Workshops and Exchange Groups for Laryngectomized Patients — GELAT  

Laryngeal Cancer Clinical Trial

Official title: Workshops and Exchange Groups for Laryngectomized Patients

Status Recruiting

Clinical Trial Summary

This research is conducted with the aim of improving the quality of life of laryngectomized patients and their entourage. Worldwide, there are 185,000 new cases of laryngeal cancer per year. In Europe, between 2000 and 2007, the crude annual incidence rates of these cancers were 4.6/100,000 with a 5-year survival rate of 61%.

In France, about 30 to 35% of cancers of the upper aerodigestive tract are localized to the larynx, or about 43,000 cases per year. Most patients are men (89%) between 50 and 70 years old. One of the treatments for these cancers is to perform an excision of the larynx thus removing the entire tumor, it is the total laryngectomy. The trachea is thus permanently removed from the skin and the digestive tract becomes independent.

Clinical Trial Description

In the ENT department of Bichat Hospital, there is an average of fourteen surgeries of this type per year, over the last three years. The direct consequences of total laryngectomy are multiple:

• loss of phonation (voice) and need to learn to speak again through speech therapy;

• Disappearance of oral-nasal breathing (and therefore loss of smell, or even taste);

• Disappearance of the capacity of the effort with closed glottis (used in the acts of daily life: defecation, sexual act in men, etc.);

• Impairment of body image and sometimes self-esteem.

For these reasons, it is essential to accompany patients post-operative to help them understand their body image and mitigate the direct and indirect consequences of this intervention. There are very few organizations to assist these patients in this life change.

To support laryngectomized patients, the study will test and validate the creation of self-help and support groups. The study will include laryngectomized patients who wish and can participate in these groups.

The sessions will take place as follows:

• 1st: presentation of each, answers to questions;

• 2nd: intervention of the association of the mutilated of the voice;

• 3rd: questions / answers with a resource patient (laryngectomized for 13 years in Bichat);

• 4th: grouping of all participants to assess patient satisfaction.

To assess the benefit of these meetings, a global quality of life questionnaire (WHOQOL-BREF) and an ENT-specific questionnaire (EORTC QLQH&n43) will be given to patients before the first session and retrieved beforehand. The patient will be able to participate in the sessions only if the questionnaires are submitted. The questionnaires are accompanied by a free text part, so that the person fills in the keys that the workshops have brought him. Patients who cannot participate in the exchange groups for geographical or personal reasons will constitute a control group. They will also complete the two questionnaires four months apart. The number of patients registered and the participation rate at each session will be evaluated. ;

Related Conditions & MeSH terms

• Laryngeal Cancer
• Laryngeal Neoplasms
• Laryngectomy; Status

• NCT number: NCT06077643
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Angèle Germon
• Phone: 06.40.65.58.75
• Email: angele.germon@aphp.fr
• Status: Recruiting
• Start date: October 10, 2023
• Completion date: October 10, 2024