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

This study is currently recruiting participants.
Verified March 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02559752
First Posted: September 24, 2015
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention
Central Nervous System Other: NIH Toolbox Cognitive Battery Device: Proton Beam Radiation Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an acceptance rate of 60% of eligible patients. [ Time Frame: At the completion of enrollment of all patients (estimated to be 2 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 [ Time Frame: 12 months ]
    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.

  • Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors [ Time Frame: 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.


Estimated Enrollment: 40
Actual Study Start Date: October 13, 2015
Estimated Study Completion Date: October 30, 2020
Estimated Primary Completion Date: October 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: NIH Toolbox Cognitive Battery testing
  • 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.
Other: NIH Toolbox Cognitive Battery
  • For ages 4 to 7 years, the NIH Toolbox Early Childhood Battery will be administered. This test includes the Picture Vocabulary, Flanker Inhibitory Control and Attention, Dimensional Change Card Sort, and Picture Sequence Memory measures to evaluate language, executive function, attention, and episodic memory, respectively.
  • For patients age 8 years or older, the administered battery will consist of the aforementioned tests in addition to Oral Reading Recognition, Pattern Comparison Processing Speed, and List Sort Working Memory tests. Results will include scores for each individual measure. In addition, each cognition battery provides composite scores, which allow for general interpretation/evaluation of overall cognitive functioning.
Device: Proton Beam Radiation Therapy
-Standard of care
Other Name: PBRT

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary CNS tumor. 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559752


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

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Stephanie Perkins, M.D.    314-747-4405    sperkins@wustl.edu   
Contact: Lindsey Brunt, BS    314-362-6532    bruntl@wustl.edu   
Principal Investigator: Stephanie Perkins, M.D.         
Sub-Investigator: Allison King, M.D.         
Sub-Investigator: Jonathan Dodd, PsyD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Stephanie Perkins, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02559752     History of Changes
Other Study ID Numbers: 201509033
First Submitted: September 17, 2015
First Posted: September 24, 2015
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases


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