Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas (MenQOL 2)

January 30, 2026 updated by: Centre Hospitalier St Anne

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Meningiomas are common intracranial tumors and may substantially affect psychological, social, and functional well-being, including in patients managed conservatively. However, validated meningioma-specific quality-of-life tools are limited. The MQOL questionnaire was originally developed as a patient-centered, meningioma-specific instrument; a prior French translation/adaptation and pilot evaluation has been conducted. This study (MenQOL2) is designed to complete an in-depth psychometric validation of the French version (MQOL-FR) in a larger cohort and to provide a descriptive assessment of quality of life in French patients with meningioma.

This is a single-center, non-interventional, questionnaire-based study with a single assessment (no follow-up). Adults (≥18 years) with intracranial meningioma diagnosed on imaging and/or confirmed surgically will be invited. Exclusion criteria include inability to complete questionnaires independently, insufficient French comprehension, pregnancy/breastfeeding, legal deprivation of liberty, and individuals under compulsory psychiatric care.

Participants receive study information (in clinic when applicable, otherwise by email) and access a secure REDCap link. Non-opposition is recorded online prior to questionnaire completion. Participants complete MQOL-FR (70 items), EQ-5D-5L, and FACT-Br. The total completion time is estimated at 30-45 minutes; completion may be split into multiple sessions using a REDCap-provided access code. Data are collected directly in REDCap and stored in pseudonymized form.

Primary outcome is psychometric performance of MQOL-FR, including dimensionality/structural validity, internal consistency (e.g., Cronbach's alpha), construct and convergent validity against EQ-5D-5L and FACT-Br, completeness rates, and floor/ceiling effects. Secondary objectives are descriptive and exploratory: to summarize MQOL-FR, EQ-5D-5L, and FACT-Br scores in the overall cohort and compare subgroups (e.g., WHO grade, sporadic vs progestin-associated, symptomatic vs asymptomatic, skull base vs convexity, tumor size, single vs multiple lesions, and management strategy). Exploratory modeling (ANCOVA/regression) will be used to assess factors associated with MQOL-FR scores. The targeted analyzable sample is 100 complete MQOL-FR responses; based on prior completion rates, approximately 238 patients will be contacted to achieve this target. In accordance with the collaboration with the original MQOL developers, de-identified score data may be shared for scientific purposes.

Study Type

Observational

Enrollment (Estimated)

238

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria :

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meningioma Quality of Life Questionnaire - French version (MQOL-FR) : psychometric performance (structural validity, internal consistency, construct/convergent validity, completeness, floor/ceiling effects)
Time Frame: Single assessment at enrollment (one questionnaire session; participants may complete within up to 1 month after invitation).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier St Anne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 2, 2026

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

September 2, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D25-P039

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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