Bichat - Claude Bernard Hospital
Paris, 75018, France
Location status: Recruiting
NCT Number: NCT06077643
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75018, France
Location status: Recruiting
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:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 months
The aim is to show a difference in patients' overall quality of life scores via the WHOQOL-BREF questionnaire, before and after the program.
Time frame: 4 months
The aim is to show a difference in patients' overall quality of life scores via the WHOQOL-BREF questionnaire, before and after the program.
Time frame: 4 months
The aim is to show a difference in quality of life scores specific to ENT EORTC QLQH&n43, before and after the program.
Time frame: 4 months
Contact information is provided by the study sponsor or research team.
Angèle Germon
CONTACT
Diane Evrard, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: GELAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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