Head and Neck Cancer Clinical Trial
Official title:
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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