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临床试验/NCT04004377
NCT04004377Unknown不适用

Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年12月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Score of PANQUOL Questionnaire

研究概览

简要总结

This study has investigated the quality of life of patients with vestibular schwannoma using this specific scale prospectively, whether treated surgically or monitored.

详细描述

The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.

Three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a "normal" life, and the third assessing difficulties in working life.

The questionnaires are sent to the patient in the form of a custom web link generated on the online survey platform SurveyMonkey, and integrated into the body of an email sent from the mailbox of the investigator Hospital. There is any identifying or indirectly identifying data on the questionnaire online, guaranteeing protection of the rights of the individual. Only the principal investigator and co-investigator retain the link between the coded identity of persons undergoing research used to associate personal health data and their name (s) and name (s) (correspondence table retained securely to the paper).

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • be in possession of an acoustic neuroma (or vestibular schwannoma) confirmed in MRI, unilateral, unoperated
  • Age over 18 years
  • patient insured or beneficiary of a social security scheme
  • free, informed and express

排除标准

  • History of surgery of the angle ponto-cerebellar or otologic
  • Neurofibromatosis type 2
  • Cons-indication to MRI
  • psychiatric pathology
  • Pregnant or breastfeeding women

结局指标

主要结局

Score of PANQUOL Questionnaire

时间窗: Month 12

The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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