NEMO - an App for Side Effect Management in Oncology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Phase I: Patient acceptance of a new medium of communication
研究概览
简要总结
This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.
详细描述
This research study is structured as a Phase I and II clinical trial. In phase I, the feasibility of using a smartphone application to document adverse events that have occurred during oncological therapies by the patient will be investigated. In phase II we will investigate whether the use of the smartphone app allows an improvement of patient care by reducing occurred adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •infusional combination therapy with at least two chemotherapy substances with or without further targeted therapies
- •combination of at least two immune-checkpoint inhibitors
- •able to read and understand German
排除标准
- •Participants who meet any of the following criteria will be excluded:
- •severe neurological disorders
- •severe psychiatric disorders
结局指标
主要结局
Phase I: Patient acceptance of a new medium of communication
时间窗: 6 months
Acceptance of documentation of occurring side effects of oncological therapies with new communication media
Phase II: Change of occurred adverse events
时间窗: 6 months
Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start
次要结局
- Phase II: Doses of chemotherapy(6 months)
- Phase II: Incidence of adverse events(6 months)
研究者
Thomas Seufferlein
Professor, Head of Department
University of Ulm