Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study
OBJECTIVES:
- To assess the feasibility of a home-based, computerized, cognitive training program for
patients with pediatric brain tumors who are undergoing cranial radiation therapy
(CRT), treated in multiple Children Oncology Group (COG) institutions.
- To estimate the effect size of this program on measures of attention and working memory
in patients with brain tumors treated with CRT in order to design a definitive
large-scale clinical trial. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to known risk
factors including age (< 8 years vs ≥ 8 years), treatment intensity (whole brain vs focal
radiation). Patients are randomized to 1 of 2 intervention arms.
- Arm I (intervention): Patients undergo a home-based, computerized, interactive training
program comprising 3-5 sessions of 15-45 minutes every week for 5-9 weeks. The program
contains twelve visually engaging and interesting exercises that target skills
involving visual-spatial and verbal working memory (WM). The program is adaptive in a
way that each difficulty task is automatically adjusted on a trial-by-trail basis to
match a patient's current WM. Each patient has an interventional coach who has online
access to patient's training sessions and outcomes (pass or fail). Coaches are able to
modify the training sequence or make suggestions to patients and/or parents about how
progress can be maximized. Coaches also have telephone meetings with patients and/or
families once a week to ensure compliance, track progress, provide feedback, and answer
questions that arise during training.
- Arm II (control): Patients undergo a home-based, computerized, interactive,
non-adaptive training program comprising 3-5 sessions of 15-45 minutes a week for 5-9
weeks. Each patient also has an interventional coach as in arm I.
Patients in both arms complete a brief neuropsychological/behavioral assessment comprising
the Wechsler Intelligence Scale for Children (WIS-IV), the Children's Memory Scale (CMS),
and the California Verbal Learning Test-Children's Version (CVLT-C) at baseline, after
completion of study, and at 6 months after completion of study. Additionally, parents
complete a parent-report questionnaire to gather information about patient's behaviors,
thoughts, emotions, adaptive skills, and social and functional impairment. Parents and
children also complete surveys about the program regarding technical feasibility, adherence,
ease-of-use, and satisfaction.
Observational
N/A
Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training)
No
Kristina Hardy, PhD
Principal Investigator
Children's Research Institute
Unspecified
CDR0000721387
NCT01503086
January 2012
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