Status:
COMPLETED
Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Brain Tumor
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
8-16 years
Phase:
NA
Brief Summary
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated rates of working memory impairment. Working memory (WM) is the ability to hold and manipulate information on...
Detailed Description
Participants randomized to the intervention arm will complete the computerized working memory training program. This computer-based training program is completed in the home and requires approximately...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Screening Phase:
- Received CNS-directed treatment (intrathecal chemotherapy or cranial irradiation) for a BT or ALL
- Infratentorial tumor location (for the BT cohort)
- Off treatment for at least one year with no evidence of recurrent or progressive disease
- Age 8-16 years inclusive at the time of enrollment
- English as the primary language
- Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
- Exclusion Criteria for Screening Phase
- Significant impairment in global intellectual functioning (estimated or full scale IQ \< 70 based on standardized testing routinely conducted on primary treatment protocols)
- History of CNS injury/disease predating or unrelated to cancer diagnosis
- Documented ADHD predating cancer diagnosis
- Treatment with psychostimulant or psychotropic medication within two weeks of study participation
- Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, psychosis)
- Inclusion Criteria for Intervention Phase
- Signed screening consents and has undergone screening
- Fully evaluable psychological testing results (including IQ \> or = 70)
- Age-scaled score on Digit Span, Letter-Number Sequencing or Spatial Span \< 7 OR at least one standard deviation below IQ score
- Training aide is available to participate in required sessions
- Participant and training aide demonstrate computer proficiency
- Participant has access to or will be provided a laptop or home computer with internet connection and speakers
- Participant willing to participate in required aspects of computerized intervention
- Participant is able to take part in fMRI without sedation
- Exclusion Criteria for Intervention Phase
- Major psychological condition that would preclude completion of protocol intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms)
- Orthodontic appliances that cause MRI distortion or signal loss outside the mouth and sinus area
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01217996
Start Date
October 1 2010
End Date
November 1 2013
Last Update
April 29 2014
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105