Quality of Life in Patients After Pharyngolaryngectomy (LARYNG-QDV)

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.

Study Overview

• Status: Recruiting
• Conditions: Laryngectomy; Status
• Intervention / Treatment: Other: Data collection

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Delphine DORMOIS, IPA; Phone Number: +33 0326918822; Email: delphine.dormois@etudiant.univ-reims.fr

Study Locations

• France
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with laryngectomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

- less than 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"with laryngectomy" group; "with laryngectomy" group: patients with laryngectomy for any type of cancer	Other: Data collection; Description: quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Laryngeal cancer - laryngectomy - quality of life
• Other Study ID Numbers: 2021-010-LARYNG-QDV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No