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临床试验/NCT06623786
NCT06623786尚未招募不适用

Cancer Patient Remote Monitoring for Timely Communication Study

Asklepios proresearch0 个研究点目标入组 100 人开始时间: 2024年10月最近更新:
适应症

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

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

研究者

发起方
Asklepios proresearch
申办方类型
Industry
责任方
Sponsor

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