Cancer Patient Remote Monitoring for Timely Communication Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: NSCLC Stage IV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- adherence to use the remote monitoring app [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Previous systemic treatment for metastatic or locally advanced disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06623786 · The CONNECT Study