ClinicalTrials.gg
Status unknownNCT04004377PANQOLUpdated Jul 2, 2019

Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised

An observational study in Acoustic Neuroma, sponsored by University Hospital, Bordeaux. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by University Hospital, Bordeaux · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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 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).

02

Conditions studied

  • Acoustic Neuroma

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03

In context

Neuroma, Acoustic

98 studies on the registry are indexed under Neuroma, Acoustic; 27 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 25 observational studies indexed under Neuroma, Acoustic.

Browse Neuroma, Acoustic studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    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

    Other: Scale of quality life

Interventions

  • OtherScale of quality life

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: Month 1

  2. 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.

    Time frame: Month 3

  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.

    Time frame: Month 6

  4. 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.

    Time frame: Month 12

07

Study locations

1 of 1 sites recruiting
  • University Hospital, Bordeaux
    Bordeaux, 33000, France
    • Valérie FRANCO-VIDAL, MD, PhD · Contact · valerie.vidal@chu-bordeaux.fr · +335 56 79 55 42
    • Valérie FRANCO-VIDAL, MD,PhD · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04004377
Responsible party
Sponsor
First posted
Jul 2, 2019
Start date
Dec 5, 2018
Primary completion
Dec 5, 2020 (estimated)
Completion
Dec 5, 2020 (estimated)
Last update
Jul 2, 2019

Study contacts

Severin BELLEUDY
Contact
severin.belleudy@chu-bordeaux.fr
+335 56 79 55 42
Valérie FRANCO-VIDAL, MD, PhD
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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