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Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355235
Recruitment Status : Active, not recruiting
First Posted : November 28, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : July 10, 2019
Estimated Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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



Primary Outcome Measures :
  1. Scores of the PROMIS Cognitive Function, short form 8a [ Time Frame: 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.

  2. Scores of the Self-Administered Gerocognitive Exam (SAGE) [ Time Frame: 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.

  3. Scores of the Montreal Cognitive Assessment (MoCA) [ Time Frame: 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.

  4. Changes in scores of the PROMIS Cognitive Function, short form 8a [ Time Frame: 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.

  5. Changes in scores of the Self-Administered Gerocognitive Exam (SAGE) [ Time Frame: 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.

  6. Changes in scores of the Montreal Cognitive Assessment (MoCA) [ Time Frame: 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 :
  1. Agreement between cognitive test (PROMIS 8a and SAGE) [ Time Frame: 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.

  2. Agreement between cognitive test (PROMIS 8a and MoCA) [ Time Frame: Up to approximately 100 days after transplant ]
    Evaluate how each tests score is in agreement with the other using statistics correlations.

  3. Agreement between cognitive test (SAGE and MoCA) [ Time Frame: Up to approximately 100 days after transplant ]
    Evaluate how each tests score is in agreement with the other using statistics correlations.

  4. Patients' preference between self-assessment tools Questionnaire [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355235


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Study Chair: Cesar Rodriguez, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03355235    
Other Study ID Numbers: IRB00045767
CCCWFU 02117 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No