Time Frame
At baseline, 3 months past training start, 9 months past training start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennie W Taylor, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Subject data collected or generated as the result of participation in this study may be shared with co-investigators at the Tilburg University, The Netherlands, who developed the ReMind application. This may include clinical data, pathology data, imaging data, image files, and neurocognitive assessment results. All such data will be identified only by the subject's study code. All clinical research staff from The Netherlands will maintain all study materials in compliance with applicable laws, regulations and policies.
IPD Sharing Time Frame
July 2016- May 2019

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

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