Идёт набор NCT06517355

Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners

— Наблюдательное ORL Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: In this research, the procedure under study is represented:.
Кому может быть актуально: Состояния в реестре: ORL Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Другое In this research, the procedure under study is represented:
* 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.

Первичные конечные точки

The primary endpoint is defined as the rate of patients meeting the acceptability criteria for onco-sexology management. [Срок оценки: 14 months for each patient]

Вторичные конечные точки (9)

For the patients: Patients' sexual satisfaction will be assessed using the specific scale of the EORTC QLQSHQ-C22 questionnaire. [Срок оценки: 14 months for each patient]
For the patients: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire and the disease-specific QLQ-H&N43 questionnaire. [Срок оценки: 14 months for each patient]
For the patients: The female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm). [Срок оценки: 14 months for each patient]
For the patients: The ability to have sexual intercourse by considering several domains (erections, ejaculations, desire and satisfaction). [Срок оценки: 14 months for each patient]
For the patients: The impact of (pharyngo)laryngectomy totale on the couple's relationship. [Срок оценки: 14 months for each patient]
For the patients: Satisfaction or dissatisfaction with the onco-sexology consultation. [Срок оценки: 14 months for each patient]
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. [Срок оценки: 14 months for each partner]
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). [Срок оценки: 14 months for each partner]
For the partner: Satisfaction or dissatisfaction with the onco-sexology consultation will be assessed using a Likert scale. [Срок оценки: 14 months for each partner]

Критерии участия

Критерии включения

For patients:

Patient to be treated for ORL cancer by total (pharyngo)laryngectomy
Patient WHO 0-1-2
Age greater than or equal to 18 years
Patient who has not objected to participation in the study.

For partners (if applicable) :

Age greater than or equal to 18 years
Subject who has not objected to participation in the study.

Критерии исключения

For patients:

Patient with another co-existing malignant disease at the time of inclusion.
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.
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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет