Cancer Patient Remote Monitoring for Timely Communication Study

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.

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Key information

Conditions

NSCLC Stage IV Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

adherence to use the remote monitoring app

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dagmar Pilz

CONTACT

[email protected]

+49 40 1818 853160

Nele Geßler

CONTACT

[email protected]

+49 40 1818853160

Sponsors and collaborators

Lead sponsor

Asklepios proresearch

Industry

Collaborators

Medical University of Vienna
Q1.6 B.V.

Registry information

Acronym: CONNECT

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Oct 2, 2024
Registry last updated: Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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