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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Caen
RECRUITING
Caen
Contact Information
Primary
Emmanuel PH BABIN
babin-e@chu-caen.fr
+33231064866
Backup
François FOURNEL
fournel-f@chu-caen.fr
+33231065488
Time Frame
Start Date: 2021-09-24
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 264
Treatments
Experimental: PETAL program
Patients with total laryngectomy and their close relatives, benefiting from the therapeutic education program PETAL
No_intervention: Usual care
Patients with total laryngectomy and their close relatives, benefiting from the usual care
Sponsors
Leads: University Hospital, Caen

This content was sourced from clinicaltrials.gov