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

August 28, 2023 updated by: Centre Hospitalier de Valence
A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Drome
      • Valence, Drome, France, 26953
        • Ch Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients treated by Total PharyngoLaryngectomy in CH Valence

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOAL- VF
Time Frame: up to 6 months
Patient reported outcome measure
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Valence

Investigators

  • Principal Investigator: Guillaume BUIRET, MD, Ch Valence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2021

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 3, 2023

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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