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

August 8, 2023 updated by: Prof. Dr. Juergen Wolf, University of Cologne

Improvement of Personalized Cancer Care for Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Through Digital Connection of Specialized Cancer Centers, Community Hospitals, Private Practices and Patients (DigiNet)

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.

Study Overview

Status

Recruiting

Conditions

Non-small Cell Lung Cancer Stage IV

Intervention / Treatment

Other: DigiNet intervention

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.

Study Type

Interventional

Enrollment (Estimated)

2400

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Anna Kron, Dr.
Phone Number: +49 221 478-96775
Email: anna.kron@uk-koeln.de

Study Contact Backup

Name: Leonie Eilers, MSc
Phone Number: +49 22180147848
Email: leonie.eilers@bcw-gruppe.de

Study Locations

Germany
- - Berlin, Germany, 13125
    - Recruiting
    - Evangelische Lungenklinik Berlin
    - Contact:
      
      Christian Grohé, Prof. Dr.
      
      Phone Number: +49 30 948020
      
      Email: christian.grohe@elk-berlin.de
    - Principal Investigator:
      
      Christian Grohé, Prof. Dr.
  - Berlin, Germany, 14089
    - Recruiting
    - Gemeinschaftskrankenhaus Havelhöhe
    - Contact:
      
      Christian Grah, Dr. med.
      
      Phone Number: +49 3650 17020
      
      Email: christian.grah@havelhoehe.de
    - Principal Investigator:
      
      Christian Grah, Dr. med.
  - Berlin, Germany, 12351
    - Recruiting
    - Vivantes Klinikum Neukölln
    - Contact:
      
      Sven Gläser, Prof. Dr.
      
      Phone Number: +49 30 130 142030
      
      Email: Sven.Glaeser@vivantes.de
    - Principal Investigator:
      
      Sven Gläser, Prof. Dr.
  - Berlin, Germany, 10707
    - Recruiting
    - Onkologische Schwerpunktpraxis Kurfürstendamm
    - Contact:
      
      Ingo Schwaner, Dr. med.
      
      Phone Number: +49 30 88 77 42 57 0
      
      Email: ingo.schwaner@onkologie-kurfuerstendamm.de
    - Principal Investigator:
      
      Ingo Schwaner, Dr. med.
  - Berlin, Germany, 10117
    - Recruiting
    - Charite Universitatsmedizin Berlin
    - Contact:
      
      Ulrich Keilholz, Prof. Dr.
      
      Phone Number: +49 30 450 564 222
      
      Email: Ulrich.Keilholz@charite.de
    - Principal Investigator:
      
      Ulrich Keilholz, Prof. Dr.
  - Berlin, Germany, 14165
    - Recruiting
    - Helios Klinikum Emil von Behring
    - Contact:
      
      Susann Stephan-Falkenau, Dr. med.
      
      Phone Number: +49 30 8102 63580
      
      Email: susann.stephan-falkenau@helios-gesundheit.de
    - Principal Investigator:
      
      Susann Stephan-Falkenau, Dr. med.
  - Berlin, Germany, 10115
    - Recruiting
    - Alexianer St. Hedwig Kliniken Berlin GmbH
    - Contact:
      
      Alexander Kühnemund, Dr. med.
      
      Phone Number: +49 30 23112868
      
      Email: a.kuehnemund@alexianer.de
    - Principal Investigator:
      
      Alexander Kühnemund, Dr. med.
  - Berlin, Germany, 10559
    - Recruiting
    - Onkologische Schwerpunktpraxis Tiergarten
    - Contact:
      
      Phone Number: +49 30 394 20 03
      
      Email: anmeldung@onkologie-tiergarten.de
    - Principal Investigator:
      
      Dorothea Kingreen, Dr. med.
    - Principal Investigator:
      
      Antja Koschuth, Dr. med.
    - Principal Investigator:
      
      Jobst von Einem, Dr. med.
  - Berlin, Germany, 10715
    - Recruiting
    - Praxis am Volkspark
    - Contact:
      
      Phone Number: +49 30 84 72 35 35
      
      Email: info@praxis-am-volkspark-berlin.de
    - Principal Investigator:
      
      Oliver Schulz, Dr. med.
    - Principal Investigator:
      
      Meike Kollendt, Dr. med.
  - Berlin, Germany, 13347
    - Recruiting
    - Onkologie Seestraße
    - Contact:
      
      Phone Number: +49 30 76 90 90 90
      
      Email: praxis@onkologie-seestrasse.de
    - Principal Investigator:
      
      Jan Siehl, Dr. med.
    - Principal Investigator:
      
      Susanne Ganepola, Dr. med.
    - Principal Investigator:
      
      Ronny Schuster, Dr. med. Dr.
    - Principal Investigator:
      
      Alexander Schmittel, PD Dr. med.
  - Berlin, Germany, 13359
    - Recruiting
    - DRK Kliniken Berlin Mitte
    - Contact:
      
      Bernd Schmidt, Prof. Dr.
      
      Phone Number: +49 30 30356300
      
      Email: b.schmidt@drk-kliniken-berlin.de
    - Principal Investigator:
      
      Bernd Schmidt, Prof. Dr.
  - Berlin, Germany, 13507
    - Recruiting
    - Lungenarztpraxis Tegel
    - Contact:
      
      Phone Number: +49 30 4403070 20
      
      Email: mail@lungenarztpraxis-tegel.de
    - Principal Investigator:
      
      Vincent van Laak, Dr. med.
    - Principal Investigator:
      
      Daniel Binder, Dr. med.
  - Berlin, Germany, 14195
    - Recruiting
    - Onkologischer Schwerpunkt am Oskar-Helene-Heim
    - Contact:
      
      Phone Number: +49 30 644 99 5230
      
      Email: info@onkologie-ohh.de
    - Principal Investigator:
      
      Markus Schuler, PD Dr. med.
- Brandenburg
  - Bad Liebenwerda, Brandenburg, Germany, 04924
    - Recruiting
    - Hämatologisch-Onkologische Schwerpunktpraxis
    - Contact:
      
      Phone Number: +49 35341 475134
      
      Email: info@onkologie-badliebenwerda.de
    - Principal Investigator:
      
      Stephan Kreher, PD Dr. med.
- NRW
  - Bonn, NRW, Germany, 53113
    - Recruiting
    - Johanniter-Krankenhaus Bonn
    - Principal Investigator:
      
      Yon-Dschun Ko, Prof. Dr.
    - Contact:
      
      Yon-Dschun Ko, Prof. Dr.
      
      Phone Number: +49 228 543-2201
      
      Email: Yon-Dschun.ko@johanniter-kliniken.de
  - Bonn, NRW, Germany, 53127
    - Recruiting
    - Universitätsklinikum Bonn (UKB)
    - Contact:
      
      Franz G. Bauernfeind, Dr. med.
      
      Phone Number: +49 228 287-17059
      
      Email: franz-georg.bauernfeind@ukbonn.de
    - Principal Investigator:
      
      Franz G. Bauernfeind, Dr. med.
  - Brühl, NRW, Germany, 50321
    - Recruiting
    - Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)
    - Contact:
      
      Sebastian Stier, PD. Dr. med.
      
      Phone Number: +49 2232 504010
      
      Email: sstier@zaho-rheinland.de
    - Principal Investigator:
      
      Sebastian Stier, PD Dr. med.
  - Dortmund, NRW, Germany, 44137
    - Recruiting
    - Klinikum Dortmund GmbH
    - Contact:
      
      Bernhard Schaaf, PD Dr. med.
      
      Phone Number: +49 231 95318190
      
      Email: bernhard.schaaf@klinikumdo.de
    - Principal Investigator:
      
      Bernhard Schaaf, PD Dr. med.
  - Dortmund, NRW, Germany, 44263
    - Recruiting
    - Gemeinschaftspraxis für Hämatologie & Onkologie
    - Contact:
      
      Monika Ludwig, Dr.
      
      Phone Number: +49 231 206 1692
      
      Email: monika.ludwig@gefos-dortmund.de
    - Principal Investigator:
      
      Clemens Schulte, Dr. med. MBA
    - Principal Investigator:
      
      Sandra Ketzler-Henkel
  - Düsseldorf, NRW, Germany, 40225
    - Recruiting
    - Universitätsklinikum Düsseldorf (UKD)
    - Contact:
      
      Stephanie Keymel, Dr. med.
      
      Phone Number: +49 211 8117897
      
      Email: Stefanie.Keymel@med.uni-duesseldorf.de
    - Principal Investigator:
      
      Stephanie Keymel, Dr. med.
  - Essen, NRW, Germany, 45147
    - Recruiting
    - Universitatsklinikum Essen
    - Principal Investigator:
      
      Martin Schuler, Prof. Dr.
    - Contact:
      
      Martin Schuler, Prof. Dr.
      
      Phone Number: +49 201 723 20 00
      
      Email: Martin.Schuler@uk-essen.de
  - Gütersloh, NRW, Germany, 33332
    - Recruiting
    - Onkologische Gemeinschaftspraxis
    - Contact:
      
      Philipp Schütt, PD Dr. med.
      
      Phone Number: +49 5241 8328100
      
      Email: schuett@onkologie-guetersloh.de
    - Principal Investigator:
      
      Philipp Schütt, PD Dr. med.
  - Hamm, NRW, Germany, 59065
    - Recruiting
    - Praxis für Hämatologie und Internistische Onkologie
    - Contact:
      
      Oliver Christ, Dr. med.
      
      Phone Number: +49 2381 94304-0
      
      Email: o.christ@onkologie-hamm.de
    - Principal Investigator:
      
      Oliver Christ, Dr. med.
  - Köln, NRW, Germany, 50937
    - Recruiting
    - Universitätsklinikum Köln
    - Contact:
      
      Anna Kron, Dr.
      
      Phone Number: +49 221 478-96775
      
      Email: anna.kron@uk-koeln.de
    - Principal Investigator:
      
      Jürgen Wolf, Prof. Dr.
  - Köln, NRW, Germany, 50677
    - Recruiting
    - MV-Zentrum für Hämatologie und Onkologie
    - Contact:
      
      Jan Weber, Dr. med.
      
      Phone Number: +49 221 931822 0
      
      Email: Weber@oncokoeln.de
    - Principal Investigator:
      
      Kai Severin, Dr. med.
    - Principal Investigator:
      
      Stephan Schmitz, Prof. Dr.
    - Principal Investigator:
      
      Tilman Steinmetz, Dr. med.
    - Principal Investigator:
      
      Jan Weber, Dr. med.
  - Köln, NRW, Germany, 51103
    - Recruiting
    - MVZ West GmbH Standort Köln-Kalk
    - Contact:
      
      Nathalie Bauer, Dr.
      
      Phone Number: +4922198944717
      
      Email: bod.dr.nathalie.bauer@gmail.com
    - Principal Investigator:
      
      Achim Rothe, PD Dr. med.
  - Köln, NRW, Germany
    - Recruiting
    - Praxis Internistischer Onkologie und Hämatologie (pioh)
    - Principal Investigator:
      
      Matthias Hellmann, Dr. med.
    - Principal Investigator:
      
      Roland Schnell, PD Dr. med.
    - Principal Investigator:
      
      Holger Schulz, Dr. med.
    - Principal Investigator:
      
      Julia Lukanowski, Dr. med.
    - Principal Investigator:
      
      Marcel Reiser, PD Dr. med.
    - Principal Investigator:
      
      Andreas Draube, PD Dr. med.
  - Leverkusen, NRW, Germany, 51375
    - Recruiting
    - Klinikum Leverkusen
    - Contact:
      
      Utz Krug, PD Dr. med.
      
      Phone Number: +49 214 132671
      
      Email: utz.krug@klinikum-lev.de
    - Principal Investigator:
      
      Utz Krug, PD Dr. med.
  - Lüdenscheid, NRW, Germany, 58515
    - Recruiting
    - Märkische Kliniken GmbH, Klinikum Lüdenscheid
    - Contact:
      
      Karl-Josef Franke, PD Dr. med.
      
      Phone Number: +49 2351 463360
      
      Email: karl.josef.franke@klinikum-luedenscheid.de
    - Principal Investigator:
      
      Karl-Josef Franke, PD Dr. med.
  - Mönchengladbach, NRW, Germany, 41063
    - Recruiting
    - Kliniken Maria Hilf GmbH
    - Contact:
      
      Ullrich Graeven, Prof. Dr.
      
      Phone Number: +49 2161 8922201
      
      Email: ullrich.graeven@mariahilf.de
    - Principal Investigator:
      
      Ullrich Graeven, Prof. Dr.
  - Mülheim an der Ruhr, NRW, Germany, 45468
    - Recruiting
    - MVZ für Hämatologie und Onkologie
    - Contact:
      
      Phone Number: +49 208 76981
      
      Email: praxis@onkologie-mh.de
    - Principal Investigator:
      
      Jan Schröder, PD Dr. med.
  - Recklinghausen, NRW, Germany, 45659
    - Recruiting
    - Praxis und Tagesklinik für Internistische Onkologie und Hämatologie
    - Principal Investigator:
      
      Till-Oliver Emde
    - Contact:
      
      Till-Oliver Emde
      
      Phone Number: +49 2361 904270
      
      Email: emde@onkologie-re.de
  - Solingen, NRW, Germany, 42699
    - Recruiting
    - Krankenhaus Bethanien Solingen
    - Contact:
      
      Britta Kaminsky, Dr. med.
      
      Phone Number: +49 212 636730
      
      Email: britta.kaminsky@klinik-bethanien.de
    - Principal Investigator:
      
      Britta Kaminsky, Dr. med.
  - Troisdorf/Bonn-Beuel/Bad Honnef, NRW, Germany, 53840
    - Recruiting
    - Onkologie Rheinsieg
    - Contact:
      
      Ernst Rodermann, Dr. med.
      
      Phone Number: +49 2241-39 75 66 0
      
      Email: rodermann@onkologie-rheinsieg.de
    - Principal Investigator:
      
      Helmut Forstbauer, Dr. med.
    - Principal Investigator:
      
      Ruth Reihs, Dr. med.
    - Principal Investigator:
      
      Ernst Rodermann, Dr. med.
    - Principal Investigator:
      
      Andreas Diehl
    - Principal Investigator:
      
      Anke Herfort, Dr. med.
  - Wesel, NRW, Germany, 46483
    - Recruiting
    - MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel
    - Contact:
      
      Phone Number: +49 281 1041910
      
      Email: onkologie.mvz@prohomine.de
    - Principal Investigator:
      
      Mathias Hoiczyk, Dr. med.
  - Wesel, NRW, Germany, 46485
    - Recruiting
    - Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH
    - Contact:
      
      Michael Trapp, Dr. med.
      
      Phone Number: +49 (0) 2811 062344
      
      Email: michael.trapp@mvzevkwesel.de
    - Principal Investigator:
      
      Michael Trapp, Dr. med.
- Sachsen
  - Aue-Bad Schlema, Sachsen, Germany, 08301
    - Recruiting
    - Onkologie Erzgebirge
    - Contact:
      
      Marcus Rönitz, Dr. med.
      
      Phone Number: +49 3772 381933
      
      Email: roenitz@onkologie-erzgebirge.de
    - Principal Investigator:
      
      Andreas Thiel, Dr. med.
  - Bautzen, Sachsen, Germany, 02625
    - Recruiting
    - Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH
    - Contact:
      
      Phone Number: +49 35 91 404 24
      
      Email: praxis@oncos.de
    - Principal Investigator:
      
      Conrad Heuchel, Dr. med.
  - Coswig, Sachsen, Germany, 01640
    - Recruiting
    - Fachkrankenhaus Coswig
    - Contact:
      
      Dirk Koschel, Dr. med.
      
      Phone Number: +49 3523 65202
      
      Email: koschel@fachkrankenhaus-coswig.de
    - Principal Investigator:
      
      Dirk Koschel, Dr. med.
  - Dresden, Sachsen, Germany, 01307
    - Recruiting
    - Universitätsklinikum Carl Gustav Carus Dresden
    - Contact:
      
      Martin Wermke, Dr. med.
      
      Phone Number: +49 351-458 4695
      
      Email: martin.wermke@uniklinikum-dresden.de
    - Principal Investigator:
      
      Martin Wermke, Dr. med.
  - Dresden, Sachsen, Germany, 01307
    - Recruiting
    - Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex
    - Contact:
      
      Phone Number: +49 351 44 16018
      
      Email: info@onkopraxis-dresden.de
    - Principal Investigator:
      
      Johannes Mohm, Dr. med.
  - Dresden, Sachsen, Germany, 01307
    - Recruiting
    - Gemeinschaftspraxis Hämatologie - Onkologie
    - Contact:
      
      Phone Number: +49 351-447 23 4 0
    - Principal Investigator:
      
      Jens Freiberg-Richter, Dr. med.
    - Principal Investigator:
      
      Thomas Illmer, PD Dr. med.
  - Dresden/Freiberg/Meißen, Sachsen, Germany
    - Recruiting
    - Onkozentrum Dresden/Freiberg/Meißen
    - Principal Investigator:
      
      Thomas Göhler, Dr. med.
    - Contact:
      
      Phone Number: +49 351 795 255-0
      
      Email: goehler@onkozentrum.de
    - Principal Investigator:
      
      Thomas Boldt
    - Principal Investigator:
      
      Steffen Dörfel, Dipl.-Med.
    - Principal Investigator:
      
      Sebastian Thiele, Dr. med.
    - Principal Investigator:
      
      Michael Hering
  - Leipzig, Sachsen, Germany, 04177
    - Recruiting
    - Ev. Diakonissenkrankenhaus Leipzig
    - Contact:
      
      Sylvia Gütz, Dr. med.
      
      Phone Number: +49 341 4445840
      
      Email: sylvia.guetz@ediacon.de
    - Principal Investigator:
      
      Sylvia Gütz, Dr. med.
  - Zittau, Sachsen, Germany, 02763
    - Recruiting
    - Ambulante Onkologie Ostsachsen
    - Contact:
      
      Mathias Schulze, Dr. med.
      
      Phone Number: +49 3583 696554
      
      Email: praxis-dr.mathias.schulze@online.de
    - Principal Investigator:
      
      Mathias Schulze, Dr. med.
    - Principal Investigator:
      
      Ute Funke, Dr. med.
- Thüringen
  - Erfurt, Thüringen, Germany, 99089
    - Recruiting
    - Helios Klinikum Erfurt
    - Contact:
      
      Jens-Uwe Bauer, Dr. med.
      
      Phone Number: +49 361 781-2581
      
      Email: jens-uwe.bauer@helios-gesundheit.de
    - Principal Investigator:
      
      Jens-Uwe Bauer, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DigiNet group The intervention group will receive the DigiNet intervention.	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
No Intervention: Comparison group The comparison group will receive usual care.

Participant Group / Arm

Intervention / Treatment

Experimental: DigiNet group

The intervention group will receive the DigiNet intervention.

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

No Intervention: Comparison group

The comparison group will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: up to 34 months	Overall Survival (OS) will be assessed in months.	up to 34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Time Frame: up to 34 months	Progression-Free Survival (PFS) will be assessed in months.	up to 34 months
Time on First Treatment (ToT) Time Frame: up to 34 months	Duration under first-line therapy will be assessed in months.	up to 34 months
Hospitalization rate Time Frame: up to 34 months	Frequency of hospital stays will be assessed using health insurance data.	up to 34 months
Quality of Life (EORTC QLQ-C30) Time Frame: up to 34 months	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) Time Frame: up to 34 months	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) Time Frame: up to 34 months	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) Time Frame: up to 34 months	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 Time Frame: up to 34 months	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 Time Frame: up to 34 months	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 Time Frame: up to 34 months	Assessing the completeness of the documentation of the treatment course (DigiNet study visits) in %.	up to 34 months
Frequency of patients' completing the PROs Time Frame: up to 34 months	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 Time Frame: up to 34 months	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] Time Frame: up to 34 months	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) Time Frame: up to 34 months	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) Time Frame: up to 34 months	Assessing the process costs related to DigiNet from the service provider perspective (hospital, practices) in Euro (€)	up to 34 months
Formative evaluation Time Frame: up to 34 months	Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews	up to 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Collaborators

Charite University, Berlin, Germany

University Hospital, Essen

University Medicine Greifswald

Technische Universität Dresden

BARMER

University Hospital Carl Gustav Carus

Deutsche Krebsgesellschaft e.V.

AOK Rheinland/Hamburg

Berlin Institute of Health

Gemeinsamer Bundesausschuss (G-BA)

AOK Nordwest

Helios Klinikum Emil von Behring

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

AOK Bundesverband

FOM Hochschule für Oekonomie und Management

Investigators

Principal Investigator: Jürgen Wolf, Prof. Dr., Uniklinik Köln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Project Website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

01NVF20021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Non-small Cell Lung Cancer Stage IV

Clinical Trials on DigiNet intervention

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