TRICCS: Targeting Inattention in Childhood Cancer Survivors
After obtaining written informed consent (parent) and assent (child), screening procedures
will include administration of an abbreviated intellectual test battery, a working memory
battery, and a computerized attention measure to the survivor (see specific Measures below).
Our goal is to enroll 24 (12 ALL, 12 brain tumor) participants in the intervention phase of
this prospective pilot study. To reach this goal, we anticipate needing to screen
approximately 50 survivors, though enrollment will end when, or continue until, 24 eligible
participants are identified and randomized to the intervention phase. Parents will complete
questionnaire measures regarding their child's adaptive, behavioral, emotional, and
attentional functioning. Follow-up interviewing will be conducted to clarify any potential
problems identified on the questionnaires. The entire screening procedure is estimated to
take approximately 90 minutes for the survivor and 30-45 minutes for parents. To maximize
efficiency, two study personnel will work with families - one will complete testing with the
child, while the other will complete questionnaires and follow-up interviewing with the
parent. The design will be a double-blind, placebo-controlled trial in which half of the
participants will be randomized to the intervention condition and half will receive a
comparison computer program. Specifically, participants assigned to the comparison
(placebo) condition will complete a modified version of the CT at home. The treatment and
comparison CT programs begin identically, at the lowest difficulty level. Those in the
treatment condition will complete activities of increasing difficulty over the intervention
period. Those in the placebo condition, in contrast, will complete the same basic tasks
during each session of the intervention, regardless of performance. In this way, a true
estimate can be obtained of the efficacy of the treatment program.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Memory
2 months and 3 months
No
Kristi Hardy, PhD
Principal Investigator
Duke University
United States: Institutional Review Board
Pro00003249
NCT00636337
December 2007
November 2012
Name | Location |
---|---|
Duke University Medical Center Preston Robert Tisch Brain Tumor Center | Durham, North Carolina 27710 |