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

Non-small Cell Lung Cancer Stage IV Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818449
• Other study ID #: 01NVF20021
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: University of Cologne
• Contact: Anna Kron, Dr.
• Phone: +49 221 478-96775
• Email: anna.kron[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage IV

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

Locations

Country	Name	City	State
Germany	Onkologie Erzgebirge	Aue-Bad Schlema	Sachsen
Germany	Hämatologisch-Onkologische Schwerpunktpraxis	Bad Liebenwerda	Brandenburg
Germany	Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH	Bautzen	Sachsen
Germany	Alexianer St. Hedwig Kliniken Berlin GmbH	Berlin
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	DRK Kliniken Berlin Mitte	Berlin
Germany	Evangelische Lungenklinik Berlin	Berlin
Germany	Gemeinschaftskrankenhaus Havelhöhe	Berlin
Germany	Helios Klinikum Emil von Behring	Berlin
Germany	Lungenarztpraxis Tegel	Berlin
Germany	Onkologie Seestraße	Berlin
Germany	Onkologische Schwerpunktpraxis Kurfürstendamm	Berlin
Germany	Onkologische Schwerpunktpraxis Tiergarten	Berlin
Germany	Onkologischer Schwerpunkt am Oskar-Helene-Heim	Berlin
Germany	Praxis am Volkspark	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Johanniter-Krankenhaus Bonn	Bonn	NRW
Germany	Universitätsklinikum Bonn (UKB)	Bonn	NRW
Germany	Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)	Brühl	NRW
Germany	Fachkrankenhaus Coswig	Coswig	Sachsen
Germany	Gemeinschaftspraxis für Hämatologie & Onkologie	Dortmund	NRW
Germany	Klinikum Dortmund GmbH	Dortmund	NRW
Germany	Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex	Dresden	Sachsen
Germany	Gemeinschaftspraxis Hämatologie - Onkologie	Dresden	Sachsen
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden	Sachsen
Germany	Onkozentrum Dresden/Freiberg/Meißen	Dresden/Freiberg/Meißen	Sachsen
Germany	Universitätsklinikum Düsseldorf (UKD)	Düsseldorf	NRW
Germany	Helios Klinikum Erfurt	Erfurt	Thüringen
Germany	Universitätsklinikum Essen	Essen	NRW
Germany	Onkologische Gemeinschaftspraxis	Gütersloh	NRW
Germany	Praxis für Hämatologie und Internistische Onkologie	Hamm	NRW
Germany	MV-Zentrum für Hämatologie und Onkologie	Köln	NRW
Germany	MVZ West GmbH Standort Köln-Kalk	Köln	NRW
Germany	Praxis Internistischer Onkologie und Hämatologie (pioh)	Köln	NRW
Germany	Universitätsklinikum Köln	Köln	NRW
Germany	Ev. Diakonissenkrankenhaus Leipzig	Leipzig	Sachsen
Germany	Klinikum Leverkusen	Leverkusen	NRW
Germany	Märkische Kliniken GmbH, Klinikum Lüdenscheid	Lüdenscheid	NRW
Germany	Kliniken Maria Hilf GmbH	Mönchengladbach	NRW
Germany	MVZ für Hämatologie und Onkologie	Mülheim an der Ruhr	NRW
Germany	Praxis und Tagesklinik für Internistische Onkologie und Hämatologie	Recklinghausen	NRW
Germany	Krankenhaus Bethanien Solingen	Solingen	NRW
Germany	Onkologie Rheinsieg	Troisdorf/Bonn-Beuel/Bad Honnef	NRW
Germany	Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH	Wesel	NRW
Germany	MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel	Wesel	NRW
Germany	Ambulante Onkologie Ostsachsen	Zittau	Sachsen

Sponsors (16)

Lead Sponsor

Collaborator

University of Cologne

AOK Bundesverband, AOK Nordwest, AOK Rheinland/Hamburg, BARMER, Berlin Institute of Health, Berufsverband der Niedergelassenen Hämatologen und Onkologen in Deutschland e.V., Charite University, Berlin, Germany, Deutsche Krebsgesellschaft e.V., FOM Hochschule für Oekonomie und Management, Gemeinsamer Bundesausschuss (G-BA), Helios Klinikum Emil von Behring, Technische Universität Dresden, University Hospital Carl Gustav Carus, University Hospital, Essen, University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival (OS) will be assessed in months.	up to 34 months
Secondary	Progression-Free Survival (PFS)	Progression-Free Survival (PFS) will be assessed in months.	up to 34 months
Secondary	Time on First Treatment (ToT)	Duration under first-line therapy will be assessed in months.	up to 34 months
Secondary	Hospitalization rate	Frequency of hospital stays will be assessed using health insurance data.	up to 34 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Formative evaluation	Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews	up to 34 months

External Links

•   Project Website