Computer Training Program for Younger Patients With a Brain Tumour Who Underwent Radiation Therapy

Official Title

Computerized Cognitive Training for Pediatric Brain Tumour Patients: A Pilot Study

Summary:

This randomized clinical trial studies how well an adaptive computerized cognitive training program works compared to a non-adaptive computerized cognitive training program in treating younger patients with brain tumour who underwent radiation therapy. Providing a computer training program may improve the well-being and quality of life of patients with cognitive (physical and mental) function difficulties caused by radiation therapy to the brain.

Trial Description

Primary Outcome:

• Intervention compliance defined as at least 80% of sessions completed (i.e., completing at least 20 sessions within 9 weeks of starting training)

Secondary Outcome:

• Parent-rated executive function and WM using the Metacognition subscales from the Behaviour Rating Inventory of Executive Function (BRIEF)
• Executive function using the Groton Maze Learning and Set Shifting tasks of the CogState battery
• WM by the Two-back task from CogState and Digit Span from Wechsler Intelligence Scales
• Verbal and visual memory using Dot Location from Children's Memory Scale Spatial Span from Wechsler Scale
• Technical feasibility based on the item responses to the 13-item Feasibility Interview
• Adherence
• Satisfaction and ease of use

OBJECTIVES:
I. To assess the feasibility of a home-based, computerized, cognitive training program for patients with pediatric brain tumours who are undergoing cranial radiation therapy (CRT), treated in multiple Children Oncology Group (COG) institutions. II. To estimate the effect size of this program on measures of attention and working memory in patients with brain tumours treated with CRT in order to design a definitive large-scale clinical trial. (Exploratory) OUTLINE:

This is a multicentre study. Patients are stratified according to risk factors, including age (< 8 years vs ≥ 8 years) and 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 behaviours, 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.

View this trial on ClinicalTrials.gov