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

Titre officiel

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

Sommaire:

Cet essai clinique à répartition aléatoire étudie l’efficacité d’un programme d’entraînement cognitif informatisé adaptatif, comparativement à un programme d’entraînement cognitif informatisé non adaptatif, dans le traitement de jeunes patients avec une tumeur au cerveau ayant subi de la radiothérapie. Le fait de fournir un programme d’entraînement informatisé aux patients avec des difficultés cognitives (physiques et mentales) causées par la radiothérapie au cerveau pourrait contribuer à améliorer leur bien-être et leur qualité de vie.

Description de l'essai

Primary Outcome:

• Proportion of patients with intervention compliance

PRIMARY OBJECTIVES:

• 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.

EXPLORATORY OBJECTIVES:

• 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.

OUTLINE: Patients are randomized to 1 of 2 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.

After completion of study treatment, participants are followed up within 3 weeks, then at 6 months.

Voir cet essai sur ClinicalTrials.gov