Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Acoustic Neuroma Other: Scale of quality life

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Acoustic Neuroma: Assessing the Quality of Life by the Scale PANQOL of Patients Operated or Supervised
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 5, 2020
Estimated Study Completion Date : December 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acoustic Neuroma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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

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.
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

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004377


Contacts
Layout table for location contacts
Contact: Severin BELLEUDY +335 56 79 55 42 severin.belleudy@chu-bordeaux.fr

Locations
Layout table for location information
France
University Hospital, Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Valérie FRANCO-VIDAL, MD, PhD    +335 56 79 55 42    valerie.vidal@chu-bordeaux.fr   
Principal Investigator: Valérie FRANCO-VIDAL, MD,PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Layout table for investigator information
Principal Investigator: Valérie FRANCO-VIDAL, MD, PhD University Hospital, Bordeaux
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04004377    
Other Study ID Numbers: CHUBX 2018/39
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroma
Neuroma, Acoustic
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Cranial Nerve Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases