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TRICCS: Targeting Inattention in Childhood Cancer Survivors

Phase 2
8 Years
16 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia, Brain Tumor, Working Memory Deficits

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Trial Information

TRICCS: Targeting Inattention in Childhood Cancer Survivors

Since the 1960's there has been a marked increase in the 5-year survival rates among
children diagnosed with cancer. Despite the favorable prognosis for survival, patients are
at high risk for both acute and late occurring sequelae associated with their disease and
treatments. Children who receive therapies that impact the central nervous system are at
even higher risk for cognitive, social and psychological deficits. Collectively, these
problems limit their quality of survival well into adulthood. As such, investigators have
recently focused on development of interventions targeted at improving neurocognitive
deficits in survivors, particularly problems with attention and working memory. One novel
approach that has shown preliminary and robust efficacy in children with attention problems
is computerized cognitive training (CT). However, such an intervention has never been
empirically tested with survivors of childhood cancer. Therefore, given the preliminary
nature of this field of investigation, prior to launching a large-scale randomized clinical
trial, it is first of crucial importance to determine whether this type of home-based,
computerized cognitive training task is feasible and acceptable for use with survivors of
pediatric cancer. To this end, the current study has two specific aims: 1) to assess the
feasibility and acceptability of a home-based, computerized attention training program with
survivors of central nervous system (CNS) impacting pediatric cancer (e.g. ALL, brain
tumors), and 2) to estimate the effect size of this attention training program with
survivors of childhood cancer to determine whether a larger-scale clinical trial is
warranted. We propose to pilot an 8-week randomized, placebo-controlled, CT intervention
with a small sample of survivors of childhood cancer (n = 24). Feasibility, acceptability,
and preliminary efficacy data will be collected post-treatment and after a 3-month follow-up
period. Primary outcomes will be parent- and survivor-reported technical feasibility,
ease-of-use, and satisfaction, as well as computer-tracked compliance, and performance on
standardized measures of attention and working memory. We hypothesize that the intervention
will be associated with adequate feasibility, acceptability, and compliance. Further, we
predict that increases in working memory and attention from baseline to post-intervention
will be of moderate effect size, and will be maintained at 3-month follow-up.

Inclusion Criteria:

- at least one year off-treatment for acute lymphoblastic leukemia OR brain tumor

Exclusion Criteria:

- a motor, visual, or auditory handicap that prevents computer use

- a diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant
Disorder, depression, autism, or Pervasive Developmental Disorder

- insufficient fluency in English

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Working Memory Index from the Wechsler Intelligence Scale for Children - Fourth Edition and the Memory Scales from the Wide-Range Assessment of Memory and Learning

Outcome Time Frame:

end of treatment and 3-month follow-up

Safety Issue:


Principal Investigator

Kristina K Hardy, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

October 2009

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Brain Tumor
  • Working Memory Deficits
  • Working memory
  • Acute lymphoblastic leukemia
  • Brain tumor
  • Cognitive training
  • Brain Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Memory Disorders



Duke University Medical Center Durham, North Carolina  27710