Evaluation of an Organized Consultation "Return Home" of Patients With a Cancer (CREDO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 667
- 试验地点
- 5
- 主要终点
- Evaluation of an organized consultation "return home" of patients with a metastatic cancer
研究概览
简要总结
Prospective, open label, randomized and multicentric study evaluating the efficacy of an organized consultation "return home" compared to a current standard of care in patient hospitalized due to metastatic solid tumor cancer.
Subject will be randomized (1:1) as described below :
• Arm A (standard) : current standard of care ; connection documentation faxed to GP ( General practitioner) on the day of patient's discharge Arm B (experimental) : CREDO standard of care, organized consultation "return home" between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years old
- •Subject hospitalized in an oncology dedicated center for administration of the first chemotherapy cycle.
- •Subject with metastatic solid tumor whatever the organ
- •subject planned to be discharged home after chemotherapy administration
- •Affiliated to the French social security system.
- •Subjects must provide written informed consent prior to any study-specific procedure or assessment
排除标准
- •Subject included in another trial evaluating the pathways care
- •Pregnant or breastfeedings women
- •Subject law protected
研究组 & 干预措施
Arm B (experimental)
干预措施: CREDO standard of care (Other)
Arm A (standard)
干预措施: current standard of care (Other)
结局指标
主要结局
Evaluation of an organized consultation "return home" of patients with a metastatic cancer
时间窗: up to 12 months
Evaluation of number of non planned consultation and hospitalization compared to current standard of care
次要结局
- To assess the medical and economic consequences of the 2 standard of care (current and CREDO)(up to 12 months)
- Comparison of the 2 standard of care (current and CREDO) regarding subject' satisfaction(up to 12 months)
- Identification of the conformity of the standard of care regarding the place of care(up to 12 months)
- To quantify the caregiver burden in the 2 standard of care (current and CREDO)(up to 12 months)
- Comparison of the 2 standard of care (current and CREDO) regarding subject's quality of life(up to 12 months)