Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas

NCT07376473 | Not Yet Recruiting

• 1 other identifier: D25-P039
• Study Type: observational
• Target: 238
• Locations: 0 countries
• Sites: N/A

Brief Summary

This non-interventional study aims to validate the French version of a meningioma-specific quality-of-life questionnaire (MQOL-FR) and to describe health-related quality of life in adults diagnosed with an intracranial meningioma. Participants will be invited to complete online questionnaires through a secure REDCap link. After reading the study information and recording their non-opposition, participants will complete: (1) MQOL-FR (meningioma-specific), (2) EQ-5D-5L (generic health-related quality of life), and (3) FACT-Br (brain tumor-specific quality of life). The questionnaire session takes approximately 30-45 minutes and can be completed in more than one sitting using a REDCap access code. There is no additional visit and no change in usual care. The study will recruit adults (≥18 years) with a meningioma diagnosis based on imaging and/or confirmed by surgery, through the GHU Paris-Sainte-Anne neurosurgery clinic and through patient/community networks. The goal is to obtain 100 fully completed MQOL-FR questionnaires suitable for psychometric analyses.

Conditions

Intracranial Meningioma; Meningioma; Health-related Quality of Life

Keywords

meningioma; intracranial meningioma; quality of life; health-related quality of life; HRQoL; patient-reported outcomes; PRO; questionnaire validation; psychometric validation; MQOL; FACT-Br; EQ-5D-5L; REDCap; neurosurgery

Outcome Measures

Primary Outcomes (1)

• Meningioma Quality of Life Questionnaire - French version (MQOL-FR) : psychometric performance (structural validity, internal consistency, construct/convergent validity, completeness, floor/ceiling effects)

  The MQOL-FR is the French translation of the Meningioma Quality of Life questionnaire (MQOL), a self-administered, meningioma-specific health-related quality-of-life instrument (70 items across 9 domains). Total score range: 0 to 100; higher scores indicate a better outcome (better quality of life).

  Single assessment at enrollment (one questionnaire session; participants may complete within up to 1 month after invitation).

Study Arms (1)

Meningioma cohort

Adults (≥18 years) with intracranial meningioma diagnosed on imaging and/or confirmed surgically. Participants complete a single online, self-administered questionnaire session via a secure REDCap link. There is no study-related treatment, no additional visit, and usual care is unchanged.

Other: Quality-of-life questionnaire administration

Interventions

Quality-of-life questionnaire administration OTHER

Single-session completion of patient-reported outcome questionnaires: MQOL-FR (meningioma-specific), EQ-5D-5L, and FACT-Br, administered online via REDCap (approximately 30-45 minutes; may be completed in multiple sittings).

Meningioma cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults with intracranial meningioma, recruited through three sources to maximize heterogeneity: (1) patients seen in consultation at GHU Paris-Sainte-Anne; (2) members of the AMAVEA patient association informed by email; and (3) patients proposed by partner teams after a call for participation within the French Society of Neurosurgery Neuro-Oncology Club and Skull Base Club, contacted by email and invited to complete online questionnaires via REDCap.

You may qualify if:

• Age ≥ 18 years
• Diagnosis of intracranial meningioma on imaging and/or confirmed by surgery

You may not qualify if:

• Pregnant or breastfeeding
• Individuals deprived of liberty by judicial/administrative decision or under compulsory psychiatric care
• Insufficient French language proficiency/comprehension
• Unable to complete the questionnaires independently
• Unable to express non-opposition to participation

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

MeSH Terms

Conditions

Meningioma

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

Central Study Contacts

Viviane AWASSI

CONTACT

0145658486; 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: January 22, 2026
• First Posted: January 29, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 2, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01