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

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ClinicalTrials.gov Identifier: NCT04004377
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date June 28, 2019
First Posted Date July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date December 5, 2018
Estimated Primary Completion Date December 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Acoustic Neuroma
Intervention Other: Scale 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.

Study Groups/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
    Intervention: 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
    Intervention: Other: Scale of quality life
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 28, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 5, 2020
Estimated Primary Completion Date December 5, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Severin BELLEUDY +335 56 79 55 42 severin.belleudy@chu-bordeaux.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04004377
Other Study ID Numbers CHUBX 2018/39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
Principal Investigator: Valérie FRANCO-VIDAL, MD, PhD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date May 2019