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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 268
- 试验地点
- 17
- 主要终点
- Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Compare the proportion of patients for whom the supportive oncology care recommended in the personalized post-cancer plan has been implemented.
时间窗: 6 months after delivery of personalized post-cancer plan, i.e. about 8 months after inclusion
The primary criterion is the proportion of patients who have implemented at least one of the supportive oncology treatments recommended in the personalized post-cancer plan within 6 months of receiving the personalized post-cancer plan.
次要结局
- 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.(12 months after delivery of personalized post-cancer plan, i.e. about 14 months after inclusion)