Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
- Conditions
- Brain TumorAcute Lymphoblastic Leukemia
- Interventions
- Behavioral: Computerized working memory training program (intervention)Behavioral: Computerized working memory training program (control)
- Registration Number
- NCT01217996
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Computerized working memory training program (intervention) Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (intervention). Control Group Computerized working memory training program (control) Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (control).
- Primary Outcome Measures
Name Time Method This study will measure working memory, attention and executive functions Baseline, 10 weeks, and 6 months Participants in the working memory intervention will demonstrate significantly greater improvement from pre- to immediate post-intervention on performance- and rater-based measures of working memory relative to childhood cancer survivors placed on an intervention waitlist.
- Secondary Outcome Measures
Name Time Method This study will examine the neural correlates of working memory before and immediately after intervention Baseline and 10 weeks. This objective will use fMRI to examine the neural correlates of working memory before and immediately after intervention.
The study will measure the maintenance of improvements on measures of working memory, attention and executive functions 6 months. The improvements will be evaluated at six months following participation in the computer-based intervention program.
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States