Clinical trial NCT03355235: Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
Official title: Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplant Complications
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Scores of the PROMIS Cognitive Function, short form 8a
timeFrame: Before to approximately 100 days after transplant
measure: Scores of the Self-Administered Gerocognitive Exam (SAGE)
timeFrame: Before to approximately 100 days after transplant
measure: Scores of the Montreal Cognitive Assessment (MoCA)
timeFrame: Before to approximately 100 days after transplant
measure: Changes in scores of the PROMIS Cognitive Function, short form 8a
timeFrame: Before to approximately 100 days after transplant
measure: Changes in scores of the Self-Administered Gerocognitive Exam (SAGE)
timeFrame: Before to approximately 100 days after transplant
measure: Changes in scores of the Montreal Cognitive Assessment (MoCA)
timeFrame: Before to approximately 100 days after transplant
Secondary outcomes:
measure: Agreement between cognitive test (PROMIS 8a and SAGE)
timeFrame: Up to approximately 100 days after transplant
measure: Agreement between cognitive test (PROMIS 8a and MoCA)
timeFrame: Up to approximately 100 days after transplant
measure: Agreement between cognitive test (SAGE and MoCA)
timeFrame: Up to approximately 100 days after transplant
measure: Patients' preference between self-assessment tools Questionnaire
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Cesar Rodriguez, MD
role: STUDY_CHAIR
References: