Therapeutic Education Program for Laryngectomised Patients and Their Close Relations
PETAL
1 other identifier
observational
40
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 7, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedSeptember 16, 2016
September 1, 2016
4.7 years
September 7, 2016
September 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
transferability of patient therapeutic education (PTE)
during 1 year
quality of patient therapeutic education (PTE)
during 1 year
quality of life (QLQC30)
baseline and 1 year after PTE
Study Arms (4)
laryngectomised patients since 1 month
laryngectomised patients since 1 month and their close relative
laryngectomised patients since 3 months
laryngectomised patients since 3 months and their close relative
laryngectomised patients since 6 months
laryngectomised patients since 6 months and their close relative
laryngectomised patients since 12 months
laryngectomised patients since 12 months and their close relative
Interventions
Eligibility Criteria
Patients with cancer of the larynx, pharynx or cervical esophagus treated with total laryngectomy and their relatives
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Caenlead
- University of Lille Nord de Francecollaborator
- CERFEP CARSAT Nord-Picardiecollaborator
- INSERM U1086 Cancers et Préventionscollaborator
Study Sites (4)
Caen Cancer Institute
Caen, France
Caen University Hospital
Caen, France
Lille Cancer Institute
Lille, France
Lille University Hospital
Lille, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
September 16, 2016
Study Start
April 1, 2013
Primary Completion
December 1, 2017
Study Completion
July 1, 2018
Last Updated
September 16, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share