Workshops and Exchange Groups for Laryngectomized Patients

NCT06077643 | Recruiting

• 1 other identifier: APHP230743
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngectomy; Status; Laryngeal Cancer

Keywords

Laryngectomy

Outcome Measures

Primary Outcomes (1)

• Differences in quality of life scores before and after the program, between the program and non-program control groups.

  The aim is to show a difference in patients' overall quality of life scores via the WHOQOL-BREF questionnaire, before and after the program.

  4 months

Secondary Outcomes (3)

• For overall quality of life using the WHOQOL-BREF questionnaire, comparison of the average patient scores, before and after exchange groups.

  4 months

• For ENT-specific quality of life using the EORTC QLQH&n43 questionnaire, comparison of the average patient scores, before and after exchange groups.

  4 months

• Evaluation of the participation rate (number of patients present out of the number of patients enrolled), during each session via the OVET software.

  4 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who has benefited from a total laryngectomy in the ENT department of Bichat Hospital or Georges Pompidou European Hospital, less than four years ago.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat - Claude Bernard Hospital

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Angèle Germon

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angèle Germon

CONTACT

06.40.65.58.75; angele.germon@aphp.fr

Diane Evrard, MD

CONTACT

01.40.25.77.14; diane.evrard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)