Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
Condition: Brain Tumor; Acute Lymphoblastic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated
      rates of working memory impairment. Working memory (WM) is the ability to hold and manipulate
      information online; for example, when an individual mentally rehearses a phone number in
      order to dial it without writing it down. A computer-based working memory intervention has
      been successful in children diagnosed with ADHD and stroke survivors. Individuals
      participating in the intervention showed improvements on working memory measures as well as
      more complex problem solving skills. Neuroimaging (brain scans) conducted before and after
      training showed changes in brain activation suggestive of underlying changes in brain systems
      that support working memory. This study investigates the effectiveness of this computer-based
      working memory intervention for childhood cancer survivors.
    

Detailed description: 
      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.
    

Intervention name(s): Computerized working memory training program (intervention); Computerized working memory training program (control)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A computer-based training program will be completed in the home. This program 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). Intervention participants will also partake in neuroimaging exams before and after the intervention; Participants randomized to the control group will not complete any intervention during the intervention time period and will not partake in neuroimaging exams. They will complete an immediate and six month post follow-up cognitive assessment. Following completion of these assessments, they will be provided the opportunity to complete the computer-based training program off study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: working memory intervention; memory impairment; cognitive late effects; Childhood Cancer Survivors