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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU 02117 | Other Identifier | Wake Forest University Health Sciences |
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The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.
The overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, Self-Administered Gerocognitive Exam (SAGE) or the healthcare applied Montreal Cognitive Assessment (MoCA) assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive assessment using standardized tools | cognitive assessment using standardized tools pre and post transplant. |
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| Measure | Description | Time Frame |
|---|---|---|
| Scores of the PROMIS Cognitive Function, short form 8a | Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function, short form 8a. The mean scores (and standard deviations) for each time points will be presented. | Before to approximately 100 days after transplant |
| Scores of the Self-Administered Gerocognitive Exam (SAGE) | Will be assessed by the Self-Administered Gerocognitive Exam (SAGE). The mean scores (and standard deviations) for each time points will be presented. | Before to approximately 100 days after transplant |
| Scores of the Montreal Cognitive Assessment (MoCA) | Will be assessed by Montreal Cognitive Assessment (MoCA). The mean scores (and standard deviations) for each time points will be presented. | Before to approximately 100 days after transplant |
| Changes in scores of the PROMIS Cognitive Function, short form 8a | Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Function, short form 8a. The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred. | Before to approximately 100 days after transplant |
| Changes in scores of the Self-Administered Gerocognitive Exam (SAGE) | Will be assessed by the Self-Administered Gerocognitive Exam (SAGE). The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred. | Before to approximately 100 days after transplant |
| Changes in scores of the Montreal Cognitive Assessment (MoCA) |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between cognitive test (PROMIS 8a and SAGE) | Evaluate how each tests score is in agreement with the other using statistics correlations.examiner-implemented cognitive assessment, MoCA. Will assess the correlation of the tests before and post-transplant as well as the correlation of the change in scores. | Up to approximately 100 days after transplant |
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Inclusion Criteria:
Exclusion Criteria:
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4.2.1 Patients with multiple myeloma being considered for transplant and scheduled to undergo pre-transplant evaluation
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| Name | Affiliation | Role |
|---|---|---|
| Cesar Rodriguez, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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Will be assessed by Montreal Cognitive Assessment (MoCA). The mean changes in scores will be presented. The difference in each cognitive tests will be evaluated using a paired t-test to determine if any change has occurred. |
| Before to approximately 100 days after transplant |
| Agreement between cognitive test (PROMIS 8a and MoCA) | Evaluate how each tests score is in agreement with the other using statistics correlations. | Up to approximately 100 days after transplant |
| Agreement between cognitive test (SAGE and MoCA) | Evaluate how each tests score is in agreement with the other using statistics correlations. | Up to approximately 100 days after transplant |
| Patients' preference between self-assessment tools Questionnaire | Will assess the preference between SAGE and examiner-implemented, MoCA using the Assessment Preference questionnaire. Will present the frequency of preference. Will then test if the proportion is equal to 50% or if one of the assessments is significantly preferred over the other. | Up to 1 year |