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

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: Active, not 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): 850
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Berlin, Germany, 12351
    • Vivantes Klinikum Neukölln
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin
  • Berlin, Germany, 14165
    • Helios Klinikum Emil Von Behring
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Berlin, Germany, 13359
    • DRK Kliniken Berlin Mitte
  • Berlin, Germany, 14195
    • Onkologischer Schwerpunkt am Oskar-Helene-Heim
  • Berlin, Germany, 14089
    • Gemeinschaftskrankenhaus Havelhöhe
  • Berlin, Germany, 10559
    • Onkologische Schwerpunktpraxis Tiergarten
  • Berlin, Germany, 10715
    • Praxis am Volkspark
  • Bayern
    • Würzburg, Bayern, Germany, 97080
      • Universitätsklinikum Würzburg
  • Brandenburg
    • Bad Liebenwerda, Brandenburg, Germany, 04924
      • Hämatologisch-Onkologische Schwerpunktpraxis
  • NRW
    • Aachen, NRW, Germany, 52074
      • Universitätsklinikum Aachen
    • Bonn, NRW, Germany, 53113
      • Johanniter-Krankenhaus Bonn
    • Bonn, NRW, Germany, 53123
      • Onkozentrum Bonn
    • Bonn, NRW, Germany, 53127
      • Universitätsklinikum Bonn (UKB)
    • Brühl, NRW, Germany, 50321
      • Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)
    • Dortmund, NRW, Germany, 44263
      • Gemeinschaftspraxis für Hämatologie & Onkologie
    • Essen, NRW, Germany, 45147
      • Universitätsklinikum Essen
    • Hamm, NRW, Germany, 59065
      • Praxis für Hämatologie und Internistische Onkologie
    • Köln, NRW, Germany, 50937
      • Universitätsklinikum Köln
    • Köln, NRW, Germany, 50677
      • MV-Zentrum für Hämatologie und Onkologie
    • Köln, NRW, Germany, 51103
      • MVZ West GmbH Standort Köln-Kalk
    • Köln, NRW, Germany
      • Praxis Internistischer Onkologie und Hämatologie (pioh)
    • Leverkusen, NRW, Germany, 51375
      • Klinikum Leverkusen
    • Mönchengladbach, NRW, Germany, 41063
      • Kliniken Maria Hilf GmbH
    • Mülheim an der Ruhr, NRW, Germany, 45468
      • MVZ für Hämatologie und Onkologie
    • Recklinghausen, NRW, Germany, 45659
      • Praxis und Tagesklinik für Internistische Onkologie und Hämatologie
    • Solingen, NRW, Germany, 42699
      • Krankenhaus Bethanien Solingen
    • Troisdorf/Bonn-Beuel/Bad Honnef, NRW, Germany, 53840
      • Onkologie Rheinsieg
    • Wesel, NRW, Germany, 46483
      • MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel
    • Wesel, NRW, Germany, 46485
      • Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH
  • Sachsen
    • Aue-Bad Schlema, Sachsen, Germany, 08301
      • Onkologie Erzgebirge
    • Bautzen, Sachsen, Germany, 02625
      • Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH
    • Coswig, Sachsen, Germany, 01640
      • Fachkrankenhaus Coswig
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus Dresden
    • Dresden, Sachsen, Germany, 01307
      • Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex
    • Dresden, Sachsen, Germany, 01307
      • Gemeinschaftspraxis Hämatologie - Onkologie
    • Dresden/Freiberg/Meißen, Sachsen, Germany
      • Onkozentrum Dresden/Freiberg/Meißen
    • Zittau, Sachsen, Germany, 02763
      • Ambulante Onkologie Ostsachsen
  • Thüringen
    • Erfurt, Thüringen, Germany, 99089
      • Helios Klinikum Erfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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)	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.	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

Collaborators and Investigators

• 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

Helpful Links

• Project Website

Study record dates

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 (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Carcinoma, Non-Small-Cell Lung; Precision Medicine; Patient Reported Outcome Measures; Pathology, Molecular; Carcinoma, Non-Small-Cell Lung* / diagnosis; Carcinoma, Non-Small-Cell Lung* / genetics; Database Management Systems
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 01NVF20021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No