Workshops and Exchange Groups for Laryngectomized Patients

NCT ID: NCT06077643

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2024-10-10

Brief 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.

Detailed 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.

Conditions

Laryngectomy; Status; Laryngeal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exchange group

Each patient will participate in a cycle of four sessions, over four months. Each will be carried out with five patients, in order to facilitate exchanges. The aim is to organize eight groups that will each complete a cycle. This will allow to include about forty patients in the study.

No interventions assigned to this group

Control group

Patients who don't want to participate in the exchange groups but agree to be included in the control group. They will have to complete the quality of life questionnaires four months apart.

Estimation of 10 patients included.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Have had a total laryngectomy at Bichat Hospital or HEGP within the last four years
• Have completed all the specific care of the pathology that required the total laryngectomy
• Be able to travel to Bichat Hospital for all four sessions
• Be over 18 years of age
• Have received informed information about the conduct of the research.

Exclusion Criteria

• WHO simplified autonomy scale greater than 2, i.e. from normal activity to ambulant and able to take care of themselves, but unable to provide work and bedridden for less than 50% of their time
• Patient who does not speak or understand French
• Lack of affiliation to a social security scheme or CMU
• Patient benefiting from legal protection measures (guardianship or curatorship)
• Patient who has communicated an objection to their inclusion, after informed information.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angèle Germon

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Bichat - Claude Bernard Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Angèle Germon

Role: CONTACT

angele.germon@aphp.fr

06.40.65.58.75

Diane Evrard, MD

Role: CONTACT

diane.evrard@aphp.fr

01.40.25.77.14

Facility Contacts

Angèle Germon

Role: primary

angele.germon@aphp.fr

06.40.65.58.75

Other Identifiers

APHP230743

Identifier Type: -

Identifier Source: org_study_id