Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

Completed

• Conditions: Stem Cell Transplant Complications

• Registration Number: NCT03355235
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-20
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-28
• Primary Completion: 2019-07-10
• Study Completion: 2019-08-27
• Status Verified: 2020-07
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with multiple myeloma
• Patients who will undergo pre-transplant evaluation with intentions to proceed to autologous stem cell transplant after stem cell collection.
• Patients willing and able to understand and sign an informed consent form
• Patients 18 yrs of age or older

Read More

Exclusion Criteria

• Patients with unstable psychiatric illness within the past 3 months of study enrollment.
• Patients who are considered unable to perform study evaluations at the investigator's discretion.
• Patients who are unable to read. (If patients require reading glasses, they must be worn at time of test.)
• Patients who do not proceed to stem cell transplant within 60 days of stem cell collection will be excluded from study.
• Patients who receive more than one cycle of chemotherapy between the time of stem cell collection and transplant will be excluded from study.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scores of the Self-Administered Gerocognitive Exam (SAGE)	Before to approximately 100 days after transplant	Will be assessed by the Self-Administered Gerocognitive Exam (SAGE). The mean scores (and standard deviations) for each time points will be presented.
Scores of the Montreal Cognitive Assessment (MoCA)	Before to approximately 100 days after transplant	Will be assessed by Montreal Cognitive Assessment (MoCA). The mean scores (and standard deviations) for each time points will be presented.
Changes in scores of the PROMIS Cognitive Function, short form 8a	Before to approximately 100 days after transplant	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.
Changes in scores of the Self-Administered Gerocognitive Exam (SAGE)	Before to approximately 100 days after transplant	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.
Scores of the PROMIS Cognitive Function, short form 8a	Before to approximately 100 days after transplant	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.
Changes in scores of the Montreal Cognitive Assessment (MoCA)	Before to approximately 100 days after transplant	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.

Secondary Outcome Measures

Name	Time	Method
Agreement between cognitive test (SAGE and MoCA)	Up to approximately 100 days after transplant	Evaluate how each tests score is in agreement with the other using statistics correlations.
Patients' preference between self-assessment tools Questionnaire	Up to 1 year	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.
Agreement between cognitive test (PROMIS 8a and SAGE)	Up to approximately 100 days after transplant	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.
Agreement between cognitive test (PROMIS 8a and MoCA)	Up to approximately 100 days after transplant	Evaluate how each tests score is in agreement with the other using statistics correlations.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States