NCT05354973招募中不适用
ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Response time
研究概览
简要总结
This study is designed as a feasibility study implementing electronic Patient Reported Outcomes (ePRO) in CAR T treatment for hematological malignancies, in order to describe AE reporting. ePRO assessments will be explored for their feasibility to engage in monitoring and management of CAR T-related toxicities as well as using these digital ePRO tools may improve both, its safety and accessibility.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients > 18 years
- •Patients receiving CAR T cell treatment
- •Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions.
排除标准
- •Patients, whose compliance to the studies' protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted.
- •Patients with insufficient knowledge about the use of a smartphone.
结局指标
主要结局
Response time
时间窗: 84 day +/- 6 days
Response time in seconds obtained during trail-making test (ePRO) according to daily administration via consilium careTM app, as a potential indicator for ICANS and other CAR T cell therapy-related adverse events.
次要结局
- Occurrence and type of therapy-associated unplanned consultations(84 day +/- 6 days)
- Well-being(84 day +/- 6 days)
- Occurrence of CRS-related adverse events (ePRO)(84 day +/- 6 days)
- Adherence(84 day +/- 6 days)
- Number and severity of adverse events (AE) according to the CTCAE(84 day +/- 6 days)
研究者
研究点 (1)
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