Trial Title:
Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)
NCT ID:
NCT05818449
Condition:
Non-small Cell Lung Cancer Stage IV
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Non-Small-Cell Lung* / diagnosis
Carcinoma, Non-Small-Cell Lung* / genetics
Precision Medicine
Pathology, Molecular
Patient Reported Outcome Measures
Database Management Systems
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
DigiNet intervention
Description:
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
Arm group label:
DigiNet group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinikum Würzburg
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Facility:
Name:
Hämatologisch-Onkologische Schwerpunktpraxis
Address:
City:
Bad Liebenwerda
Zip:
04924
Country:
Germany
Facility:
Name:
Universitätsklinikum Aachen
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Facility:
Name:
Johanniter-Krankenhaus Bonn
Address:
City:
Bonn
Zip:
53113
Country:
Germany
Facility:
Name:
Onkozentrum Bonn
Address:
City:
Bonn
Zip:
53123
Country:
Germany
Facility:
Name:
Universitätsklinikum Bonn (UKB)
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Facility:
Name:
Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)
Address:
City:
Brühl
Zip:
50321
Country:
Germany
Facility:
Name:
Gemeinschaftspraxis für Hämatologie & Onkologie
Address:
City:
Dortmund
Zip:
44263
Country:
Germany
Facility:
Name:
Universitätsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Facility:
Name:
Praxis für Hämatologie und Internistische Onkologie
Address:
City:
Hamm
Zip:
59065
Country:
Germany
Facility:
Name:
MV-Zentrum für Hämatologie und Onkologie
Address:
City:
Köln
Zip:
50677
Country:
Germany
Facility:
Name:
Universitätsklinikum Köln
Address:
City:
Köln
Zip:
50937
Country:
Germany
Facility:
Name:
MVZ West GmbH Standort Köln-Kalk
Address:
City:
Köln
Zip:
51103
Country:
Germany
Facility:
Name:
Praxis Internistischer Onkologie und Hämatologie (pioh)
Address:
City:
Köln
Country:
Germany
Facility:
Name:
Klinikum Leverkusen
Address:
City:
Leverkusen
Zip:
51375
Country:
Germany
Facility:
Name:
Kliniken Maria Hilf GmbH
Address:
City:
Mönchengladbach
Zip:
41063
Country:
Germany
Facility:
Name:
MVZ für Hämatologie und Onkologie
Address:
City:
Mülheim an der Ruhr
Zip:
45468
Country:
Germany
Facility:
Name:
Praxis und Tagesklinik für Internistische Onkologie und Hämatologie
Address:
City:
Recklinghausen
Zip:
45659
Country:
Germany
Facility:
Name:
Krankenhaus Bethanien Solingen
Address:
City:
Solingen
Zip:
42699
Country:
Germany
Facility:
Name:
Onkologie Rheinsieg
Address:
City:
Troisdorf/Bonn-Beuel/Bad Honnef
Zip:
53840
Country:
Germany
Facility:
Name:
MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel
Address:
City:
Wesel
Zip:
46483
Country:
Germany
Facility:
Name:
Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH
Address:
City:
Wesel
Zip:
46485
Country:
Germany
Facility:
Name:
Onkologie Erzgebirge
Address:
City:
Aue-Bad Schlema
Zip:
08301
Country:
Germany
Facility:
Name:
Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH
Address:
City:
Bautzen
Zip:
02625
Country:
Germany
Facility:
Name:
Fachkrankenhaus Coswig
Address:
City:
Coswig
Zip:
01640
Country:
Germany
Facility:
Name:
Onkozentrum Dresden/Freiberg/Meißen
Address:
City:
Dresden/Freiberg/Meißen
Country:
Germany
Facility:
Name:
Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Gemeinschaftspraxis Hämatologie - Onkologie
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Universitätsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Ambulante Onkologie Ostsachsen
Address:
City:
Zittau
Zip:
02763
Country:
Germany
Facility:
Name:
Helios Klinikum Erfurt
Address:
City:
Erfurt
Zip:
99089
Country:
Germany
Facility:
Name:
Charité Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Facility:
Name:
Onkologische Schwerpunktpraxis Tiergarten
Address:
City:
Berlin
Zip:
10559
Country:
Germany
Facility:
Name:
Onkologische Schwerpunktpraxis Kurfürstendamm
Address:
City:
Berlin
Zip:
10707
Country:
Germany
Facility:
Name:
Praxis am Volkspark
Address:
City:
Berlin
Zip:
10715
Country:
Germany
Facility:
Name:
Vivantes Klinikum Neukölln
Address:
City:
Berlin
Zip:
12351
Country:
Germany
Facility:
Name:
Evangelische Lungenklinik Berlin
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Facility:
Name:
DRK Kliniken Berlin Mitte
Address:
City:
Berlin
Zip:
13359
Country:
Germany
Facility:
Name:
Gemeinschaftskrankenhaus Havelhöhe
Address:
City:
Berlin
Zip:
14089
Country:
Germany
Facility:
Name:
Helios Klinikum Emil von Behring
Address:
City:
Berlin
Zip:
14165
Country:
Germany
Facility:
Name:
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Address:
City:
Berlin
Zip:
14195
Country:
Germany
Start date:
June 1, 2022
Completion date:
March 31, 2025
Lead sponsor:
Agency:
University of Cologne
Agency class:
Other
Collaborator:
Agency:
Gemeinsamer Bundesausschuss (G-BA)
Agency class:
Other
Collaborator:
Agency:
AOK Rheinland/Hamburg
Agency class:
Industry
Collaborator:
Agency:
AOK Nordwest
Agency class:
Industry
Collaborator:
Agency:
BARMER
Agency class:
Other
Collaborator:
Agency:
University Hospital, Essen
Agency class:
Other
Collaborator:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Collaborator:
Agency:
Berlin Institute of Health
Agency class:
Other
Collaborator:
Agency:
Helios Klinikum Emil von Behring
Agency class:
Other
Collaborator:
Agency:
University Hospital Carl Gustav Carus
Agency class:
Other
Collaborator:
Agency:
Deutsche Krebsgesellschaft e.V.
Agency class:
Other
Collaborator:
Agency:
Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V.
Agency class:
Other
Collaborator:
Agency:
AOK Bundesverband
Agency class:
Other
Collaborator:
Agency:
FOM Hochschule für Oekonomie und Management
Agency class:
Other
Collaborator:
Agency:
University Medicine Greifswald
Agency class:
Other
Collaborator:
Agency:
Technische Universität Dresden
Agency class:
Other
Source:
University of Cologne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05818449
https://diginet.nngm.de/
