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

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.

Study Overview

• Status: Terminated
• Conditions: Glioma
• Intervention / Treatment: Behavioral: Device: iPad

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who complete the intervention	Subjects who complete all of the intervention exercises (approximately 36 hours of intervention).	At 3 months after start of training
Patient-reported ease of use	Questionnaire based measure of ease of use as a measure of feasibility.	At 3 months after start of training
Patient-reported user satisfaction	Questionnaire based measure of user satisfaction as a measure of feasibility.	At 3 months after start of training
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)	At baseline, 3 months past training start, 9 months past training start
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.	At baseline, 3 months past training start, 9 months past training start
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.	At baseline, 3 months past training start, 9 months past training start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement on neurocognitive testing	Improvement on neurocognitive testing as measured by the NIH Toolbox assessment after the intervention.	At baseline, 3 months past training start, 9 months past training start
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	At baseline, 3 months past training start, 9 months past training start

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Tilburg University
• Investigators: Principal Investigator: Jennie W Taylor, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2016
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: May 22, 2016
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; glioma; neurocognitive
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioma; Brain Neoplasms
• Other Study ID Numbers: 16106; NCI-2017-01881 (Registry Identifier: NCI Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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