NCT04569500 FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE
| NCT ID | NCT04569500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Patients With Total Laryngectomy and Their Close Relatives |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2021-09-24 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 264 participants in total. It began in 2021-09-24 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology (Pérol2007), in particular for cancers of the upper aerodigestive tract (Allison2010). 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: phonatory (loss of physiological voice), feeding, olfactory and aesthetic (tracheostomy). 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. Indeed, transformation is not only at individual level, it also impacts the life of close relations, in particular spouses, who share the day-to-day lives of patients (Babin 2010). Currently, care for laryngectomized patients consist essentially in informing and educating them on certain technical procedures (cannula replacement, mucosity aspiration, tracheostomy or phonatory implant cleaning) during hospital admission. Such education may be formalized and dispensed within the context of a therapeutic education program. The issue of this study will be to determine what therapeutic education program we should offer patients and their close relations in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life.
Eligibility Criteria
Patient inclusion criteria * Patients over 18 having been treated by total laryngectomy for cancer of the larynx, pharynx or cervical esophagus. * Patients accepting to participate in the study (informed consent form explained and signed). * Patient having not been undergone a PTE * Person affiliated with an appropriate social security system. Close relation inclusion criteria * Person over 18 designated as being a close relation by the laryngectomized patient (confidential person, spouse, parent, natural support person or any person whose quality of life may be impacted by the patient's laryngectomy). * Close relation accepting to participate in the study (informed consent form explained and signed). * Person authorized by the patient to be contacted by the investigator, in order to propose his/her participation in the research study. * Person affiliated with an appropriate social security system. Patient exclusion criteria - Physical, psychical, psychiatric or cognitive incapacity to answer to questions or participate in interviews/sessions. Close relation exclusion criteria \- Physical, psychical, psychiatric or cognitive incapacity to answer to questions or participate in interviews/sessions.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04569500 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patients With Total Laryngectomy and Their Close Relatives. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04569500 currently recruiting?
Yes, NCT04569500 is actively recruiting participants. Contact the research team at babin-e@chu-caen.fr for enrollment information.
Where is the NCT04569500 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT04569500 clinical trial?
NCT04569500 is sponsored by University Hospital, Caen. The trial plans to enroll 264 participants.