Laryngectomy; StatusGELATNCT06077643
Workshops and Exchange Groups for Laryngectomized Patients
An observational study of Laryngectomy; Status and Laryngeal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy; Status, Laryngeal Cancer
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2023to 10 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Bichat - Claude Bernard Hospital
Paris, 75018
Angèle Germon, 06.40.65.58.75, angele.germon@aphp.fr
About this study
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.
Read the detailed description
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:
- loss of phonation (voice) and need to learn to speak again through speech therapy;
- Disappearance of oral-nasal breathing (and therefore loss of smell, or even taste);
- Disappearance of the capacity of the effort with closed glottis (used in the acts of daily life: defecation, sexual act in men, etc.);
- Impairment of body image and sometimes self-esteem.
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:
- 1st: presentation of each, answers to questions;
- 2nd: intervention of the association of the mutilated of the voice;
- 3rd: questions / answers with a resource patient (laryngectomized for 13 years in Bichat);
- 4th: grouping of all participants to assess patient satisfaction.
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.
- Conditions
- Laryngectomy; Status, Laryngeal Cancer
- Keywords
- Laryngectomy
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 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.
The aim is to show a difference in quality of life scores specific to ENT EORTC QLQH\&n43, before and after the program.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start10 Oct 2023
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngectomy; StatusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angèle Germon, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077643
- Sponsor's protocol ID
- APHP230743
- Acronym
- GELAT
- Status last verified
- Mar 2026
- First submitted
- 5 Oct 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workshops and Exchange Groups for Laryngectomized Patients
- ClinicalTrials.gov ID
- NCT06077643
- Acronym / sponsor ID
- GELAT / APHP230743
- Conditions
- Laryngectomy; Status, Laryngeal Cancer
- Keywords
- Laryngectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- loss of phonation (voice) and need to learn to speak again through speech therapy;
- Disappearance of oral-nasal breathing (and therefore loss of smell, or even taste);
- Disappearance of the capacity of the effort with closed glottis (used in the acts of daily life: defecation, sexual act in men, etc.);
- Impairment of body image and sometimes self-esteem.
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:
- 1st: presentation of each, answers to questions;
- 2nd: intervention of the association of the mutilated of the voice;
- 3rd: questions / answers with a resource patient (laryngectomized for 13 years in Bichat);
- 4th: grouping of all participants to assess patient satisfaction.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in quality of life scores before and after the program, between the program and non-program control groups.
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.
3 secondary outcomes
For overall quality of life using the WHOQOL-BREF questionnaire, comparison of the average patient scores, before and after exchange groups.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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RecruitingObservational study
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
Speech Disorders, Speech Dysfunction
RecruitingPhase 2
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angèle Germon principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngectomy; Status and Laryngeal Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angèle Germon (06.40.65.58.75, angele.germon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in quality of life scores before and after the program, between the program and non-program control groups. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.