Stem Cell Transplant ComplicationsNCT03355235
Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
An observational study of Stem Cell Transplant Complications, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant Complications
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 27 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 4.2.1 Patients with multiple myeloma being considered for transplant and scheduled to undergo pre-transplant evaluation
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
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.
Read the 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.
- Conditions
- Stem Cell Transplant Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive assessment using standardized tools | cognitive assessment using standardized tools pre and post transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before to approximately 100 days after transplant
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.
Measured: Before to approximately 100 days after transplant
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.
Measured: Before to approximately 100 days after transplant
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.
Measured: Before to approximately 100 days after transplant
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.
Measured: Before to approximately 100 days after transplant
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.
Measured: Before to approximately 100 days after transplant
Secondary outcomes (4)
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.
Measured: Up to approximately 100 days after transplant
Agreement between cognitive test (PROMIS 8a and MoCA)
Evaluate how each tests score is in agreement with the other using statistics correlations.
Measured: Up to approximately 100 days after transplant
Agreement between cognitive test (SAGE and MoCA)
Evaluate how each tests score is in agreement with the other using statistics correlations.
Measured: Up to approximately 100 days after transplant
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start20 Oct 2017
- Primary completion10 Jul 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesar Rodriguez, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355235
- Sponsor's protocol ID
- IRB00045767
- Other IDs
- CCCWFU 02117
- Status last verified
- Jul 2020
- First submitted
- 20 Oct 2017
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brilliant Study: Assessing Cognition in Myeloma Patients Undergoing Transplant
- ClinicalTrials.gov ID
- NCT03355235
- Acronym / sponsor ID
- IRB00045767
- Conditions
- Stem Cell Transplant Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive assessment using standardized tools | – | –cognitive assessment using standardized tools pre and post transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 4.2.1 Patients with multiple myeloma being considered for transplant and scheduled to undergo pre-transplant evaluation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Agreement between cognitive test (PROMIS 8a and SAGE)
Time frame: Up to approximately 100 days after transplant
Agreement between cognitive test (PROMIS 8a and MoCA)
Time frame: Up to approximately 100 days after transplant
Agreement between cognitive test (SAGE and MoCA)
Time frame: Up to approximately 100 days after transplant
Patients' preference between self-assessment tools Questionnaire
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar Rodriguez, MD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant Complications, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of the PROMIS Cognitive Function, short form 8a (time frame: Before to approximately 100 days after transplant). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.