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

NCT ID: NCT05818449

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-03-31

Brief 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.

Detailed 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.

Conditions

Non-small Cell Lung Cancer Stage IV

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DigiNet group

The intervention group will receive the DigiNet intervention.

Group Type: EXPERIMENTAL

DigiNet intervention

Intervention Type: OTHER

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

Comparison group

The comparison group will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with advanced NSCLC, stage IV
• Age > 18 years
• Life expectancy at least 4 weeks (initial assessment at inclusion in nNGM and confirmation at baseline (implementation of treatment decision))

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 lung cancer

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemeinsamer Bundesausschuss (G-BA)

UNKNOWN

Sponsor Role: collaborator

AOK Rheinland/Hamburg

INDUSTRY

Sponsor Role: collaborator

AOK Nordwest

INDUSTRY

Sponsor Role: collaborator

BARMER

OTHER

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Berlin Institute of Health

OTHER

Sponsor Role: collaborator

Helios Klinikum Emil von Behring

UNKNOWN

Sponsor Role: collaborator

University Hospital Carl Gustav Carus

OTHER

Sponsor Role: collaborator

Deutsche Krebsgesellschaft e.V.

OTHER

Sponsor Role: collaborator

Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V.

UNKNOWN

Sponsor Role: collaborator

AOK Bundesverband

UNKNOWN

Sponsor Role: collaborator

FOM Hochschule für Oekonomie und Management

UNKNOWN

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Juergen Wolf

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jürgen Wolf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Uniklinik Köln

Locations

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Hämatologisch-Onkologische Schwerpunktpraxis

Bad Liebenwerda, Brandenburg, Germany

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Johanniter-Krankenhaus Bonn

Bonn, North Rhine-Westphalia, Germany

Onkozentrum Bonn

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum Bonn (UKB)

Bonn, North Rhine-Westphalia, Germany

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

Brühl, North Rhine-Westphalia, Germany

MV-Zentrum für Hämatologie und Onkologie

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

MVZ West GmbH Standort Köln-Kalk

Cologne, North Rhine-Westphalia, Germany

Praxis Internistischer Onkologie und Hämatologie (pioh)

Cologne, North Rhine-Westphalia, Germany

Gemeinschaftspraxis für Hämatologie & Onkologie

Dortmund, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Praxis für Hämatologie und Internistische Onkologie

Hamm, North Rhine-Westphalia, Germany

Klinikum Leverkusen

Leverkusen, North Rhine-Westphalia, Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, North Rhine-Westphalia, Germany

MVZ für Hämatologie und Onkologie

Mülheim, North Rhine-Westphalia, Germany

Praxis und Tagesklinik für Internistische Onkologie und Hämatologie

Recklinghausen, North Rhine-Westphalia, Germany

Krankenhaus Bethanien Solingen

Solingen, North Rhine-Westphalia, Germany

Onkologie Rheinsieg

Troisdorf/Bonn-Beuel/Bad Honnef, North Rhine-Westphalia, Germany

MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel

Wesel, North Rhine-Westphalia, Germany

Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH

Wesel, North Rhine-Westphalia, Germany

Onkologie Erzgebirge

Aue-Bad Schlema, Saxony, Germany

Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH

Bautzen, Saxony, Germany

Fachkrankenhaus Coswig

Coswig, Saxony, Germany

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

Dresden, Saxony, Germany

Gemeinschaftspraxis Hämatologie - Onkologie

Dresden, Saxony, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, Germany

Onkozentrum Dresden/Freiberg/Meißen

Dresden/Freiberg/Meißen, Saxony, Germany

Ambulante Onkologie Ostsachsen

Zittau, Saxony, Germany

Helios Klinikum Erfurt

Erfurt, Thuringia, Germany

Charité Universitätsmedizin Berlin

Berlin, , Germany

Onkologische Schwerpunktpraxis Tiergarten

Berlin, , Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, , Germany

Praxis am Volkspark

Berlin, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

Evangelische Lungenklinik Berlin

Berlin, , Germany

DRK Kliniken Berlin Mitte

Berlin, , Germany

Gemeinschaftskrankenhaus Havelhöhe

Berlin, , Germany

Helios Klinikum Emil von Behring

Berlin, , Germany

Onkologischer Schwerpunkt am Oskar-Helene-Heim

Berlin, , Germany

Countries

Germany

References

Kastner A, Kron A, Eilers L, Spier A, Mildenberger V, Simic D, Stock S, Kron F, Scheffler M, Schillinger G, van den Berg N, Wolf J, Hoffmann W. DigiNet: Optimizing personalized care for patients with stage IV non-small cell lung cancer (NSCLC) through a digitally connected provider network-analysis plan of a prospective multicenter cohort trial. J Cancer Res Clin Oncol. 2025 Sep 9;151(9):244. doi: 10.1007/s00432-025-06275-x.

Reference Type: DERIVED

PMID: 40924208 (View on PubMed)

Related Links

https://diginet.nngm.de/

Project Website

Other Identifiers

01NVF20021

Identifier Type: -

Identifier Source: org_study_id