Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation
Completed
Conditions studied: Stem Cell Transplant During Childhood, Allogeneic Bone Marrow Transplant During Childhood
In brief
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.
Key facts
- Study ID
- NCT01701492
- Run by
- St. Jude Children's Research Hospital
- People needed
- 133
- Starts
- 2012-10-19
- Expected to finish
- 2018-01-23
- Last updated by the study team
- 2018-05-18
Who can join
Age: 8 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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