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
|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)|
|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|
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.
- 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).
- 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.
- Patient-reported user satisfaction [ Time Frame: At 3 months after start of training ]Questionnaire based measure of user satisfaction as a measure of feasibility.
- 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)
- 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.
- 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.
- 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.
- 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
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
|Contact: Jennie W Taylor, MD, MPHfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Jennie W Taylor, MD, MPH 877-827-3222 email@example.com|
|Principal Investigator:||Jennie W Taylor, MD, MPH||University of California, San Francisco|