Therapeutic Education Program for Laryngectomised Patients and Their Close Relations (PETAL)

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

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Patient therapeutic education (PTE) programme

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Caen University Hospital
  • Caen, France
    • Caen Cancer Institute
  • Lille, France
    • Lille University Hospital
  • Lille, France
    • Lille Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer of the larynx, pharynx or cervical esophagus treated with total laryngectomy and their relatives

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laryngectomised patients since 1 month; laryngectomised patients since 1 month and their close relative	Other: Patient therapeutic education (PTE) programme
laryngectomised patients since 3 months; laryngectomised patients since 3 months and their close relative	Other: Patient therapeutic education (PTE) programme
laryngectomised patients since 6 months; laryngectomised patients since 6 months and their close relative	Other: Patient therapeutic education (PTE) programme
laryngectomised patients since 12 months; laryngectomised patients since 12 months and their close relative	Other: Patient therapeutic education (PTE) programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transferability of patient therapeutic education (PTE)	evaluating the programme's transferability in three centres	during 1 year
quality of patient therapeutic education (PTE)	evaluating the programme's quality in three centres	during 1 year
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: University of Lille Nord de France; CERFEP CARSAT Nord-Picardie; INSERM U1086 Cancers et Préventions

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: PHRC12-220

Plan for Individual participant data (IPD)

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