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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Feasibility of obtaining serial computer-based neurocognitive testing as measured by an acceptance rate of 60% of eligible patients. [Срок оценки: At the completion of enrollment of all patients (estimated to be 9 years)]
• Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors [Срок оценки: 12 months]
• Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT02559752 · 201509033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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