Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

Completed

• Conditions: Larynx Cancer; Pharyngeal Cancer; Swallowing Disorder

• Registration Number: NCT05497947
• Lead Sponsor: Centre Hospitalier de Valence

Brief Summary

A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

Detailed Description

the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language.

The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.

Study Timeline

• Study Start: 2021-07-03
• Primary Completion: 2022-07-05
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-11
• Study Completion: 2023-07-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Total PharyngoLaryngectomy
• Age ≥ 18 years old
• Read, write and understand the French language

Exclusion Criteria

• Patient under guardianship, deprived of liberty, safeguard of justice
• Refusal to participate in research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SOAL- VF	up to 6 months	Patient reported outcome measure

Trial Locations

Locations (1)

Ch Valence; 🇫🇷 Valence, Drome, France