Clinical trial NCT04004377: Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised
Official title: Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acoustic Neuroma
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of surgery of the angle ponto-cerebellar or otologic
* Neurofibromatosis type 2
* Cons-indication to MRI
* psychiatric pathology
* Pregnant or breastfeeding women

Primary outcomes:
measure: Score of PANQUOL Questionnaire
timeFrame: Month 1
measure: Score of PANQUOL Questionnaire
timeFrame: Month 3
measure: Score of PANQUOL Questionnaire
timeFrame: Month 6
measure: Score of PANQUOL Questionnaire
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Valérie FRANCO-VIDAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: