跳至主要内容
临床试验/NCT07044076
NCT07044076招募中不适用

Translation and Validation of the MQOL Self-questionnaire Into French for Assessing Quality of Life in Patients With Meningiomas

Centre Hospitalier St Anne1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
meningioma-specific quality-of-life questionnaire

研究概览

简要总结

Meningiomas, which account for about 40% of primary central nervous system tumors, have significant psychological and social impacts, even without treatment. Their effect on quality of life is often underestimated and poorly documented. There is one validated questionnaire (MQOL) but it has not yet been translated into French. The project involves two phases: first, translating and linguistically validating the MQOL into French; second, scientifically validating the questionnaire with 50 meningioma patients using established scales (EQ-5D, Karnofsky, FACT-Br) to ensure its reliability and internal consistency.

研究设计

研究类型
Observational
观察模型
Other
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

  • •Patient aged 18 years or older
  • •Diagnosis of intracranial meningioma confirmed by imaging or surgery

排除标准

  • •Pregnant or breastfeeding women (Article L1121-5)
  • •Patients deprived of liberty by judicial or administrative decision, as well as individuals undergoing psychiatric care (Article L1121-6)
  • •Patients not fluent in French or with poor understanding of the language
  • •Inability to refuse participation in the study

结局指标

主要结局

meningioma-specific quality-of-life questionnaire

时间窗: 1 month

The meningioma-specific quality-of-life questionnaire (MQOL) is an self-administered questionnaires and a validated tool used in practice in English, specifically applicable to patients with meningiomas, and was developed by a Canadian team (Baba A, Saha A, McCradden MD, Boparai K, Zhang S, Pirouzmand F, Edelstein K, Zadeh G, Cusimano MD. Development and validation of a patient-centered, meningioma-specific quality-of-life questionnaire. J Neurosurg. 2021 May 14;135(6):1685-1694. doi: 10.3171/2020.11.JNS201761. PMID: 33990085.) This project will involve applying the MQOL to a population of 50 patients and comparing it with self-administered questionnaires already validated in French practice (FACT-Br, Karnofsky, and EQ-5D). The purpose of all these questionnaires is to assess quality of life in patients. The EQ-5D and Karnofsky evaluate it in a general manner, while the FACT-Br is used in an oncological context.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Sponsor

研究点 (1)

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