Inattention in Childhood Cancer Survivors
Condition: Childhood Cancer
Study type: Interventional

Summary: 
      Specific Aim 1: To assess the feasibility and acceptability of a home-based, computerized
      cognitive training program with survivors of central nervous system-impacting pediatric
      cancer (e.g. acute lymphoblastic leukemia, brain tumors).

      Specific Aim 2: To estimate the effect size of this cognitive training program on measures of
      attention and working memory in survivors of childhood cancer in order to determine whether a
      larger-scale clinical trial is warranted.
    

Detailed description: 
      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.
    

Intervention name(s): Attention Training; Placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computer program training for attention difficulties.; Comparison computer program
Other intervention name(s): TRICCS; RoboMemo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatric; Brain Tumor; Acute Lymphoblastic Leukemia; Inattention; Childhood cancer survivors