Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
ORL Cancer
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 45 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Single-centre prospective pilot study designed to demonstrate the acceptability of onco-sexology management for laryngectomy patients and their partners in order to improve their perception of their intimate life. This is a non-interventional study (category 3 Loi Jardé), which will not result in any change in patient management. All procedures will be carried out in accordance with standard practice.
Patients will be followed for 14 months.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
For patients:
1. Patient to be treated for ORL cancer by total (pharyngo)laryngectomy
2. Patient WHO 0-1-2
3. Age greater than or equal to 18 years
4. Patient who has not objected to participation in the study.
For partners (if applicable) :
1. Age greater than or equal to 18 years
2. Subject who has not objected to participation in the study.
Exclusion Criteria:
For patients:
1. Patient with another co-existing malignant disease at the time of inclusion.
2. Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
3. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
For partners (if applicable):
1\. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).
Población del estudio
Patients with cancer (ORL) treated by laryngectomy.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Patients with cancer (ORL) treated by laryngectomy
No informado en este registro.
Other: In this research, the procedure under study is represented:
In this research, the procedure under study is represented: OTHER
- On the one hand, by carrying out sexology consultations which consist of individual interviews with a qualified sexologist nurse.
- Secondly, questionnaires to assess quality of life and sexual function, to be completed by patients during standard follow-up consultations; and a questionnaire on satisfaction with sexological follow-up, to be completed by patients and their partners (if applicable) during the last standard follow-up consultation.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management.
Plazo: 14 months for each patient
This rate corresponds to the ratio of the number of patients meeting the acceptability criteria to the total number of patients included.
Acceptability is defined when the following two criteria are validated:
- Completion of onco-sexology consultations 2 and 3 (at 3 and 12 months after cancer treatment)
- Patient satisfaction ≥ 3 on a numerical scale from 1 to 5.
Medidas secundarias
For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire.
Plazo: 14 months for each patient
The score, which ranges from 0 to 100, is determined according to the algorithm published by the EORTC, based on answers to 8 questions. This is a self-administered questionnaire validated in French
For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire.
Plazo: 14 months for each patient
These are self-administered questionnaires validated in French.
For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm).
Plazo: 14 months for each patient
The FSFI (Female Sexual Function Index) is a self-administered questionnaire validated in French. It comprises 19 items studying 6 dimensions of female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm) which make up an overall score of between 2 and 36.
For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
Plazo: 14 months for each patient
The MSHQ (Male Sexual Health Questionnaire) is a self-questionnaire validated in French which assesses the ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction).
For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship.
Plazo: 14 months for each patient
It will be assessed using a descriptive analysis (marital status before and after cancer treatment, stability, strengthening or deterioration of the couple's relationship).
For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation.
Plazo: 14 months for each patient
It will be assessed using a Likert scale. This type of scale was developed to measure attitudes and opinions (Rensis Likert 'A Technique for the Measurement of Attitudes', Archives of Psychology, vol.140, 1932, p. 1-55).
For the partner: - The rate of partners verifying the acceptability criteria for onco-sexology management is defined by the ratio of the number of partners verifying the acceptability criteria to the total number of partners included.
Plazo: 14 months for each partner
The definition of acceptability is the same as for the primary endpoint.
For the partner: The impact of the (pharyngo)laryngectomy totale on the couple's relationship will be assessed using a descriptive analysis (stability, reinforcement or deterioration of the couple's life).
Plazo: 14 months for each partner
No informado en este registro.
For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale.
Plazo: 14 months for each partner
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
IUCT-OToulouse, FranceReclutando
Equipo y fechas
- Patrocinador principal
- Institut Claudius Regaud
- Inicio del estudio
- 30 jul 2024 Real
- Finalización primaria
- 30 sept 2030 Estimado
- Finalización del estudio
- 30 sept 2030 Estimado
- Primera publicación
- 24 jul 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026