Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
8 Years
16 Years
Both
Brain Tumor, Acute Lymphoblastic Leukemia
Trial Information
Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
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 30 minutes every weekday for five weeks. The program software guides
the child through eight rotating exercises each day, with increasing difficulty based on the
child's level of performance. Exercises train both visuospatial and verbal WM using
child-friendly activities. A research team member will serve as a coach who monitors weekly
progress online and offers support through weekly phone calls with the study participants
and their caregivers. This individual will not complete post-intervention assessments to
maintain study blind. A home computer with internet connection and speakers is required. A
laptop computer and/or wireless internet access will be provided to families whose only
obstacle to participation is lack of computer access or internet connectivity in the home
setting. Families randomized to the WM intervention will complete a tutorial with study
staff that provides instruction in using a computer, the internet and the WM training
software.
The objective of this study is to investigate the benefits of this working memory
intervention in a sample of childhood cancer survivors and look at brain-based changes that
may occur as the result of working memory intervention. To achieve this goal, we plan to
study childhood cancer survivors randomly assigned to the working memory intervention or a
passive waitlist. Both groups will participate in cognitive testing pre-, post-, and six
months post intervention. Intervention participants will also partake in neuroimaging exams
before and after the intervention. Findings from this study have direct potential to
support a nonpharmaceutical cognitive intervention for cancer survivors that is a safe and
effective alternative to stimulant medications with great promise for improving quality of
life.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
This study will measure working memory, attention and executive functions
Outcome Description:
Participants in the working memory intervention will demonstrate significantly greater improvement from pre- to immediate post-intervention on performance- and rater-based measures of working memory relative to childhood cancer survivors placed on an intervention waitlist.
Outcome Time Frame:
Baseline, 10 weeks, and 6 months
Safety Issue:
No
Principal Investigator
Heather M Conklin, Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Institutional Review Board
Study ID:
COGTRN
NCT ID:
NCT01217996
Start Date:
October 2010
Completion Date:
September 2013
Related Keywords:
- Brain Tumor
- Acute Lymphoblastic Leukemia
- working memory intervention
- memory impairment
- cognitive late effects
- Childhood Cancer Survivors
- Brain Neoplasms
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
