Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation
Data Collection
+ other Data
+ other Data
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 19, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.133 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 8 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
St. Jude Children's Research Hospital
Memphis, United StatesOpen St. Jude Children's Research Hospital in Google Maps