Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Sensitivity of the digital application
研究概览
简要总结
The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.
After cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <80 (if age>70 years, a G8 score>14 is required)
- •Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)
- •Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15
- •Familiar with digital tools
排除标准
- •Emergency
- •patient feeling unease with the use of a smartphone
研究组 & 干预措施
nurse then patient digital prevalidation of chemotherapy
Outpatient Chemotherapy prevalidation will done
- with the help of a nurse, using the digital application, for cycle 2 and 3.
- by the patient alone, using the digital application, for cycle 4 and 5.
干预措施: Chemotherapy prevalidation (Procedure)
结局指标
主要结局
Sensitivity of the digital application
时间窗: 6 weeks
Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician
次要结局
未报告次要终点