NCT05733091招募中不适用
Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)
研究概览
简要总结
To learn about the symptoms and changes our patients experience while receiving treatment for sinonasal or nasopharyngeal cancer
详细描述
Objectives:
- To estimate the prevalence and severity of adverse and functional outcomes in survivors of benign and malignant paranasal sinus, nasopharynx and skull base tumors.
- To estimate the prevalence of health promotion behaviors during skull base tumor survivorship
- To identify possible mediators or predictors of survivorship outcomes and health behaviors in survivors of skull base tumors.
- To develop a database of demographic, clinicopathologic, recurrence, survival, functional and patient reported outcomes (PROS) for patients with benign and malignant paranasal sinus, nasopharyngeal and skull base tumors.
- To assess the utility and limitations of PROs in evaluating functional impairments and symptom burden in skull base patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated patients with or suspected to have sinonasal malignancy or nasopharyngeal malignancy diagnosis based on either outside pathology report or MD Anderson pathology report.
- •Age ≥ 18 years
- •Plan to obtain the majority of treatment at MDACC including surgery and radiotherapy
- •Ability to understand and willingness to sign written informed consent
排除标准
- •History of the previous solid or liquid malignancies, apart from skin cancers treated with local therapy.
- •Existing neurocognitive impairment that is not the result of sinonasal and nasopharyngeal cancers or is treatment.
- •Previous treatment for sinonasal or nasopharyngeal carcinomas, apart from biopsy.
结局指标
主要结局
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN)
时间窗: through study completion; an average of 1 year
MD Anderson Symptom Inventory Head and Neck Module (MDASI-HN) is a disease specific PRO instrument validated for patients with head and neck cancer. It is the most commonly utilized instrument in the head and neck cancer population, of which sinonasal and nasopharyngeal tumors are disease subsites. Score scale from 0 (symptom has been present) to 10 (the symptom was as bad as you can imagine it could be)
次要结局
未报告次要终点
研究者
研究点 (2)
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