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Completed

NCT Number: NCT03355235

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.

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Key information

Conditions

Stem Cell Transplant Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2017
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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