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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 850
- 试验地点
- 81
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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))
排除标准
- •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
结局指标
主要结局
Overall Survival (OS)
时间窗: up to 34 months
Overall Survival (OS) will be assessed in months.
次要结局
- Frequency of patients' completing the PROs(up to 34 months)
- Progression-Free Survival (PFS)(up to 34 months)
- Hospitalization rate(up to 34 months)
- Quality of Life (EORTC QLQ-C30)(up to 34 months)
- Symptoms of anxiety (GAD-2)(up to 34 months)
- Symptoms of depression (PHQ-2)(up to 34 months)
- Frequency of applied targeted molecular therapies based on clinical therapy information from the MURIEL database(up to 34 months)
- Cost of implementation related to DigiNet from the service provider perspective (hospital, practices)(up to 34 months)
- Time on First Treatment (ToT)(up to 34 months)
- Frequency of active contact of the expert advisory board with physicians during the course of treatment(up to 34 months)
- Completeness of the documentation of the treatment course(up to 34 months)
- Quality of Life (EORTC QLQ-LC29)(up to 34 months)
- 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](up to 34 months)
- Formative evaluation(up to 34 months)
- Process costs related to DigiNet from the service provider perspective (hospital, practices)(up to 34 months)
研究者
Prof. Dr. Juergen Wolf
Prof. Dr.
University of Cologne