Psychometric Validation of the MQOL-FR and Descriptive Assessment of Quality of Life in Patients With Meningiomas
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Quality-of-life questionnaire administration.
- Кому может быть актуально
- Состояния в реестре: Intracranial Meningioma, Meningioma, Health-related Quality of Life. Базовые параметры: 18 лет — 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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).
Первичные конечные точки
- Meningioma Quality of Life Questionnaire - French version (MQOL-FR) : psychometric performance (structural validity, internal consistency, construct/convergent validity, completeness, floor/ceiling effects) [Срок оценки: Single assessment at enrollment (one questionnaire session; participants may complete within up to 1 month after invitation).]
Критерии участия
Критерии включения
- Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of intracranial meningioma on imaging and/or confirmed by surgery
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07376473 · D25-P039