Cancer Patient Remote Monitoring for Timely Communication Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- adherence to use the remote monitoring app
研究概览
简要总结
The study is designed as a prospective, single-arm observational, mixed-method study. Patients with stage IV NSCLC or inoperable mesothelioma will be included and will be treated with immunotherapy according to current guidelines and standard of care. Patients may receive either a PD1/L1 inhibitor monotherapy or, if indicated, together with a CTLA4 inhibitor. Immunotherapy may be administered alone or together with chemotherapy as per site standard/physician's choice. Patients will be given access to a mobile app. Patients will receive daily questions via the app to assess immune-related adverse events between clinic visits and their well-being.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Signed Informed Consent Form
- •Age > 18 years at the time of study entry
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Life expectancy > 6 months
- •Patient is able and willing to use smart phone and a wearable device/technology/sensor
排除标准
- •Previous systemic treatment for metastatic or locally advanced disease
结局指标
主要结局
adherence to use the remote monitoring app
时间窗: 6 months
To measure the adherence to use the remote monitoring app, assessed as percentage of answered questions related to the total number of questions sent to the patients via Q1.6 app
次要结局
未报告次要终点
