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

Recruiting

• Conditions: Central Nervous System
• Interventions: Other: NIH Toolbox Cognitive Battery

• Registration Number: NCT02559752
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Study Start: 2015-10-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1: NIH Toolbox Cognitive Battery testing	NIH Toolbox Cognitive Battery	* 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.

Primary Outcome Measures

Name	Time	Method
Feasibility of obtaining serial computer-based neurocognitive testing as measured by an acceptance rate of 60% of eligible patients.	At the completion of enrollment of all patients (estimated to be 9 years)	The acceptance rate will be a proportion of those who consent to participation over the total number of eligible and approached participants. The 60% acceptance rate is chosen because previous behavioral science intervention study participation in pediatric hematology and oncology ranges from 42% to 90%.
Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors	5 years	An implementation rate will be calculated by tracking the proportion of consented participants who complete at least two assessments in the first year of follow up. The primary length of time for implementation is in the first 12 months, but the rate of implementation will be tracked for up to five years for each participant. This is consistent with a two-staged assessment from Butler's remediation trial.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States