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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07044076
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Hospitalier St Anne
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Quality of Life, Meningioma

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