Acoustic NeuromaPANQOLNCT04004377
Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised
An observational study of Acoustic Neuroma, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This study has investigated the quality of life of patients with vestibular schwannoma using this specific scale prospectively, whether treated surgically or monitored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acoustic Neuroma
- What is being tested?
- Scale of quality life
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2018to 5 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited during consultation ear (Multidisciplinary Consultative Meeting) , Neurosurgery of the University Hospital of Bordeaux - be in possession of an acoustic neuroma (or vestibular schwannoma) confirmed in MRI, unilateral, unoperated
Who may be able to join
- be in possession of an acoustic neuroma (or vestibular schwannoma) confirmed in MRI, unilateral, unoperated
- Age over 18 years
- patient insured or beneficiary of a social security scheme
- free, informed and express
Who cannot join
- History of surgery of the angle ponto-cerebellar or otologic
- Neurofibromatosis type 2
- Cons-indication to MRI
- psychiatric pathology
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital, Bordeaux
Bordeaux, 33000
Valérie FRANCO-VIDAL, MD, PhD, +335 56 79 55 42, valerie.vidal@chu-bordeaux.fr
Valérie FRANCO-VIDAL, MD,PhD
About this study
This study has investigated the quality of life of patients with vestibular schwannoma using this specific scale prospectively, whether treated surgically or monitored.
Read the detailed description
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a "normal" life, and the third assessing difficulties in working life.
The questionnaires are sent to the patient in the form of a custom web link generated on the online survey platform SurveyMonkey, and integrated into the body of an email sent from the mailbox of the investigator Hospital. There is any identifying or indirectly identifying data on the questionnaire online, guaranteeing protection of the rights of the individual. Only the principal investigator and co-investigator retain the link between the coded identity of persons undergoing research used to associate personal health data and their name (s) and name (s) (correspondence table retained securely to the paper).
- Conditions
- Acoustic Neuroma
- Being tested
- Scale of quality life
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scale of quality lifeOther
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a "normal" life, and the third assessing difficulties in working life.
| Study group | Role | What they receive |
|---|---|---|
| acoustic neuroma monitored radiologically | patient with an acoustic neuroma (vestibular schwannoma) with MRI confirmed, unilateral, not yet operated at baseline, aged over 18 years, monitoring by radiology Receives: Other: Scale of quality life | |
| acoustic neuroma whose treatment is surgical | patient with an acoustic neuroma (vestibular schwannoma or) with MRI confirmed, unilateral, not yet operated at baseline, aged over 18 years, resection surgery planified Receives: Other: Scale of quality life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of PANQUOL Questionnaire
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Measured: Month 1
Score of PANQUOL Questionnaire
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Measured: Month 3
Score of PANQUOL Questionnaire
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Measured: Month 6
Score of PANQUOL Questionnaire
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start5 Dec 2018
- Primary completion5 Dec 2020 (estimated)
- Study completion5 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acoustic NeuromaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie FRANCO-VIDAL, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004377
- Sponsor's protocol ID
- CHUBX 2018/39
- Acronym
- PANQOL
- Status last verified
- May 2019
- First submitted
- 28 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised
- ClinicalTrials.gov ID
- NCT04004377
- Acronym / sponsor ID
- PANQOL / CHUBX 2018/39
- Conditions
- Acoustic Neuroma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 5 Dec 2020 (estimated)
- Study completion
- 5 Dec 2020 (estimated)
- First posted
- 2 Jul 2019 (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.
This study has investigated the quality of life of patients with vestibular schwannoma using this specific scale prospectively, whether treated surgically or monitored.
Detailed description
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a "normal" life, and the third assessing difficulties in working life.
The questionnaires are sent to the patient in the form of a custom web link generated on the online survey platform SurveyMonkey, and integrated into the body of an email sent from the mailbox of the investigator Hospital. There is any identifying or indirectly identifying data on the questionnaire online, guaranteeing protection of the rights of the individual. Only the principal investigator and co-investigator retain the link between the coded identity of persons undergoing research used to associate personal health data and their name (s) and name (s) (correspondence table retained securely to the paper).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acoustic neuroma monitored radiologically | – | Other: Scale of quality lifepatient with an acoustic neuroma (vestibular schwannoma) with MRI confirmed, unilateral, not yet operated at baseline, aged over 18 years, monitoring by radiology |
| acoustic neuroma whose treatment is surgical | – | Other: Scale of quality lifepatient with an acoustic neuroma (vestibular schwannoma or) with MRI confirmed, unilateral, not yet operated at baseline, aged over 18 years, resection surgery planified |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited during consultation ear (Multidisciplinary Consultative Meeting) , Neurosurgery of the University Hospital of Bordeaux - be in possession of an acoustic neuroma (or vestibular schwannoma) confirmed in MRI, unilateral, unoperated
Key inclusion criteria (4 listed)
- be in possession of an acoustic neuroma (or vestibular schwannoma) confirmed in MRI, unilateral, unoperated
- Age over 18 years
- patient insured or beneficiary of a social security scheme
- free, informed and express
Key exclusion criteria (5 listed)
- History of surgery of the angle ponto-cerebellar or otologic
- Neurofibromatosis type 2
- Cons-indication to MRI
- psychiatric pathology
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Scale of quality lifeThe PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al. Three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a "normal" life, and the third assessing difficulties in working life. | Other | acoustic neuroma monitored radiologically, acoustic neuroma whose treatment is surgical |
Primary outcome
Score of PANQUOL Questionnaire
Time frame: Month 1
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Score of PANQUOL Questionnaire
Time frame: Month 3
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Score of PANQUOL Questionnaire
Time frame: Month 6
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Score of PANQUOL Questionnaire
Time frame: Month 12
The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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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. This study is not recruiting at the moment.
Valérie FRANCO-VIDAL, MD, PhD principal investigator
University Hospital, Bordeaux
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 Acoustic Neuroma, run by University Hospital, Bordeaux 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Severin BELLEUDY (+335 56 79 55 42, severin.belleudy@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of PANQUOL Questionnaire (time frame: Month 1). The study lists 4 primary outcomes in all. 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 2 Jul 2019.