Evaluation of the French Translation of Swallowing (SOAL-... | NCT05497947

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

NCT05497947

Sponsor

Centre Hospitalier de Valence

Status

Completed

Last Update Posted

Sep 8, 2025Actual

Enrollment

225Actual

Phase

Not provided

Conditions

Pharyngeal Cancer
Swallowing Disorder
Larynx Cancer

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2021Actual

Primary Completion Date

Jul 5, 2022Actual

Completion Date

Jul 3, 2023Actual

First Submitted Date

Aug 10, 2022

First Submission Date that Met QC Criteria

Aug 10, 2022

First Posted Date

Aug 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2025

Last Update Posted Date

Sep 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

225Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients treated by Total PharyngoLaryngectomy in CH Valence

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillaume BUIRET, MD	CH VALENCE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ch Valence		Valence	Drome	26953	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010610	Pharyngeal Neoplasms
D003680	Deglutition Disorders
D007822	Laryngeal Neoplasms

Ancestor Terms

ID	Term
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided