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

NCT07044076 — Recruiting, 50 participants, Centre Hospitalier St Anne

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Registry	NCT07044076, acronym MenQOL
Status	Recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	Centre Hospitalier St Anne (Other)
Conditions	Quality of Life, Meningioma
Interventions	Quality of life (Other)
Dates	start 2025-06-13, primary completion 2025-07-13 (estimated), completion 2025-12-12 (estimated), first posted 2025-06-29, last updated 2025-06-29
Locations	1 site in France

-Summary

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.

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+Arms and interventions

Quality of life (Other): The four questionnaires (MQOL, EQ-5D, Karnofsky, and FACT-Br) will be sent to patients online using the secure online platform Redcap.

+Outcome measures

Primary outcomes

meningioma-specific quality-of-life questionnaire [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
GHU Paris -Psychiatrie & Neurosciences	Paris	France	Recruiting