Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Therapeutic education program to improve life for people after total laryngectomy and their caregivers

Official title: FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE

Run by University Hospital, Caen · NCT04569500 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment264 (estimated)
SponsorUniversity Hospital, Caen
Academic / other
Locations1 site (Caen)
StatusRecruiting
StartedSeptember 24, 2021
Main results expectedDecember 30, 2026
Study endsDecember 30, 2027
Registry record updatedJuly 25, 2025
Trial IDNCT04569500 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • CHU Caen
    Caen, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.