Quality of Life in Patients After Pharyngolaryngectomy

• Conditions: Laryngectomy; Status
• Interventions: Other: Data collection

• Registration Number: NCT05157555
• Lead Sponsor: Université de Reims Champagne-Ardenne

Brief 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.

Detailed Description

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

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-15
• Study Start: 2022-02-10
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-25
• Primary Completion: 2022-05-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• male or female
• with laryngectomy
• agreeing to participate in the study

Exclusion Criteria

• less than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
"with laryngectomy" group	Data collection	"with laryngectomy" group: patients with laryngectomy for any type of cancer

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-C30	Day 0	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).

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France