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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| For overall quality of life using the WHOQOL-BREF questionnaire, comparison of the average patient scores, before and after exchange 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 |
| For ENT-specific quality of life using the EORTC QLQH&n43 questionnaire, comparison of the average patient scores, before and after exchange groups. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Angèle Germon | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bichat - Claude Bernard Hospital | Recruiting | Paris | 75018 | France |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The aim is to show a difference in quality of life scores specific to ENT EORTC QLQH&n43, before and after the program. |
| 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 |
| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |