Идёт набор NCT06981156

Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)

— Наблюдательное Pediatric Brain Tumor Pediatric Spine Tumor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: pNANO Assessment.
Кому может быть актуально: Состояния в реестре: Pediatric Brain Tumor, Pediatric Spine Tumor. Базовые параметры: 1 год — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to investigate a neurologic exam scale to provide an objective and more standard way to assess tumor response in pediatric patients with brain and spinal cord tumors.

Подробное описание

This study is designed to evaluate inter-observer variability of the pNANO scale when implemented during routine clinic visits for pediatric brain and spine tumor patients. Typically, during a routine clinic visit for patients with pediatric brain and spine tumors, a neurological examination is completed and documented by a provider in clinic notes under the section 'Physical examination', sub-heading 'Neurologic examination.'

For this study, every participant will have neurologic examinations performed by 2 or 3 (if feasible), separate providers on the same day (patient's scheduled provider and one or two additional providers from the Study Team), during a scheduled, routine clinic visit(s). To allow for potential significant discrepancies in exams between two providers, if feasible, a third provider will complete an examination at each visit. Each provider will independently perform the neurologic examination and will document the findings on the pNANO scale scorecard.

Each provider will also record the amount of time it took to complete their neurologic examination. The providers will not communicate with each other about the findings and will be completely blinded to each other's evaluations.

The pNANO scale will be completed at a second clinic visit, between 1-6 months out from the initial assessment. Telemedicine visit evaluations will be allowed for 20% of patients enrolled on study to assess if this scale is feasible via telemedicine. For telemedicine visits, one provider will need to be in clinic to complete the first examination and the second provider will be virtual to complete the second examination on the same day. A third provider would need to be in clinic to complete an examination.

For the second evaluation 1-6 months after the first, the same will apply, one or two providers in clinic to complete the first examination while the second/third provider will be virtual. Providers can include physicians and advanced practice providers of any subspecialty: neurology, hematology-oncology, radiation oncology, neurosurgery, physical medicine and rehabilitation.

Вмешательства

Диагностический тест pNANO Assessment
pNANO assesses patient gait, strength, cerebellar function, visual fields, visual acuity, facial strength, level of consciousness, extraocular movement, dysarthria, and dysphagia The patient will be assessed by 2-3 different clinicians during each of 2 visits.

Первичные конечные точки

Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores [Срок оценки: Visit 1 (baseline), Visit 2 (up to 6 months)]

Вторичные конечные точки (2)

Feasibility: Clinical Exams that may correlate with pNANO scores [Срок оценки: Visit 1 (baseline), Visit 2 (up to 6 months)]
Feasibility: Inter-observer variability of pNANO scores between in clinic visits and Telemedicine reported as Difference in Mean Cumulative Scores [Срок оценки: Visit 1 (baseline), Visit 2 (up to 6 months)]

Критерии участия

Критерии включения

greater than or equal to 1 year old
must be seen in the pediatric clinic
Radiographic or histologic confirmation of a brain or spine tumor at the time of initial diagnosis
Patient or parent/guardian must be able to understand the consent and be willing to sign a written informed consent document according to institutional guidelines.