Quality of LifeMenQOLNCT07044076
Translation and Validation of the MQOL Self-questionnaire Into French for Assessing Quality of Life in Patients With Meningiomas
An observational study of Quality of Life and Meningioma, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Meningiomas, which account for about 40% of primary central nervous system tumors, have significant psychological and social impacts, even without treatment. Their effect on quality of life is often underestimated and poorly documented. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Meningioma
- What is being tested?
- Quality of life
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2025to 12 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of three groups to ensure maximum heterogeneity: 1. The study will be announced to all patients seen in consultation for meningioma at GHU Paris - Sainte-Anne (France). 2. All patients who are members of the AMAVEA association will be notified of the study by email. 3. Any patient referred by partner teams following a call for participation within the Neuro-Oncology Club and the Skull Base Club of the French Neurosurgery Society, recruited under the same procedure as the AMAVEA association.
Who may be able to join
- Patient aged 18 years or older
- Diagnosis of intracranial meningioma confirmed by imaging or surgery
Who cannot join
- Pregnant or breastfeeding women (Article L1121-5)
- Patients deprived of liberty by judicial or administrative decision, as well as individuals undergoing psychiatric care (Article L1121-6)
- Patients not fluent in French or with poor understanding of the language
- Inability to refuse participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Benoît HUDELIST, Dr contact
France1 site, 1 recruiting
- Recruiting
GHU Paris -Psychiatrie & Neurosciences
Paris, 15014
Johan PALLUD, Pr, J.PALLUD@ghu-paris.fr
About this study
Meningiomas, which account for about 40% of primary central nervous system tumors, have significant psychological and social impacts, even without treatment. Their effect on quality of life is often underestimated and poorly documented. There is one validated questionnaire (MQOL) but it has not yet been translated into French. The project involves two phases: first, translating and linguistically validating the MQOL into French; second, scientifically validating the questionnaire with 50 meningioma patients using established scales (EQ-5D, Karnofsky, FACT-Br) to ensure its reliability and internal consistency.
- Conditions
- Quality of Life, Meningioma
- Being tested
- Quality of life
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeOther
The four questionnaires (MQOL, EQ-5D, Karnofsky, and FACT-Br) will be sent to patients online using the secure online platform Redcap.
What is being measured
The primary outcome is the main question the study is designed to answer.
meningioma-specific quality-of-life questionnaire
The meningioma-specific quality-of-life questionnaire (MQOL) is an self-administered questionnaires and a validated tool used in practice in English, specifically applicable to patients with meningiomas, and was developed by a Canadian team (Baba A, Saha A, McCradden MD, Boparai K, Zhang S, Pirouzmand F, Edelstein K, Zadeh G, Cusimano MD. Development and validation of a patient-centered, meningioma-specific quality-of-life questionnaire. J Neurosurg. 2021 May 14;135(6):1685-1694. doi: 10.3171/2020.11.JNS201761. PMID: 33990085.)
This project will involve applying the MQOL to a population of 50 patients and comparing it with self-administered questionnaires already validated in French practice (FACT-Br, Karnofsky, and EQ-5D).
The purpose of all these questionnaires is to assess quality of life in patients.
The EQ-5D and Karnofsky evaluate it in a general manner, while the FACT-Br is used in an oncological context.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start13 Jun 2025
- Primary completion13 Jul 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044076
- Sponsor's protocol ID
- D25 - P003
- Acronym
- MenQOL
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the MQOL Self-questionnaire Into French for Assessing Quality of Life in Patients With Meningiomas
- ClinicalTrials.gov ID
- NCT07044076
- Acronym / sponsor ID
- MenQOL / D25 - P003
- Conditions
- Quality of Life, Meningioma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 13 Jul 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Meningiomas, which account for about 40% of primary central nervous system tumors, have significant psychological and social impacts, even without treatment. Their effect on quality of life is often underestimated and poorly documented. There is one validated questionnaire (MQOL) but it has not yet been translated into French. The project involves two phases: first, translating and linguistically validating the MQOL into French; second, scientifically validating the questionnaire with 50 meningioma patients using established scales (EQ-5D, Karnofsky, FACT-Br) to ensure its reliability and internal consistency.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of three groups to ensure maximum heterogeneity: 1. The study will be announced to all patients seen in consultation for meningioma at GHU Paris - Sainte-Anne (France). 2. All patients who are members of the AMAVEA association will be notified of the study by email. 3. Any patient referred by partner teams following a call for participation within the Neuro-Oncology Club and the Skull Base Club of the French Neurosurgery Society, recruited under the same procedure as the AMAVEA association.
Key inclusion criteria (2 listed)
- Patient aged 18 years or older
- Diagnosis of intracranial meningioma confirmed by imaging or surgery
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women (Article L1121-5)
- Patients deprived of liberty by judicial or administrative decision, as well as individuals undergoing psychiatric care (Article L1121-6)
- Patients not fluent in French or with poor understanding of the language
- Inability to refuse participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of lifeThe four questionnaires (MQOL, EQ-5D, Karnofsky, and FACT-Br) will be sent to patients online using the secure online platform Redcap. | Other | – |
Primary outcome
meningioma-specific quality-of-life questionnaire
Time frame: 1 month
The meningioma-specific quality-of-life questionnaire (MQOL) is an self-administered questionnaires and a validated tool used in practice in English, specifically applicable to patients with meningiomas, and was developed by a Canadian team (Baba A, Saha A, McCradden MD, Boparai K, Zhang S, Pirouzmand F, Edelstein K, Zadeh G, Cusimano MD. Development and validation of a patient-centered, meningioma-specific quality-of-life questionnaire. J Neurosurg. 2021 May 14;135(6):1685-1694. doi: 10.3171/2020.11.JNS201761. PMID: 33990085.) This project will involve applying the MQOL to a population of 50 patients and comparing it with self-administered questionnaires already validated in French practice (FACT-Br, Karnofsky, and EQ-5D). The purpose of all these questionnaires is to assess quality of life in patients. The EQ-5D and Karnofsky evaluate it in a general manner, while the FACT-Br is used in an oncological context.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benoît HUDELIST, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Meningioma, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane AWASSI (01.45.65.84.86, v.awassi@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meningioma-specific quality-of-life questionnaire (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.