Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatment patient therapeutic education (pte) programme
Sponsor University Hospital, Caen
Collaborator University of Lille Nord de France
Start date April 2013
End date December 2017
Trial size 40 participants
Trial identifier NCT02903875, PHRC12-220

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
laryngectomised patients since 1 month and their close relative
patient therapeutic education (pte) programme
laryngectomised patients since 3 months and their close relative
patient therapeutic education (pte) programme
laryngectomised patients since 6 months and their close relative
patient therapeutic education (pte) programme
laryngectomised patients since 12 months and their close relative
patient therapeutic education (pte) programme

Primary Outcomes

Measure
interview of patient and close relatives
time frame: baseline

Secondary Outcomes

Measure
transferability of patient therapeutic education (PTE)
time frame: during 1 year
quality of patient therapeutic education (PTE)
time frame: during 1 year
quality of life (QLQC30)
time frame: baseline and 1 year after PTE

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Therapeutic Education Program Aimed at Improving the Quality of Life of Laryngectomised Patients and Their Close Relatives
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University Hospital, Caen.