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The trial is taking place at:

Charité Universitätsmedizin Berlin | Deutsches Herzzentrum der Charité - Studienzentrale

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

U

University of Cologne

Status

Active, not recruiting

Conditions

Non-small Cell Lung Cancer Stage IV

Treatments

Other: DigiNet intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05818449
01NVF20021

Details and patient eligibility

About

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.

Full 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.

Enrollment

850 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

850 participants in 2 patient groups

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

Trial contacts and locations

41

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Central trial contact

Anna Kron, Dr.; Leonie Eilers, MSc

Data sourced from clinicaltrials.gov

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