Patients With Total Laryngectomy and Their Close Relatives
Conditions
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.
Interventions
OTHERPETAL program
patients and their close relations will benefit from the therapeutic education program PETAL in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life.
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score (PSS-HN scale) of patients with total laryngectomy | 12 months | Difference in gain observed at six months in the mean quality of life score (PSS-HN scale) of patients with total laryngectomy and their close relatives, having benefited from the PTE program and those having benefited from usual care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score (EVA scale) of patient's close relatives | 12 months | difference in gain observed at six months in the mean quality of life score (EVA scale) between close relations having benefited from the PTE program and those having benefited from usual support. |
Countries
France
Contacts
Primary ContactEmmanuel PH BABIN
Backup ContactFrançois FOURNEL
Outcome results
None listed