Clinical trial NCT02903875: Therapeutic Education Program for Laryngectomised Patients and Their Close Relations
Official title: Therapeutic Education Program Aimed at Improving the Quality of Life of Laryngectomised Patients and Their Close Relatives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: University of Lille Nord de France
name: CERFEP CARSAT Nord-Picardie
name: INSERM U1086 Cancers et Préventions
First posted: 2016-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer of the larynx, pharynx or cervical esophagus treated with total laryngectomy and their relatives

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: interview of patient and close relatives
timeFrame: baseline
Secondary outcomes:
measure: transferability of patient therapeutic education (PTE)
timeFrame: during 1 year
measure: quality of patient therapeutic education (PTE)
timeFrame: during 1 year
measure: quality of life (QLQC30)
timeFrame: baseline and 1 year after PTE
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen Cancer Institute
city: Caen
country: France
facility: Caen University Hospital
city: Lille
country: France
facility: Lille Cancer Institute
city: Lille
country: France
facility: Lille University Hospital
Study officials:
References: