Therapeutic education program to improve life for people after total laryngectomy and their caregivers
FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE
This program will see if the PETAL education sessions help adults who had a total laryngectomy and their close relatives improve daily functioning and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Trial ID | NCT04569500 on ClinicalTrials.gov |
What this trial studies
The PETAL program delivers structured therapeutic education to adults who have undergone total laryngectomy and to a close relative or caregiver. Sessions address the physical and functional consequences of laryngectomy (voice loss, swallowing, smell, tracheostomy care) as well as psychosocial and identity-related impacts on patients and families. Participants are enrolled at CHU Caen after informed consent and receive the education intervention with outcomes measured using quality-of-life and caregiver impact instruments. The intervention is non-pharmacologic and aims to build practical skills, coping strategies, and social support for both patients and their close relations.
Who should consider this trial
Good fit: Adults (≥18) who have undergone total laryngectomy for laryngeal, pharyngeal, or cervical esophageal cancer, can give informed consent, have not had a PTE, and can nominate a willing close relative are ideal candidates.
Not a fit: Patients with severe physical, psychiatric, or cognitive impairment that prevents participation, or those without an available close relative, are unlikely to benefit from this education program.
Why it matters
Potential benefit: If successful, the program could improve patients' daily functioning and emotional well-being while reducing caregiver burden.
How similar studies have performed: Educational and psychosocial programs for head and neck cancer patients and caregivers have shown improvements in quality of life in prior research, though the PETAL program is a novel, locally developed approach in France.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Caen
- CHU Caen — Caen, France (Recruiting)
Study contacts
- Study coordinator: Emmanuel PH BABIN
- Email: babin-e@chu-caen.fr
- Phone: +33231064866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.