跳至主要内容
临床试验/NCT05157555
NCT05157555Unknown不适用

Quality of Life in Patients After Pharyngolaryngectomy

Université de Reims Champagne-Ardenne1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
EORTC QLQ-C30

研究概览

简要总结

Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.

详细描述

The aim of the study is to describe quality of life in patients with laryngectomy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female
  • with laryngectomy
  • agreeing to participate in the study

排除标准

  • less than 18 years old

结局指标

主要结局

EORTC QLQ-C30

时间窗: Day 0

The QLQ-C30 is a generic questionnaire with 30 questions coded in 4 response modalities (not at all (1), a little (2), enough (3), a lot (4)) or in 7 response modalities (from very bad (1) to excellent ( 7)). Questions are summarized in five multiitem domains (physical, role, cognitive, emotional, and social functioning) and nine single item domains (fatigue, pain, nausea/vomiting, appetite loss, financial impact; diarrhea, constipation, sleep disturbance and quality of life). Each domain is scored between 0 and 100. For functional domains, a high score value represents a high level of quality of life. For symptom domains, a high score represents an important level of symptoms (a low level of quality of life).

次要结局

未报告次要终点

研究者

发起方
Université de Reims Champagne-Ardenne
申办方类型
Other
责任方
Sponsor

研究点 (1)

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