Cancer Patient Remote Monitoring for Timely Communication Study
- Conditions
- NSCLC Stage IV
- Registration Number
- NCT06623786
- Lead Sponsor
- Asklepios proresearch
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Previous systemic treatment for metastatic or locally advanced disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adherence to use the remote monitoring app 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
- Secondary Outcome Measures
Name Time Method