Clinical trial NCT05818449: Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer Stage IV
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
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Gemeinsamer Bundesausschuss (G-BA)
name: AOK Rheinland/Hamburg
name: AOK Nordwest
name: BARMER
name: University Hospital, Essen
name: Charite University, Berlin, Germany
name: Berlin Institute of Health
name: Helios Klinikum Emil von Behring
name: University Hospital Carl Gustav Carus
name: Deutsche Krebsgesellschaft e.V.
name: Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V.
name: AOK Bundesverband
name: FOM Hochschule für Oekonomie und Management
name: University Medicine Greifswald
name: Technische Universität Dresden
First posted: 2023-04-18
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 34 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: up to 34 months
measure: Time on First Treatment (ToT)
timeFrame: up to 34 months
measure: Hospitalization rate
timeFrame: up to 34 months
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: up to 34 months
measure: Quality of Life (EORTC QLQ-LC29)
timeFrame: up to 34 months
measure: Symptoms of anxiety (GAD-2)
timeFrame: up to 34 months
measure: Symptoms of depression (PHQ-2)
timeFrame: up to 34 months
measure: Frequency of applied targeted molecular therapies based on clinical therapy information from the MURIEL database
timeFrame: up to 34 months
measure: Frequency of active contact of the expert advisory board with physicians during the course of treatment
timeFrame: up to 34 months
measure: Completeness of the documentation of the treatment course
timeFrame: up to 34 months
measure: Frequency of patients' completing the PROs
timeFrame: up to 34 months
measure: Cost-effectiveness of DigiNet compared to standard care in terms of incremental costs per life years gained
timeFrame: up to 34 months
measure: Cost-effectiveness of DigiNet compared to standard care in terms of costs per quality-adjusted life year [QALY]
timeFrame: up to 34 months
measure: Cost of implementation related to DigiNet from the service provider perspective (hospital, practices)
timeFrame: up to 34 months
measure: Process costs related to DigiNet from the service provider perspective (hospital, practices)
timeFrame: up to 34 months
measure: Formative evaluation
timeFrame: up to 34 months
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Bad Liebenwerda
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis
state: Brandenburg
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
state: NRW
city: Bonn
country: Germany
facility: Johanniter-Krankenhaus Bonn
state: NRW
city: Bonn
country: Germany
facility: Onkozentrum Bonn
state: NRW
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn (UKB)
state: NRW
city: Brühl
country: Germany
facility: Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)
state: NRW
city: Dortmund
country: Germany
facility: Gemeinschaftspraxis für Hämatologie & Onkologie
state: NRW
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: NRW
city: Hamm
country: Germany
facility: Praxis für Hämatologie und Internistische Onkologie
state: NRW
city: Köln
country: Germany
facility: MV-Zentrum für Hämatologie und Onkologie
state: NRW
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: NRW
city: Köln
country: Germany
facility: MVZ West GmbH Standort Köln-Kalk
state: NRW
city: Köln
country: Germany
facility: Praxis Internistischer Onkologie und Hämatologie (pioh)
state: NRW
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
state: NRW
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
state: NRW
city: Mülheim an der Ruhr
country: Germany
facility: MVZ für Hämatologie und Onkologie
state: NRW
city: Recklinghausen
country: Germany
facility: Praxis und Tagesklinik für Internistische Onkologie und Hämatologie
state: NRW
city: Solingen
country: Germany
facility: Krankenhaus Bethanien Solingen
state: NRW
city: Troisdorf/Bonn-Beuel/Bad Honnef
country: Germany
facility: Onkologie Rheinsieg
state: NRW
city: Wesel
country: Germany
facility: MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel
state: NRW
city: Wesel
country: Germany
facility: Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH
state: NRW
city: Aue-Bad Schlema
country: Germany
facility: Onkologie Erzgebirge
state: Sachsen
city: Bautzen
country: Germany
facility: Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH
state: Sachsen
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig
state: Sachsen
city: Dresden/Freiberg/Meißen
country: Germany
facility: Onkozentrum Dresden/Freiberg/Meißen
state: Sachsen
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex
state: Sachsen
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Hämatologie - Onkologie
state: Sachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Zittau
country: Germany
facility: Ambulante Onkologie Ostsachsen
state: Sachsen
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
state: Thüringen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Tiergarten
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Berlin
country: Germany
facility: Praxis am Volkspark
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Mitte
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring
city: Berlin
country: Germany
facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim
Study officials:
affiliation: Uniklinik Köln
name: Jürgen Wolf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: