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Cancer Patient Remote Monitoring for Timely Communication Study

Sponsored by Asklepios proresearch

About this trial

Last updated 8 months ago

Study ID

The CONNECT Study

Status

Not yet recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 8 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

Exclusion Criteria

- Previous systemic treatment for metastatic or locally advanced disease