Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04569500

FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE

Led by University Hospital, Caen · Updated on 2025-07-25

264

Participants Needed

1

Research Sites

326 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 patient's 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.

CONDITIONS

Official Title

FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 having been treated by total laryngectomy for cancer of the larynx, pharynx or cervical esophagus.
  • Patients accepting to participate in the study (informed consent form explained and signed).
  • Patient having not been undergone a PTE.
  • Person affiliated with an appropriate social security system.
  • Person over 18 designated as being a close relation by the laryngectomized patient (confidential person, spouse, parent, natural support person or any person whose quality of life may be impacted by the patient's laryngectomy).
  • Close relation accepting to participate in the study (informed consent form explained and signed).
  • Person authorized by the patient to be contacted by the investigator, in order to propose his/her participation in the research study.
  • Person affiliated with an appropriate social security system.
Not Eligible

You will not qualify if you...

  • Physical, psychical, psychiatric or cognitive incapacity to answer to questions or participate in interviews/sessions for patients.
  • Physical, psychical, psychiatric or cognitive incapacity to answer to questions or participate in interviews/sessions for close relations.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHU Caen

Caen, France

Actively Recruiting

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Research Team

E

Emmanuel PH BABIN

CONTACT

F

François FOURNEL

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE | DecenTrialz