Workshops and Exchange Groups for Laryngectomized Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsGroup A: Exchange group
Group B: Control group
Trial outcomes
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.
Time frame
4 monthsSecondary outcomes
1
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.
Time frame
4 months2
For ENT-specific quality of life using the EORTC QLQH&n43 questionnaire, comparison of the average patient scores, before and after exchange groups.
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 months3
Evaluation of the participation rate (number of patients present out of the number of patients enrolled), during each session via the OVET software.
Time frame
4 monthsSponsors and contacts
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Source ClinicalTrials.gov