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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCentre Hospitalier St Anne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Diagnosis of intracranial meningioma on imaging and/or confirmed by surgery

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Quality-of-life questionnaire administration

    Other intervention

    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).

Treatment groups

238 Participants
are divided into 1 treatment group
Group A: Meningioma cohort1 intervention

Trial outcomes

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).

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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