Impact of a Multidisciplinary Assessment in Day Hospitalization Versus Standard Care on the Deployment of Supportive Oncology Care Recommended by the Personalized Post-cancer Plan in Patients at the End of Initial Treatment for Gynecological Ovarian and Endometrial Cancer Endometrial 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: Multidisciplinary assessment, Standard assesment, Observational cohort.
- Кому может быть актуально
- Состояния в реестре: Gynecologic Cancer, Remission. Базовые параметры: от 18 лет · Женщины.
- 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
This project proposes a structuring of supportive oncology care for the recovery phase after gynecological cancer (ovarian/trope/peritoneum or endometrium). Patients will be divided into three groups based on the identification of oncological support care needs. Patients with supportive oncology care needs will be randomized into two groups: the experimental group, receiving a personalized post-cancer plan with a multidisciplinary assessment of supportive oncology care needs in a day hospital and coordinated follow-up by the referring study nurse, and the control group, receiving a personalized post-cancer plan without a day hospital. Randomization will be stratified according to tumor location (ovary vs. endometrium), use of supportive oncology care during treatment, and treatment center. Patients with no need for supportive oncology care will be followed in an observational cohort. The main objective is to identify and manage the supportive oncology care needs of patients in remission from endometrial or ovarian cancer to improve their quality of life and post-treatment follow-up. A medico-economic analysis will be performed.
Вмешательства
- Другое Multidisciplinary assessment
Delivery of a personalized post-cancer plan with multidisciplinary assessment of oncology support care needs in a day hospital - Другое Standard assesment
Delivery of a personalized post-cancer plan without a day hospital - Другое Observational cohort
Patients with no cancer sequelae, no adverse effects and no need for oncological support care will not be randomized, but will be followed as part of an observational cohort
Первичные конечные точки
- Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented. [Срок оценки: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion]
Вторичные конечные точки (1)
- Comparison, 12 months after delivery of the personalized post-cancer plan, of the impact of the intervention on the improvement of side effects and/or sequelae identified at the end of the initial treatments. [Срок оценки: 12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion]
Критерии участия
Критерии включения
- Patient > 18 years
- Patients in remission from first-line treatment of endometrial or ovarian/tumor/peritoneal cancer.
- Patient who has completed her initial treatment; patients on maintenance therapy are eligible.
- Fluency in French
- Patient with access to a telephone line
- Patient affiliated to a social security scheme
- Signature of informed consent prior to any specific study procedure
Критерии исключения
- Any associated medical or psychiatric condition that could compromise the patient's ability to participate in the study
- Patient with locoregional or metastatic recurrence
- Patient deprived of liberty, under guardianship or curatorship
- Simultaneous participation in a therapeutic clinical trial
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Франция · 13 центров
- CHU, Besançon — Besançon
- François Baclesse — Caen
- Centre Jean Perrin — Clermont-Ferrand
- Centre Léon Bérard — Lyon
- Hopital Diaconesses Croix Saint-Simon — Paris
- Hopital Europeen George Pompidou — Paris
- Hôpital COCHIN — Paris
- Institut Curie — Paris
- … и ещё 5 центров
Идентификаторы
NCT: NCT06553612 · 2023-A02554-41