Therapeutic Education Program for Laryngectomised Patients and Their Close Relations

Head and Neck Cancer Clinical Trial

— PETAL  

Official title:

Therapeutic Education Program Aimed at Improving the Quality of Life of Laryngectomised Patients and Their Close Relatives

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02903875
• Other study ID #: PHRC12-220
• Status: Active, not recruiting
• Phase: N/A
• First received: September 7, 2016
• Last updated: September 13, 2016
• Start date: April 2013
• Est. completion date: July 2018

Study information

• Verified date: September 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology, in particular for cancers of the upper aerodigestive tract. 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. 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. Currently, care for laryngectomised patients consists essentially in informing and educating them on certain technical procedures during hospital admission. New voice education can be a long process and often involves the intervention of a speech therapist, who serves as the link between the patient and the hospital care team. These healthcare modalities often insufficiently account for the social, environmental and personal factors that interact in health-related problems.

The aim is to design, implement and evaluate a patient therapeutic education (PTE) programme, for laryngectomised patients and their close relations, aimed at improving their quality of life.

The research will be conducted over three phases:

The first phase, referred to as the "pilot" phase, will include exploratory, observational and retrospective analysis aimed at developing knowledge on the consequences of laryngectomy on the quality of life of patients and their close relations, the strengths and weaknesses of current practice in patient support and the needs expressed by the players involved (patients, relations, professional carers). This analysis will be conducted via interviews with patients and their close relations and focus groups with the healthcare professionals involved in patient care and support (hospital and independent). This first phase will enable the pluridisciplinary design of a therapeutic education programme for laryngectomised patients and their close relations which will be tested in the study's principle coordinating centre. The method defined thus is in keeping with quality criteria set by the HAS specifying that the PTE should focus on the patient, be scientifically justified, and be developed by a pluridisciplinary group reuniting representatives of patients or patient associations.

The second phase, referred to as the prospective intervention "replication" phase, aims at evaluating the programme's transferability and quality in three centres. The centres participating in this second phase already have experience in the development of PTE programmes and will be involved in the workgroup entrusted with the design of the PETAL programme during phase 1.

The third phase, referred to as the "randomised" multicentric comparative intervention phase, should enable us to assess the benefits of the developed PTE programme on the quality of life of patients and their close relations.

This is a pluridisciplinary study via which we hope to improve the quality of life of laryngectomised patients and their close relations through the design and the sustainable deployment of an innovative PTE programme in France and Belgium. This project also aims at reinforcing town-hospital links to improve help, follow-up and support for patients and their close relations, as well as dialogue between healthcare professionals.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient (18-70 years) treated with total laryngectomy for cancer of the larynx, pharynx or cervical esophagus

• Patient agreeing to participate in the study (informed consent)

• Person designated as close relative by the laryngectoised patient (support person, spouse, parent, caregiver)

• Close relative agreeing to participate in the study (informed consent) after the patient himself has authorized the investigator to contact that person to offer to participate in the study

• Time since laryngectomy (group 1 : 1 month, group 2: 3 months, group 3: 6 months, group 4 : 12 months)

Exclusion Criteria:

• Physical , mental, cognitive or psychiatric disabilityof the patient to answer questions and participate in interviews and therapeutic education program

• Physical , mental, psychiatric or cognitive disability of the close relative to answer questions and participate in interviews and therapeutic education program

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Patient therapeutic education (PTE) programme

Locations

Country	Name	City	State
France	Caen Cancer Institute	Caen
France	Caen University Hospital	Caen
France	Lille Cancer Institute	Lille
France	Lille University Hospital	Lille

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Caen	CERFEP CARSAT Nord-Picardie, INSERM U1086 Cancers et Préventions, University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interview of patient and close relatives	design, implement and evaluate a patient therapeutic education (PTE) programme, for laryngectomised patients and their close relations, aimed at improving their quality of life.	baseline	No
Secondary	transferability of patient therapeutic education (PTE)	evaluating the programme's transferability in three centres	during 1 year	No
Secondary	quality of patient therapeutic education (PTE)	evaluating the programme's quality in three centres	during 1 year	No
Secondary	quality of life (QLQC30)	to assess the benefits of the developed PTE programme on the quality of life of patients and their close relations	baseline and 1 year after PTE	No