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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01881 | Registry Identifier | NCI Clinical Trials Reporting Program |
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Funding
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| Name | Class |
|---|---|
| Tilburg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: iPad | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: iPad | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennie W Taylor, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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.
July 2016- May 2019
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |