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

Acoustic Neuroma Clinical Trial

— PANQOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004377
• Other study ID #: CHUBX 2018/39
• Status: Recruiting
• Start date: December 5, 2018
• Est. completion date: December 5, 2020

Study information

• Verified date: May 2019
• Source: University Hospital, Bordeaux
• Contact: Severin BELLEUDY
• Phone: +335 56 79 55 42
• Email: severin.belleudy[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 5, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acoustic Neuroma
• Neuroma
• Neuroma, Acoustic

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.

Locations

Country	Name	City	State
France	University Hospital, Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 1
Primary	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.	Month 3
Primary	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.	Month 6
Primary	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.	Month 12