Evaluation of the Neurologic Assessment in Pediatric Neuro-Oncology (pNANO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •none specified
结局指标
主要结局
Inter-observer Variability in pNANO Scores: Difference in Mean Cumulative Scores
时间窗: Visit 1 (baseline), Visit 2 (up to 6 months)
The Pediatric Neurologic Assessment in Neuro-Oncology (pNANO) is scored in multiple domains: - strength, level of consciousness, and gait domains (each individually scored 0-3) * facial strength, cerebellar function, visual fields, extraocular movements, dysphagia, and dysarthria domains (each individually scored 0-2) * visual acuity domain scored from 0-1 If summed, cumulative scores range from 0 (normal) to 22 (inability to function in each relevant domain) Investigators will explore variability across all domains.
次要结局
- Feasibility: Clinical Exams that may correlate with pNANO scores(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(Visit 1 (baseline), Visit 2 (up to 6 months))