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

Study Overview
=================
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.

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

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Behavioral: Device: iPad


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: iPad<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glioma, neurocognitive, quality of life