Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)
NCT05818449 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 850
Last updated 2024-06-04
Summary
The aim of the DigiNet project is to improve the treatment of patients with advanced non-small cell lung cancer (NSCLC) in Germany. The project promotes the transfer of the latest scientific knowledge into standard care. The DigiNet project is based on the established precision medicine program, the National Network Genomic Medicine Lung Cancer (nNGM) in Germany, whereby every patient receives molecular diagnostics and personalized therapy information after the initial diagnosis. Within the framework of the DigiNet project, specialized academic centers will be digitally connected with practitioners via a shared project database. Furthermore, a committee of experts will monitor the course of treatment and will advise the practitioners in case of critical conditions. Additionally, patient-reported outcomes will be incorporated into the treatment.
Conditions
- Non-small Cell Lung Cancer Stage IV
Interventions
- OTHER
-
DigiNet intervention
Patients with initial diagnosis of NSCLC stage IV in the model region receiving the following interventions: * broad NGS-based molecular diagnostics and, based thereupon, personalized treatment information within the national Network Genomic Medicine (nNGM) lung cancer * regular clinical follow-up visits and data documentation in the shared central digital database by participating physicians * monthly assessment of patient-reported outcomes (PRO) on quality of life, anxiety, and depression * incorporation of PROs into treatment by physicians * treatment monitoring and counseling in the case of critical conditions by expert committee
Sponsors & Collaborators
-
Gemeinsamer Bundesausschuss (G-BA)
collaborator UNKNOWN -
AOK Rheinland/Hamburg
collaborator INDUSTRY -
AOK Nordwest
collaborator INDUSTRY -
BARMER
collaborator OTHER -
University Hospital, Essen
collaborator OTHER -
Charite University, Berlin, Germany
collaborator OTHER -
Berlin Institute of Health
collaborator OTHER -
Helios Klinikum Emil von Behring
collaborator UNKNOWN -
University Hospital Carl Gustav Carus
collaborator OTHER -
Deutsche Krebsgesellschaft e.V.
collaborator OTHER -
Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V.
collaborator UNKNOWN -
AOK Bundesverband
collaborator UNKNOWN -
FOM Hochschule für Oekonomie und Management
collaborator UNKNOWN -
University Medicine Greifswald
collaborator OTHER -
Technische Universität Dresden
collaborator OTHER -
University of Cologne
lead OTHER
Principal Investigators
-
Jürgen Wolf, Prof. Dr. · Uniklinik Köln
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-01
- Primary Completion
- 2025-03-31
- Completion
- 2025-03-31
Countries
- Germany
Study Locations
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