Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy

The Washington University

Status: Enrolling

Conditions: Central Nervous System

Treatments: Other: NIH Toolbox Cognitive Battery

Study type: Observational

Funder types: Other

Identifiers

NCT02559752

201509033

Details and patient eligibility

About

This study will explore neurocognitive performance in pediatric brain tumor patients receiving proton beam radiation therapy (PBRT). The investigators goal is to gather baseline neurocognitive testing prior to the completion of the first week of radiation therapy along with follow-up testing 6-12 months after the completion of radiation and serial annual testing thereafter. With these data the investigators plan to evaluate the effects of PBRT on neurocognitive performance as it relates to patients' age at diagnosis, tumor location, and radiation dose. Modeling studies have demonstrated that PBRT could improve neurocognitive outcomes, but there is a paucity of prospectively-collected patient data. The investigators are uniquely positioned to address this important question given the busy pediatric central nervous system (CNS) tumor service, the delivery of proton therapy at the S. Lee Kling Proton Therapy Center at Barnes-Jewish Hospital, and the multi-disciplinary research team with extensive experience into the late effects of therapy as it relates to neurocognition.

Enrollment: 80 estimated patients

Sex: All

Ages: 4 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of primary CNS tumor or diagnosis of metastatic disease to the CNS with an expected overall survival of > 1 year. Any prior treatment (chemo, XRT, or surgery) is allowed.
• Planning to receive PBRT to treat the CNS tumor. Patients who have already received PBRT for this disease may also be enrolled provided they completed the NIH Toolbox Cognitive Battery prior to the first week of radiation therapy.
• Between 4 and 21 years of age (inclusive).
• Life expectancy of at least one year.
• Absence of visual impairment that would impede computer testing.
• No secondary health conditions that would impact cognitive functioning (e.g. psychiatric or developmental disability unrelated to cancer).
• Able to understand and willing to sign IRB-approved written informed consent document (or signature of legally authorized representative).

Trial design

80 participants in 1 patient group

Arm 1: NIH Toolbox Cognitive Battery testing

Description:

* This study will use the NIH Toolbox Cognitive Battery computer testing software to investigate the cognitive outcomes in children with CNS tumors receiving PBRT. * Participants recruited for the study will complete one 45-minute testing session prior to the completion of the first week of radiation therapy. * They will then complete serial tests 6-12 months after the completion of PBRT and then yearly thereafter.

Treatment:

Other: NIH Toolbox Cognitive Battery