Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

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 Overview

• Status: Completed
• Conditions: Stem Cell Transplant Complications

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

4.2.1 Patients with multiple myeloma being considered for transplant and scheduled to undergo pre-transplant evaluation

Description

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

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cognitive assessment using standardized tools; cognitive assessment using standardized tools pre and post transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Study Chair: Cesar Rodriguez, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): August 27, 2019

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00045767; CCCWFU 02117 (Other Identifier: Wake Forest University Health Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No