- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01701492
Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation
This is an observational study to collect information by use of performance-based measures and survey questionnaires. It does not include interventions aimed at altering patient outcome.
Advances in pediatric hematopoietic stem cell transplantation (SCT) have resulted in improved survival and prompted increased attention to the potential adverse late effects of this procedure. Survivors of SCT are thought to be at risk for neurocognitive deficits as a result of their exposure to a number of potentially neurotoxic agents. Prior studies done by our group and others have demonstrated generally stable cognitive function in the first 5 years following transplant, with little evidence of significant declines. However, there has been almost no research to date on the status of very long-term (> 5 years post-transplant) survivors. In this study, we will evaluate a large sample of long-term survivors of allogeneic SCT using measures of intelligence, academic achievement, and specific cognitive functions such as attention, working memory and processing speed. We will also obtain measures of behavioral functioning and quality of life. We will examine how this group of survivors are functioning relative to normative expectations, and in comparison to community controls without a history of serious illness, matched on age, gender, race/ethnicity, and socioeconomic status. We will also examine the relationship between cognitive function and psychosocial function and quality of life in this population.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will involve a one-time assessment using both performance based measures as well as both self- and parent-report questionnaires. During their yearly visit to St. Jude, eligible patients who agree to participate will undergo a single neurocognitive evaluation. This evaluation will take place in the Psychology Clinic. The administration time for the assessment battery is estimated at 2.5-3.5 hours, with variability depending on the age of the patient and the speed of completion of the tasks. All measures selected for the study have well-established psychometric properties, including acceptable reliability and validity. All measures were standardized on large, representative samples of children and adults and have age-specific norms.
PRIMARY OBJECTIVE:
To examine and describe psychological outcomes in long-term (> 5 years) survivors of allogeneic bone marrow or stem cell transplantation (SCT) in childhood. This will be conducted in a one-time cross-sectional assessment using both performance based measures and survey questionnaires. Comparisons will be made to established normative data on well validated standardized instruments and to control participants in the community without a history of serious illness, matched on age, gender, race/ethnicity and socioeconomic status.
- To describe global cognitive and academic outcomes in this SCT cohort using measures of intelligence and academic achievement.
- To examine performance in specific neuropsychologic domains, including working memory, processing speed and other executive functions.
- To examine psychosocial function and quality of life among long-term SCT survivors using both self- and parent-report.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Treated with allogeneic bone marrow or stem cell transplant at St. Jude Children's Research Hospital (SJCRH)
- ≤ 21 years at time of transplant
- > 5 years from date of last transplant
- Currently at least 8 years of age
- English as primary language
Exclusion Criteria:
- Transplanted for metabolic storage disorder, osteogenesis imperfecta, osteopetrosis, or dyskeratosis congenita.
- History of central nervous system (CNS) injury/disease predating or unrelated to reason for SCT
- Major sensory or motor impairment that would preclude valid cognitive assessment. However, we will not exclude participants with mild cognitive impairments or special educational needs.
- Prior participation in BMTPE protocol at St. Jude Children's Research Hospital.
Control Group Inclusion Criteria
- Age at least 8 years
- No known history of serious illness
- Demographic match to a St. Jude stem cell transplant patient
Control Group Exclusion Criteria
- Major sensory or motor impairment that would preclude valid cognitive assessment.
- History of specific CNS disease/injury (e.g., Down Syndrome, traumatic brain injury). However, we will not exclude participants with mild cognitive impairments or special educational needs.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stem Cell Transplant Survivors
All participants enrolled on this study will complete a questionnaire and undergo neurocognitive evaluation.
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A one-time assessment using both performance-based measures as well as both self- and parent-report questionnaires.
A one-time neurocognitive evaluation conducted in the Psychology Clinic
|
Normal control participants
Control participants in the community without a history of serious illness, matched on age, gender, race/ethnicity and socioeconomic status.
They will complete a questionnaire and undergo neurocognitive evaluation.
|
A one-time assessment using both performance-based measures as well as both self- and parent-report questionnaires.
A one-time neurocognitive evaluation conducted in the Psychology Clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intelligence and academic achievement
Time Frame: 1 day
|
To describe global cognitive and academic outcomes in this SCT cohort using measures of intelligence and academic achievement when compared to established normative data on well validated standardized instruments as well as to control participants in the community.
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1 day
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Performance in specific neuropsychologic domains.
Time Frame: 1 day
|
To examine performance in specific neuropsychologic domains, including working memory, processing speed and other executive functions compared to established normative data on well validated standardized instruments as well as to control participants in the community.
|
1 day
|
Psychosocial function
Time Frame: 1 day
|
To examine psychosocial function among long-term SCT survivors using both self- and parent-report compared to established normative data on well validated standardized instruments as well as to control participants in the community.
|
1 day
|
Quality of life
Time Frame: 1 day
|
To examine quality of life among long-term SCT survivors using both self- and parent-report compared to established normative data on well validated standardized instruments as well as to control participants in the community.
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sean Phipps, PhD, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XPD12-077 BMTPE3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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