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

NCT07044076 | Recruiting

• 1 other identifier: D25 - P003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; Meningioma

Outcome Measures

Primary Outcomes (1)

• meningioma-specific quality-of-life questionnaire

  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.

  1 month

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of three groups to ensure maximum heterogeneity: 1. The study will be announced to all patients seen in consultation for meningioma at GHU Paris - Sainte-Anne (France). 2. All patients who are members of the AMAVEA association will be notified of the study by email. 3. Any patient referred by partner teams following a call for participation within the Neuro-Oncology Club and the Skull Base Club of the French Neurosurgery Society, recruited under the same procedure as the AMAVEA association.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris -Psychiatrie & Neurosciences

Paris, 15014, France

RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Viviane AWASSI

CONTACT

01.45.65.84.86; v.awassi@ghu-paris.fr

Benoît HUDELIST, Dr

CONTACT

benoit.hudelist@ghu-paris.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 29, 2025
• Study Start: June 13, 2025
• Primary Completion: July 13, 2025
• Study Completion: December 12, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

FR (1)