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临床试验/NCT03066167
NCT03066167已完成不适用

Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer

Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Validation of dysphagia scores

研究概览

简要总结

This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language.

详细描述

In the present study, our aim was to firstly, validate 3 commonly used scales for use in patients with dysphagia due to malignancy, and secondly, to validate them in the Swedish language. The 3 scales were: The Watson dysphagia scale, which was developed in studies on surgical treatment of reflux disease. It consists of questions about food with 9 different viscosity and solidity and the patient answer if they have problems with a specific food: never, sometimes or always when ingesting this. The scores are added and provides a range of 0-45 where 45 is the worst possible dysphagia. The Ogilvie score is a 5-graded scale 0-4 where 4 is total inability to swallow. The Goldschmid score is graded from 0-5 where 0 is inability to swallow and 5 is normal function. QoL was measured with validated instruments originating from the European Organization for Research and Treatment of Cancer (EORTC), which has a generic instrument that measures global QoL in patients with cancer (QLQ-C30) and a more symptom-specific instrument that is developed for cancer in the oesophagus and stomach (QLQ-OG25). These are well known, validated instruments that also have normal reference values for the healthy population. The symptom specific instrument QLQ-OG25 includes a dysphagia module consisting of 3 questions which is validated to malignant disease and food intake with the help of expert groups and deep interviews with patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Cancer in the gastro-esophageal junction or in the esophagus
  • Dysphagia
  • Ability to fill in the questionnaires
  • Written acceptance of the informed consent

排除标准

  • Not for-filling inclusion criteria
  • No consent

结局指标

主要结局

Validation of dysphagia scores

时间窗: 10-14 days

Translation of scores to the Swedish language

时间窗: 10-14 days

次要结局

未报告次要终点

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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