Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant

NCT ID: NCT03355235

Last Updated: 2020-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-20

Study Completion Date

2019-08-27

Brief Summary

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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

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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

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Stem Cell Transplant Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cognitive assessment using standardized tools

cognitive assessment using standardized tools pre and post transplant.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cesar Rodriguez, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CCCWFU 02117

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00045767

Identifier Type: -

Identifier Source: org_study_id

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