Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

Stem Cell Transplant Complications Clinical Trial

Official title:

Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355235
• Other study ID #: IRB00045767
• Secondary ID: CCCWFU 02117
• Status: Completed
• Start date: October 20, 2017
• Est. completion date: August 27, 2019

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 27, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stem Cell Transplant Complications

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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