NCT06077643 Workshops and Exchange Groups for Laryngectomized Patients
| NCT ID | NCT06077643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Laryngectomy; Status |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2026-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-10-10 with a primary completion date of 2026-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * Patient who has communicated an objection to their inclusion, after informed information.
Contact & Investigator
Angèle Germon
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06077643 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Laryngectomy; Status. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06077643 currently recruiting?
Yes, NCT06077643 is actively recruiting participants. Contact the research team at angele.germon@aphp.fr for enrollment information.
Where is the NCT06077643 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06077643 clinical trial?
NCT06077643 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Angèle Germon at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 50 participants.