Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

NCT03355235 | Completed

• 2 other identifiers: IRB00045767CCCWFU 02117
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Agreement between cognitive test (PROMIS 8a and SAGE)

  Up to approximately 100 days after transplant

• Agreement between cognitive test (PROMIS 8a and MoCA)

  Up to approximately 100 days after transplant

• Agreement between cognitive test (SAGE and MoCA)

  Up to approximately 100 days after transplant

• Patients' preference between self-assessment tools Questionnaire

  Up to 1 year

Study Arms (1)

Cognitive assessment using standardized tools

cognitive assessment using standardized tools pre and post transplant.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Cesar Rodriguez, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 28, 2017
• Study Start: October 20, 2017
• Primary Completion: July 10, 2019
• Study Completion: August 27, 2019
• Last Updated: August 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)