An observational study in Stem Cell Transplant Complications, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-31.
Sponsored by Wake Forest University Health Sciences · Observational
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.
4.2.1 Patients with multiple myeloma being considered for transplant and scheduled to undergo pre-transplant evaluation
Exclusion Criteria:
cognitive assessment using standardized tools pre and post transplant.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before to approximately 100 days after transplant
Changes in scores of the Montreal Cognitive Assessment (MoCA)
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.
Time frame: Before to approximately 100 days after transplant
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.
Time frame: Up 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
Plan to share: No
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences