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

Conditions

• Brain Neoplasm
• Recurrent Brain Neoplasm

Eligibility Criteria

Sex

ALL

Age

6 Years - 16 Years

Healthy Volunteers

Not accepted

Interventions

• Cognitive Assessment — PROCEDURE
  Ancillary studies
• Computer-Assisted Cognitive Training — OTHER
  Receive computer-assisted cognitive training
• Psychosocial Assessment and Care — PROCEDURE
  Ancillary studies
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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 tumor 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.

Key Dates

Start date

Jul 30, 2014

Status verified

Apr 2026

Primary completion

Dec 31, 2024

Study Design

Enrollment

45 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (interactive training program)
  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 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.
• Experimental: Arm II (non-adaptive training program)
  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 WIS-IV, the CMS, and the 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.

Primary Outcome Measure

Intervention Compliance [ Time Frame: Up to 9 weeks of starting training ]

Locations (27)

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