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| Name | Class |
|---|---|
| Gemeinsamer Bundesaussschuss | OTHER |
| AOK Rheinland/Hamburg | INDUSTRY |
| AOK Nordwest | INDUSTRY |
| BARMER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DigiNet group | Experimental | The intervention group will receive the DigiNet intervention. |
|
| Comparison group | No Intervention | The comparison group will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DigiNet intervention | Other | Patients with initial diagnosis of NSCLC stage IV in the model region receiving the following interventions:
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) will be assessed in months. | up to 34 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) will be assessed in months. | up to 34 months |
| Time on First Treatment (ToT) | Duration under first-line therapy will be assessed in months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jürgen Wolf, Prof. Dr. | Uniklinik Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Würzburg | Würzburg | Bavaria | 97080 | Germany | ||
| Hämatologisch-Onkologische Schwerpunktpraxis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40924208 | Derived | 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. |
| Label | URL |
|---|---|
| Project Website | View source |
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| OTHER |
| University Hospital, Essen | OTHER |
| Charite University, Berlin, Germany | OTHER |
| Berlin Institute of Health | OTHER |
| Helios Klinikum Emil von Behring | UNKNOWN |
| University Hospital Carl Gustav Carus | OTHER |
| Deutsche Krebsgesellschaft e.V. | OTHER |
| Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V. | UNKNOWN |
| AOK Bundesverband | UNKNOWN |
| FOM Hochschule für Oekonomie und Management | UNKNOWN |
| University Medicine Greifswald | OTHER |
| Technische Universität Dresden | OTHER |
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|
| up to 34 months |
| Hospitalization rate | Frequency of hospital stays will be assessed using health insurance data. | up to 34 months |
| Quality of Life (EORTC QLQ-C30) | Quality of Life (European Organisation for Research and Treatment of Cancer, Quality of Life Core Questionnaire, EORTC QLQ-C30) will be assessed in absolute values and change over time. Each item is rated on a response scale 1 = "not at all" to 4 = "very much" with exception of the last two items, which assess overall health and quality of life on a scale from 1 = "very poor" to 7 = "excellent". All EORTC QLQ-C30 scale scores range from 0 to 100, whereby higher scores on a functional scale indicate a high level of functioning, whereas higher scores on a symptom scale/symptom item indicate greater symptom burden. | up to 34 months |
| Quality of Life (EORTC QLQ-LC29) | Quality of Life (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer, EORTC QLQ-LC29) will be assessed in absolute values and change over time. Each item is rated on a response scale 1 = "not at all" to 4 = "very much" and refer to the time frame "during the past week". All EORTC QLQ-LC29 scale scores range from 0 to 100, whereby higher scores for a symptom scale/symptom item indicate greater symptom burden. | up to 34 months |
| Symptoms of anxiety (GAD-2) | Symptoms of anxiety (Generalized Anxiety Disorder Scale-2, GAD-2) will be assessed in absolute values and change over time. Each item is rated on a response scale 0 = "not at all" to 3 = "nearly every day" and refer to the time frame "during the past two weeks". Higher scores indicate greater symptom burden. | up to 34 months |
| Symptoms of depression (PHQ-2) | Symptoms of depression (Patient-Health-Questionnaire-2, PHQ-2) will be assessed in absolute values and change over time. Each item is rated on a response scale 0 = "not at all" to 3 = "nearly every day" and refer to the time frame "during the past two weeks". Higher scores indicate greater symptom burden. | up to 34 months |
| Frequency of applied targeted molecular therapies based on clinical therapy information from the MURIEL database | The frequency of applied targeted molecular therapies is based on clinical therapy information from the MURIEL database. | up to 34 months |
| Frequency of active contact of the expert advisory board with physicians during the course of treatment | Assessing the frequency of the expert advisory board actively contacting physicians during the course of treatment | up to 34 months |
| Completeness of the documentation of the treatment course | Assessing the completeness of the documentation of the treatment course (DigiNet study visits) in %. | up to 34 months |
| Frequency of patients' completing the PROs | Assessing the frequency of patients' completing the patient-reported outcomes (PRO) via the internet portal | up to 34 months |
| Cost-effectiveness of DigiNet compared to standard care in terms of incremental costs per life years gained | Assessing the cost-effectiveness of DigiNet compared to standard care in terms of incremental costs per life years gained | up to 34 months |
| Cost-effectiveness of DigiNet compared to standard care in terms of costs per quality-adjusted life year [QALY] | Assessing the cost-effectiveness of DigiNet compared to standard care in terms of costs per quality-adjusted life year [QALY] | up to 34 months |
| Cost of implementation related to DigiNet from the service provider perspective (hospital, practices) | Assessing the cost of implementation related to DigiNet from the service provider perspective (hospital, practices) in Euro (€) | up to 34 months |
| Process costs related to DigiNet from the service provider perspective (hospital, practices) | Assessing the process costs related to DigiNet from the service provider perspective (hospital, practices) in Euro (€) | up to 34 months |
| Formative evaluation | Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews | up to 34 months |
| Bad Liebenwerda |
| Brandenburg |
| 04924 |
| Germany |
| Universitätsklinikum Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Johanniter-Krankenhaus Bonn | Bonn | North Rhine-Westphalia | 53113 | Germany |
| Onkozentrum Bonn | Bonn | North Rhine-Westphalia | 53123 | Germany |
| Universitätsklinikum Bonn (UKB) | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO) | Brühl | North Rhine-Westphalia | 50321 | Germany |
| MV-Zentrum für Hämatologie und Onkologie | Cologne | North Rhine-Westphalia | 50677 | Germany |
| Universitätsklinikum Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| MVZ West GmbH Standort Köln-Kalk | Cologne | North Rhine-Westphalia | 51103 | Germany |
| Praxis Internistischer Onkologie und Hämatologie (pioh) | Cologne | North Rhine-Westphalia | Germany |
| Gemeinschaftspraxis für Hämatologie & Onkologie | Dortmund | North Rhine-Westphalia | 44263 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| Praxis für Hämatologie und Internistische Onkologie | Hamm | North Rhine-Westphalia | 59065 | Germany |
| Klinikum Leverkusen | Leverkusen | North Rhine-Westphalia | 51375 | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | North Rhine-Westphalia | 41063 | Germany |
| MVZ für Hämatologie und Onkologie | Mülheim | North Rhine-Westphalia | 45468 | Germany |
| Praxis und Tagesklinik für Internistische Onkologie und Hämatologie | Recklinghausen | North Rhine-Westphalia | 45659 | Germany |
| Krankenhaus Bethanien Solingen | Solingen | North Rhine-Westphalia | 42699 | Germany |
| Onkologie Rheinsieg | Troisdorf/Bonn-Beuel/Bad Honnef | North Rhine-Westphalia | 53840 | Germany |
| MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel | Wesel | North Rhine-Westphalia | 46483 | Germany |
| Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH | Wesel | North Rhine-Westphalia | 46485 | Germany |
| Onkologie Erzgebirge | Aue-Bad Schlema | Saxony | 08301 | Germany |
| Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH | Bautzen | Saxony | 02625 | Germany |
| Fachkrankenhaus Coswig | Coswig | Saxony | 01640 | Germany |
| Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex | Dresden | Saxony | 01307 | Germany |
| Gemeinschaftspraxis Hämatologie - Onkologie | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | Saxony | 01307 | Germany |
| Onkozentrum Dresden/Freiberg/Meißen | Dresden/Freiberg/Meißen | Saxony | Germany |
| Ambulante Onkologie Ostsachsen | Zittau | Saxony | 02763 | Germany |
| Helios Klinikum Erfurt | Erfurt | Thuringia | 99089 | Germany |
| Charité Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Onkologische Schwerpunktpraxis Tiergarten | Berlin | 10559 | Germany |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| Praxis am Volkspark | Berlin | 10715 | Germany |
| Vivantes Klinikum Neukölln | Berlin | 12351 | Germany |
| Evangelische Lungenklinik Berlin | Berlin | 13125 | Germany |
| DRK Kliniken Berlin Mitte | Berlin | 13359 | Germany |
| Gemeinschaftskrankenhaus Havelhöhe | Berlin | 14089 | Germany |
| Helios Klinikum Emil von Behring | Berlin | 14165 | Germany |
| Onkologischer Schwerpunkt am Oskar-Helene-Heim | Berlin | 14195 | Germany |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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