Computer-Assisted Cognitive Training for Brain Tumor

Recruiting in Palo Alto (17 mi)

+30 other locations

Overseen byKristina K Hardy

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies how well an adaptive computer-based training program works for younger patients with brain tumors who have had radiation therapy. The program adjusts its difficulty based on the patient's performance to help improve their memory and attention.

Eligibility Criteria

This trial is for young patients with brain tumors who have finished radiation therapy within the last 4 months. They need to have a caregiver, access to a phone, and understand English. Patients with traumatic brain injury before their tumor diagnosis, pontine glioma, IQ < 70 or severe disabilities that prevent computer use are not eligible.

Inclusion Criteria

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

I have someone willing to help me during my treatment.

I have a phone and can be contacted.

See 4 more

Exclusion Criteria

Patients with an estimated survival of less than one year

Patients with a history of traumatic brain injury prior to tumor diagnosis

I have a brain tumor located in the pons.

See 2 more

Treatment Details

Interventions

Computer-Assisted Cognitive Training (Behavioural Intervention)

Trial OverviewThe study compares an adaptive computerized cognitive training program against a non-adaptive one to see if they can improve mental function and quality of life after brain radiation therapy in younger patients with brain tumors.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Arm II (non-adaptive training program)Experimental Treatment5 Interventions

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.

Group II: Arm I (interactive training program)Experimental Treatment5 Interventions

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.