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JOURNAL ONKOLOGIE – STUDIE
DigiNet

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

Rekrutierend

NCT-Nummer:
NCT05818449

Studienbeginn:
Juni 2022

Letztes Update:
09.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Cologne

Collaborator:
Gemeinsamer Bundesausschuss (G-BA), AOK Rheinland/Hamburg, AOK Nordwest, BARMER, University Hospital, Essen, Charite University, Berlin, Germany, Berlin Institute of Health, Helios Klinikum Emil von Behring, University Hospital Carl Gustav Carus, Deutsche Krebsges

Studienleiter

Jürgen Wolf, Prof. Dr.
Principal Investigator
Uniklinik Köln

Kontakt

Studienlocations
(3 von 46)

Hämatologisch-Onkologische Schwerpunktpraxis
04924 Bad Liebenwerda
(Brandenburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:

Phone: +49 35341 475134
E-Mail: info@onkologie-badliebenwerda.de» Ansprechpartner anzeigen
Johanniter-Krankenhaus Bonn
53113 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yon-Dschun Ko, Prof. Dr.
Phone: +49 228 543-2201
E-Mail: Yon-Dschun.ko@johanniter-kliniken.de» Ansprechpartner anzeigen
Universitätsklinikum Bonn (UKB)
53127 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Franz G. Bauernfeind, Dr. med.
Phone: +49 228 287-17059
E-Mail: franz-georg.bauernfeind@ukbonn.de» Ansprechpartner anzeigen
Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)
50321 Brühl
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sebastian Stier, PD. Dr. med.
Phone: +49 2232 504010
E-Mail: sstier@zaho-rheinland.de» Ansprechpartner anzeigen
Klinikum Dortmund GmbH
44137 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Bernhard Schaaf, PD Dr. med.
Phone: +49 231 95318190
E-Mail: bernhard.schaaf@klinikumdo.de» Ansprechpartner anzeigen
Gemeinschaftspraxis für Hämatologie & Onkologie
44263 Dortmund
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Monika Ludwig, Dr.
Phone: +49 231 206 1692
E-Mail: monika.ludwig@gefos-dortmund.de» Ansprechpartner anzeigen
Universitätsklinikum Düsseldorf (UKD)
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Stephanie Keymel, Dr. med.
Phone: +49 211 8117897
E-Mail: Stefanie.Keymel@med.uni-duesseldorf.de» Ansprechpartner anzeigen
Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Martin Schuler, Prof. Dr.
Phone: +49 201 723 20 00
E-Mail: Martin.Schuler@uk-essen.de» Ansprechpartner anzeigen
Onkologische Gemeinschaftspraxis
33332 Gütersloh
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Philipp Schütt, PD Dr. med.
Phone: +49 5241 8328100
E-Mail: schuett@onkologie-guetersloh.de» Ansprechpartner anzeigen
Praxis für Hämatologie und Internistische Onkologie
59065 Hamm
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Oliver Christ, Dr. med.
Phone: +49 2381 94304-0
E-Mail: o.christ@onkologie-hamm.de» Ansprechpartner anzeigen
MV-Zentrum für Hämatologie und Onkologie
50677 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jan Weber, Dr. med.
Phone: +49 221 931822 0
E-Mail: Weber@oncokoeln.de» Ansprechpartner anzeigen
MVZ West GmbH Standort Köln-Kalk
51103 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Nathalie Bauer, Dr.
Phone: +4922198944717
E-Mail: bod.dr.nathalie.bauer@gmail.com» Ansprechpartner anzeigen
Praxis Internistischer Onkologie und Hämatologie (pioh)
Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Märkische Kliniken GmbH, Klinikum Lüdenscheid
58515 Lüdenscheid
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Karl-Josef Franke, PD Dr. med.
Phone: +49 2351 463360
E-Mail: karl.josef.franke@klinikum-luedenscheid.de» Ansprechpartner anzeigen
Darmzentrum der Kliniken Maria Hilf GmbH Mönchengladbach
Sandradstraße 43
41061 Mönchengladbach
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Ullrich Graeven, Prof. Dr.
Phone: +49 2161 8922201
E-Mail: ullrich.graeven@mariahilf.de» Ansprechpartner anzeigen
Praxis und Tagesklinik für Internistische Onkologie und Hämatologie
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Till-Oliver Emde
Phone: +49 2361 904270
E-Mail: emde@onkologie-re.de» Ansprechpartner anzeigen
Krankenhaus Bethanien Solingen
42699 Solingen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Britta Kaminsky, Dr. med.
Phone: +49 212 636730
E-Mail: britta.kaminsky@klinik-bethanien.de» Ansprechpartner anzeigen
Onkologie Rheinsieg
53840 Troisdorf/Bonn-Beuel/Bad Honnef
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ernst Rodermann, Dr. med.
Phone: +49 2241-39 75 66 0
E-Mail: rodermann@onkologie-rheinsieg.de» Ansprechpartner anzeigen
MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel
46483 Wesel
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:

Phone: +49 281 1041910
E-Mail: onkologie.mvz@prohomine.de» Ansprechpartner anzeigen
Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH
46485 Wesel
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Michael Trapp, Dr. med.
Phone: +49 (0) 2811 062344
E-Mail: michael.trapp@mvzevkwesel.de» Ansprechpartner anzeigen
Lungenkrebszentrum am Fachkrankenhaus Coswig
Neucoswiger Straße 21
1640 Coswig
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Dirk Koschel, Dr. med.
Phone: +49 3523 65202
E-Mail: koschel@fachkrankenhaus-coswig.de» Ansprechpartner anzeigen
Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:

Phone: +49 351 44 16018
E-Mail: info@onkopraxis-dresden.de» Ansprechpartner anzeigen
Universitätsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Martin Wermke, Dr. med.
Phone: +49 351-458 4695
E-Mail: martin.wermke@uniklinikum-dresden.de» Ansprechpartner anzeigen
Darmzentrum am Ev. Diakonissenkrankenhaus Leipzig
Georg-Schwarz-Straße 49
4177 Leipzig
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Sylvia Gütz, Dr. med.
Phone: +49 341 4445840
E-Mail: sylvia.guetz@ediacon.de» Ansprechpartner anzeigen
Ambulante Onkologie Ostsachsen
02763 Zittau
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Mathias Schulze, Dr. med.
Phone: +49 3583 696554
E-Mail: praxis-dr.mathias.schulze@online.de» Ansprechpartner anzeigen
Lungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Jens-Uwe Bauer, Dr. med.
Phone: +49 361 781-2581
E-Mail: jens-uwe.bauer@helios-gesundheit.de» Ansprechpartner anzeigen
Alexianer St. Hedwig Kliniken Berlin GmbH
10115 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Alexander Kühnemund, Dr. med.
Phone: +49 30 23112868
E-Mail: a.kuehnemund@alexianer.de» Ansprechpartner anzeigen
Charité Universitätsmedizin Berlin
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ulrich Keilholz, Prof. Dr.
Phone: +49 30 450 564 222
E-Mail: Ulrich.Keilholz@charite.de» Ansprechpartner anzeigen
Onkologische Schwerpunktpraxis Kurfürstendamm
10707 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ingo Schwaner, Dr. med.
Phone: +49 30 88 77 42 57 0
E-Mail: ingo.schwaner@onkologie-kurfuerstendamm.de» Ansprechpartner anzeigen
Onkologisches Zentrum Gemeinschaftskrankenhaus Havelhöhe
Kladower Damm 221
14089 Berlin
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Christian Grah, Dr. med.
Phone: +49 3650 17020
E-Mail: christian.grah@havelhoehe.de» Ansprechpartner anzeigen
Helios Klinikum Emil von Behring
14165 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Susann Stephan-Falkenau, Dr. med.
Phone: +49 30 8102 63580
E-Mail: susann.stephan-falkenau@helios-gesundheit.de» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - up to 34 months):
Overall Survival (OS) will be assessed in months.



Secondary outcome:

1. Progression-Free Survival (PFS) (Time Frame - up to 34 months):
Progression-Free Survival (PFS) will be assessed in months.

2. Time on First Treatment (ToT) (Time Frame - up to 34 months):
Duration under first-line therapy will be assessed in months.

3. Hospitalization rate (Time Frame - up to 34 months):
Frequency of hospital stays will be assessed using health insurance data.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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

10. 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 %.

11. 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

12. 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

13. 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]

14. 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 (€)

15. 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 (€)

16. Formative evaluation (Time Frame - up to 34 months):
Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews

Studien-Arme

  • Experimental: DigiNet group
    The intervention group will receive the DigiNet intervention.
  • No Intervention: Comparison group
    The comparison group will receive usual care.

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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