Clinical trial NCT04569500: FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE
Official title: FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Total Laryngectomy and Their Close Relatives
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Patient 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.

Close relation inclusion criteria

* 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.

Patient exclusion criteria - Physical, psychical, psychiatric or cognitive incapacity to answer to questions or participate in interviews/sessions.

Close relation exclusion criteria

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

Primary outcomes:
measure: Quality of life score (PSS-HN scale) of patients with total laryngectomy
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life score (EVA scale) of patient's close relatives
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: