Quality of Life in Patients After Pharyngolaryngectomy

Laryngectomy; Status Clinical Trial

— LARYNG-QDV  

Official title:

Quality of Life in Patients After Pharyngolaryngectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157555
• Other study ID #: 2021-010-LARYNG-QDV
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2021
• Source: Université de Reims Champagne-Ardenne
• Contact: Delphine DORMOIS, IPA
• Phone: 0326918822
• Email: delphine.dormois[@]etudiant.univ-reims.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.

Description:

The aim of the study is to describe quality of life in patients with laryngectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male or female

• with laryngectomy

• agreeing to participate in the study

Exclusion Criteria:

• less than 18 years old

Related Conditions & MeSH terms

• Laryngectomy; Status

Intervention

Other:
• Data collection
Description: quality of life assessment

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ-C30	The QLQ-C30 is a generic questionnaire with 30 questions coded in 4 response modalities (not at all (1), a little (2), enough (3), a lot (4)) or in 7 response modalities (from very bad (1) to excellent ( 7)).; Questions are summarized in five multiitem domains (physical, role, cognitive, emotional, and social functioning) and nine single item domains (fatigue, pain, nausea/vomiting, appetite loss, financial impact; diarrhea, constipation, sleep disturbance and quality of life).; Each domain is scored between 0 and 100. For functional domains, a high score value represents a high level of quality of life. For symptom domains, a high score represents an important level of symptoms (a low level of quality of life).	Day 0