FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE (PETAL2)

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Total Laryngectomy and Their Close Relatives
• Intervention / Treatment: Other: PETAL program

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel PH BABIN; Phone Number: +33231064866; Email: babin-e@chu-caen.fr
• Study Contact Backup: Name: François FOURNEL; Phone Number: +33231065488; Email: fournel-f@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • CHU Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PETAL program; Patients with total laryngectomy and their close relatives, benefiting from the therapeutic education program PETAL	Other: 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.
No Intervention: Usual care; Patients with total laryngectomy and their close relatives, benefiting from the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score (PSS-HN scale) of patients with total laryngectomy	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score (EVA scale) of patient's close relatives	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.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 19-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No