Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors
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| ClinicalTrials.gov Identifier: NCT01014195 |
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Recruitment Status :
Completed
First Posted : November 16, 2009
Last Update Posted : June 7, 2016
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- This study will evaluate the association between changes in basic cognitive and behavioral functioning by the end of chemotherapy treatment, and the later development of higher order executive functions in pediatric acute lymphoblastic leukemia (ALL).
- The association between acute treatment-related changes in brain integrity and subsequent brain maturation in long-term survivors of pediatric ALL will be evaluated.
- The association between patterns of behavioral and executive dysfunction and brain maturation in long-term survivors of pediatric ALL will be examined.
- The association between genetic polymorphisms in key enzyme pathways and higher order brain development in long-term survivors of pediatric ALL will be explored.
- The associations between biologic and behavioral indices of fatigue/sleep and higher order brain development in long-term survivors of pediatric ALL will be explored.
| Condition or disease | Intervention/treatment |
|---|---|
| Neurocognitive Impairment Acute Lymphoblastic Leukemia | Other: Neurocognitive and behavioral evaluation |
Survival rates for pediatric acute lymphoblastic leukemia (ALL) now exceed 80%. With this growing population of long-term survivors comes recognition that a considerable proportion experience one or more significant late effects. For children undergoing central nervous system (CNS) treatment, common late effects include neurocognitive impairment and neurobehavioral problems. Although these problems first manifest as subtle difficulties with attention and processing speed, they can evolve into deficits in higher order brain functions that significantly impact functional skills in a subset of long-term survivors. There currently is no method to accurately identify patients at greatest risk for these long-term behavioral and neurocognitive problems. Through this proposal, this study plans to utilize existing data collected during acute treatment to identify predictors of long-term neurocognitive and brain maturation outcomes. The study also proposes to collect data on attention-deficit/hyperactivity disorder (ADHD) and associated comorbidities, higher order executive functions, and structural and functional brain imaging in survivors who are at least 8 years of age and greater than 5 years from diagnosis.
All patients will undergo a single neurocognitive evaluation focused on assessment of higher order executive functions. Patients will be evaluated during their regularly scheduled annual follow-up visit, when health-related monitoring will also occur. Parents of participants will be asked to complete questionnaires designed to assess the family environment and the impact of cancer diagnosis on family functioning and parent stress.
Brain Imaging: To better demonstrate untoward treatment effects upon cortical brain development, quantitative MR imaging of myelin integrity using diffusion tensor imaging (DTI) and cortical thickness assessment using high resolution volumetric imaging will be utilized. All patients will also be evaluated using functional MRI (fMRI) procedures during resting state and participation in attention and working memory tasks. fMRI and DTI data will be de-identified then analyzed at MD Anderson Cancer Center in Houston, Texas.
| Study Type : | Observational |
| Actual Enrollment : | 237 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | October 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Group 1
Survivors of pediatric leukemia treated on Total Therapy Protocol XV (TOTXV) at St. Jude Children's Research Hospital (SJCRH), who are ≥ 8 years of age and ≥ 5 years from diagnosis. Intervention: Neurocognitive and behavioral evaluation |
Other: Neurocognitive and behavioral evaluation
The primary neurocognitive outcome will be performance on measures of cognitive flexibility and cognitive fluency. Functional behavior will be evaluated via the child or adult version of the Behavior Rating Inventory of Executive Function, using parent respondent for each version. The presence of ADHD and common comorbid conditions (i.e. depression, anxiety) will be determined with structured diagnostic interviews. Quality of life will be re-assessed with the PedQL. |
- Neurocognitive assessment of attention, processing speed, and executive functions. [ Time Frame: Once, at least 5 years post ALL diagnosis and 2 years off treatment ]
- Quantitative magnetic resonance imaging (MRI) and DTI and functional magnetic resonance imaging (fMRI) of brain structure and function. [ Time Frame: Once, at least 5 years post ALL diagnosis and 2 years off treatment ]
- Family and parental stress as reported by primary caregiver. [ Time Frame: Once, at least 5 years post ALL diagnosis and 2 years off treatment ]
- Associations between genetic polymorphisms in key enzyme pathways and higher order brain development in long-term survivors of pediatric ALL. [ Time Frame: Once, at least 5 years post ALL diagnosis and 2 years off treatment ]
- Associations between fatigue and neurocognitive performance and between sleep problems and neurocognitive performance. [ Time Frame: Once, at least 5 years post ALL diagnosis and 2 years off treatment ]
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| Ages Eligible for Study: | 8 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Enrolled on SJCRH TOTXV ALL protocol
- ≥ 5 years post diagnosis of ALL
- ≥ 8.0 years of age at time of follow-up evaluation
Exclusion Criteria:
- History of cranial or total-body radiation therapy
- History of bone marrow transplant
- History of relapse
- History of head injury, neurological condition unrelated to ALL treatment, or diagnosis of a genetic disorder associated with neurocognitive impairment (e.g. Down Syndrome)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014195
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Principal Investigator: | Kevin Krull, Ph.D | St. Jude Children's Research Hospital |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01014195 History of Changes |
| Other Study ID Numbers: |
NEULS R01MH085849 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 16, 2009 Key Record Dates |
| Last Update Posted: | June 7, 2016 |
| Last Verified: | June 2016 |
Keywords provided by St. Jude Children's Research Hospital:
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Acute Lymphoblastic Leukemia Neurocognitive function ADHD |
brain imaging genetic polymorphisms Psychopathology and neurocognitive Impairment in Leukemia Survivors |
Additional relevant MeSH terms:
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |