RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-10-13
Study Completion:2030-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02559752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Between 4 and 21 years of age (inclusive).
  4. * Life expectancy of at least one year.
  5. * Absence of visual impairment that would impede computer testing.
  6. * No secondary health conditions that would impact cognitive functioning (e.g. psychiatric or developmental disability unrelated to cancer).
  7. * Able to understand and willing to sign IRB-approved written informed consent document (or signature of legally authorized representative).
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Stephanie Perkins, M.D.
CONTACT
314-747-4405
sperkins@wustl.edu
Lindsey Brunt, BS
CONTACT
314-362-6532
bruntl@wustl.edu

Principal Investigator

Stephanie Perkins, M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Stephanie Perkins, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-10-13
Study Completion Date2030-04-30

Study Record Updates

Study Start Date2015-10-13
Study Completion Date2030-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Central Nervous System