Actively Recruiting

Age: 18Years +
All Genders
ID06077643

Workshops and Exchange Groups for Laryngectomized Patients to Improve Quality of Life

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-27

50

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on improving the quality of life for patients who have undergone total laryngectomy, a surgical procedure that removes the larynx often performed to treat laryngeal cancer. Worldwide, there are about 185,000 new laryngeal cancer cases yearly, with significant numbers in Europe and France. The surgery results in permanent changes such as loss of voice, altered breathing, and effects on body image and self-esteem, making post-operative support essential. The study will test and validate self-help and support groups for laryngectomized patients. Groups of about five patients will participate in a cycle of four sessions over four months. These sessions include introductions, presentations by a voice loss association, discussions with an experienced laryngectomized patient, and a group satisfaction assessment. Patients unable to join the groups due to personal or geographic reasons will form a control group and complete quality of life questionnaires spaced four months apart. Participants will complete two quality of life questionnaires before and after the program to measure impact. The sessions and questionnaire responses will help assess benefits. Attendance rates will be tracked using software, and control group participants will also complete questionnaires four months apart. The total study duration for participants is approximately four months, focusing on measuring changes in quality of life scores between groups.

CONDITIONS

Brief Title

Workshops and Exchange Groups for Laryngectomized Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have had a total laryngectomy at Bichat Hospital or HEGP within the last four years
  • Have completed all specific care required after the laryngectomy
  • Be able to travel to Bichat Hospital for all four sessions
  • Be 18 years of age or older
  • Have received informed information about the research and agreed to participate
Not Eligible

You will not qualify if you...

  • Have a WHO simplified autonomy scale greater than 2 (limited activity or bedridden more than 50% of the time)
  • Do not speak or understand French
  • Lack affiliation to a social security scheme or CMU
  • Are under legal protection measures such as guardianship or curatorship
  • Have objected to inclusion after receiving informed information

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Exchange Group Sessions

Duration - 4 months

Participants attend a cycle of four group sessions over four months designed to support laryngectomized patients through presentations, resource patient interactions, and group discussions to improve quality of life.

4 group sessions (in-person, approximately monthly)

Control Group Observation

Duration - 4 months

Participants who do not join the exchange groups complete quality of life questionnaires four months apart to serve as a comparison group.

2 questionnaire completions (can be remote or in-person)

Trial Site Locations

Total: 1 location

1

Bichat - Claude Bernard Hospital

Paris, France, 75018

Actively Recruiting

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Research Team

A

Angèle Germon

D

Diane Evrard, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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