Viewing Study NCT04569500



Ignite Creation Date: 2024-05-06 @ 3:14 PM
Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04569500
Status: UNKNOWN
Last Update Posted: 2021-07-28
First Post: 2020-09-24

Brief Title: FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS AND THEIR FAMILY CAREGIVERS QUALITY OF LIFE
Sponsor: University Hospital Caen
Organization: University Hospital Caen

Study Overview

Official Title: FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS AND THEIR FAMILY CAREGIVERS QUALITY OF LIFE
Status: UNKNOWN
Status Verified Date: 2020-09
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PETAL2
Brief Summary: The therapeutic education of patients and their close relations is as yet poorly developed in France in the field of oncology Pérol2007 in particular for cancers of the upper aerodigestive tract Allison2010 In the case of pharyngeal and laryngeal cancer total laryngectomy associated with radiotherapy remains a reference treatment for advanced stage cancers This mutilating surgical procedure has a major impact on the patients life due to its physical and functional sequelae phonatory loss of physiological voice feeding olfactory and aesthetic tracheostomy Its psychosocial consequences are also important owing to the biographical disruption and the identity-related metamorphoses associated with illness and its treatment which alter the quality of life not only of patients but also of their close relations Indeed transformation is not only at individual level it also impacts the life of close relations in particular spouses who share the day-to-day lives of patients Babin 2010 Currently care for laryngectomized patients consist essentially in informing and educating them on certain technical procedures cannula replacement mucosity aspiration tracheostomy or phonatory implant cleaning during hospital admission Such education may be formalized and dispensed within the context of a therapeutic education program

The issue of this study will be to determine what therapeutic education program we should offer patients and their close relations in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None