Expired Study
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Durham, North Carolina 27710


Purpose:

The purpose of 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 evaluate the efficacy of this attention training program with survivors of childhood cancer. 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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00735202


Primary Contact:

Principal Investigator
Kristina K Hardy, PhD
Duke University Health System


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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