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

NCT ID: NCT04569500

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-24
• Study Completion Date: 2027-12-30

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 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

Patients With Total Laryngectomy and Their Close Relatives

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PETAL program

Patients with total laryngectomy and their close relatives, benefiting from the therapeutic education program PETAL

Group Type: EXPERIMENTAL

PETAL program

Intervention Type: OTHER

patients and their close relations will benefit from the therapeutic education program PETAL in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life.

Usual care

Patients with total laryngectomy and their close relatives, benefiting from the usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PETAL program

patients and their close relations will benefit from the therapeutic education program PETAL in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Caen

Caen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emmanuel PH BABIN

Role: CONTACT

babin-e@chu-caen.fr

+33231064866

François FOURNEL

Role: CONTACT

fournel-f@chu-caen.fr

+33231065488

Other Identifiers

19-133

Identifier Type: -

Identifier Source: org_study_id