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

Not Applicable

• Conditions: Patients With Total Laryngectomy and Their Close Relatives
• Interventions: Other: PETAL program

• Registration Number: NCT04569500
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28
• Study Start: 2021-09
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quality of life score (PSS-HN scale) of patients with total laryngectomy	12 months	Difference in gain observed at six months in the mean quality of life score (PSS-HN scale) of patients with total laryngectomy and their close relatives, having benefited from the PTE program and those having benefited from usual care.

Secondary Outcome Measures

Name	Time	Method
Quality of life score (EVA scale) of patient's close relatives	12 months	difference in gain observed at six months in the mean quality of life score (EVA scale) between close relations having benefited from the PTE program and those having benefited from usual support.