Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)

Last updated: June 3, 2024
Sponsor: University of Cologne
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

DigiNet intervention

Clinical Study ID

NCT05818449
01NVF20021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with advanced NSCLC, stage IV

  • Age > 18 years

  • Life expectancy at least 4 weeks (initial assessment at inclusion in nNGM andconfirmation at baseline (implementation of treatment decision))

Exclusion

Exclusion Criteria:

  • Missing informed consent

  • Illnesses and behaviors that impair compliance (e.g., dementia, addictive disorders)

  • Severely impaired general physical condition that no longer permits therapy for lungcancer

Study Design

Total Participants: 850
Treatment Group(s): 1
Primary Treatment: DigiNet intervention
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
March 31, 2025

Study Description

The aim of the DigiNet project is to prospectively evaluate a precision medicine program for lung cancer and to improve personalized care of patients with advanced non-small cell lung cancer (NSCLC) through a collaboration of specialized academic centers with routine care providers (hospitals, oncology practices). The use of targeted therapies will be regularly monitored and guided through a shared digital database. Patients with an initial diagnosis of stage IV NSCLC in the study regions (study region east: Berlin and Saxony; study region west: North Rhine-Westphalia) are included. DigiNet builds on the foundations and structures of the National Network Genomic Medicine Lung Cancer (nNGM) in Germany, which provides molecular diagnostics and treatment information to the participating physicians based on the latest evidence.

Within the framework of DigiNet, patients are regularly consulted by the study practitioners and the clinical data is documented in a structured manner in a central project database. Through the digital collaboration of the nNGM network centers via the shared project database with the practitioners in routine care, continuous monitoring of the course of treatment and, in the case of critical conditions, treatment guidance by an expert committee advising the practitioner is provided. In addition, the patients routinely assess the quality of life (EORTC QLQ-C30, EORTC QLQ-LC29, EQ-5D), as well as anxiety and depression (PHQ-4). The results of these patient-reported outcomes (PROs) are incorporated into the treatment by the practitioners (patient-centered treatment approach).

The evaluation of the project is structured into different core domains: An evaluation of clinical endpoints, process parameters (implementation of the intervention), and health economic evaluations will be conducted. The acceptance and potential for improvement of the project will be assessed through qualitative interviews with the stakeholders. Data from the state cancer registries of the study regions will be incorporated to generate a population-based comparative cohort for the evaluation of the main research questions of DigiNet, thereby representing patients receiving routine care in Germany.

Connect with a study center

  • Universitätsklinikum Würzburg

    Würzburg, Bayern 97080
    Germany

    Site Not Available

  • Hämatologisch-Onkologische Schwerpunktpraxis

    Bad Liebenwerda, Brandenburg 04924
    Germany

    Site Not Available

  • Universitätsklinikum Aachen

    Aachen, NRW 52074
    Germany

    Site Not Available

  • Johanniter-Krankenhaus Bonn

    Bonn, NRW 53113
    Germany

    Site Not Available

  • Onkozentrum Bonn

    Bonn, NRW 53123
    Germany

    Site Not Available

  • Universitätsklinikum Bonn (UKB)

    Bonn, NRW 53127
    Germany

    Site Not Available

  • Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)

    Brühl, NRW 50321
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Hämatologie & Onkologie

    Dortmund, NRW 44263
    Germany

    Site Not Available

  • Klinikum Dortmund GmbH

    Dortmund, NRW 44137
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf (UKD)

    Düsseldorf, NRW 40225
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, NRW 45147
    Germany

    Site Not Available

  • Onkologische Gemeinschaftspraxis

    Gütersloh, NRW 33332
    Germany

    Site Not Available

  • Praxis für Hämatologie und Internistische Onkologie

    Hamm, NRW 59065
    Germany

    Site Not Available

  • MV-Zentrum für Hämatologie und Onkologie

    Köln, NRW 50677
    Germany

    Site Not Available

  • MVZ West GmbH Standort Köln-Kalk

    Köln, NRW 51103
    Germany

    Site Not Available

  • Praxis Internistischer Onkologie und Hämatologie (pioh)

    Köln, NRW
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Köln, NRW 50937
    Germany

    Site Not Available

  • Klinikum Leverkusen

    Leverkusen, NRW 51375
    Germany

    Site Not Available

  • Märkische Kliniken GmbH, Klinikum Lüdenscheid

    Lüdenscheid, NRW 58515
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, NRW 41063
    Germany

    Site Not Available

  • MVZ für Hämatologie und Onkologie

    Mülheim an der Ruhr, NRW 45468
    Germany

    Site Not Available

  • Praxis und Tagesklinik für Internistische Onkologie und Hämatologie

    Recklinghausen, NRW 45659
    Germany

    Site Not Available

  • Krankenhaus Bethanien Solingen

    Solingen, NRW 42699
    Germany

    Site Not Available

  • Onkologie Rheinsieg

    Troisdorf/Bonn-Beuel/Bad Honnef, NRW 53840
    Germany

    Site Not Available

  • MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel

    Wesel, NRW 46483
    Germany

    Site Not Available

  • Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH

    Wesel, NRW 46485
    Germany

    Site Not Available

  • Onkologie Erzgebirge

    Aue-Bad Schlema, Sachsen 08301
    Germany

    Site Not Available

  • Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH

    Bautzen, Sachsen 02625
    Germany

    Site Not Available

  • Fachkrankenhaus Coswig

    Coswig, Sachsen 01640
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Gemeinschaftspraxis Hämatologie - Onkologie

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Onkozentrum Dresden/Freiberg/Meißen

    Dresden/Freiberg/Meißen, Sachsen
    Germany

    Site Not Available

  • Ev. Diakonissenkrankenhaus Leipzig

    Leipzig, Sachsen 04177
    Germany

    Site Not Available

  • Ambulante Onkologie Ostsachsen

    Zittau, Sachsen 02763
    Germany

    Site Not Available

  • Helios Klinikum Erfurt

    Erfurt, Thüringen 99089
    Germany

    Site Not Available

  • Alexianer St. Hedwig Kliniken Berlin GmbH

    Berlin, 10115
    Germany

    Active - Recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • DRK Kliniken Berlin Mitte

    Berlin, 13359
    Germany

    Site Not Available

  • Evangelische Lungenklinik Berlin

    Berlin, 13125
    Germany

    Site Not Available

  • Gemeinschaftskrankenhaus Havelhöhe

    Berlin, 14089
    Germany

    Site Not Available

  • Helios Klinikum Emil von Behring

    Berlin, 14165
    Germany

    Site Not Available

  • Lungenarztpraxis Tegel

    Berlin, 13507
    Germany

    Active - Recruiting

  • Onkologie Seestraße

    Berlin, 13347
    Germany

    Active - Recruiting

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707
    Germany

    Site Not Available

  • Onkologische Schwerpunktpraxis Tiergarten

    Berlin, 10559
    Germany

    Site Not Available

  • Onkologischer Schwerpunkt am Oskar-Helene-Heim

    Berlin, 14195
    Germany

    Site Not Available

  • Praxis am Volkspark

    Berlin, 10715
    Germany

    Site Not Available

  • Vivantes Klinikum Neukölln

    Berlin, 12351
    Germany

    Site Not Available

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