Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality-of-life questionnaire administration.
- Who it may be relevant to
- Registry conditions: Intracranial Meningioma, Meningioma, Health-related Quality of Life. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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).
Primary outcome measures
- 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07376473 · D25-P039