Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation

NCT ID: NCT01701492

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-19
• Study Completion Date: 2018-01-23

Brief Summary

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.

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.

Conditions

Stem Cell Transplant During Childhood; Allogeneic Bone Marrow Transplant During Childhood

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stem Cell Transplant Survivors

All participants enrolled on this study will complete a questionnaire and undergo neurocognitive evaluation.

Questionnaire

Intervention Type: OTHER

A one-time assessment using both performance-based measures as well as both self- and parent-report questionnaires.

Neurocognitive Evaluation

Intervention Type: OTHER

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.

Questionnaire

Intervention Type: OTHER

A one-time assessment using both performance-based measures as well as both self- and parent-report questionnaires.

Neurocognitive Evaluation

Intervention Type: OTHER

A one-time neurocognitive evaluation conducted in the Psychology Clinic

Interventions

Questionnaire

A one-time assessment using both performance-based measures as well as both self- and parent-report questionnaires.

Intervention Type: OTHER

Neurocognitive Evaluation

A one-time neurocognitive evaluation conducted in the Psychology Clinic

Intervention Type: OTHER

Eligibility 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

• Age at least 8 years
• No known history of serious illness
• Demographic match to a St. Jude stem cell transplant patient

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.

• 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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Baldrick's Foundation

OTHER

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Phipps, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org

Clinical Trials Open at St. Jude

Other Identifiers

XPD12-077 BMTPE3

Identifier Type: -

Identifier Source: org_study_id