A Multicenter Cluster Randomized Controlled Study to Evaluate Guideline Adoption Through Lung Cancer Clinical Care Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,728
- 主要终点
- Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy
研究概览
简要总结
This is a cluster randomized controlled trial with PCCM department in each site being the cluster. Fifty-four sites' PCCM departments will be randomized to the QIP arm versus control arm in 2:1 allocation ratio. The QIP arm will perform QIP intervention. The control arm will not receive intervention and continue with usual care.
The primary endpoints of this study are molecular testing rate of non-small cell lung cancer (NSCLC) prior to the first systematic anti-tumor therapy, and adjuvant or first line targeted therapy treatment rate in actionable oncogenic alterations (AGA) NSCLC.
详细描述
Approximately 1728 patients from 54 sites will be enrolled (about 30 NSCLC [20%-30% squamous cases] and 2 extensive-stage small-cell lung cancer [ES-SCLC] patients in each site). Patients in the QIP arm will be enrolled after about 3-month QIP intervention. Patients in the control arm will be enrolled as soon as the trial starts. Data on lung cancer diagnosis and treatment pattern will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy
时间窗: Baseline, 3/6/12/21/30 months post enrollment
The percentage of patients with a pathological diagnosis of NSCLC who undertake molecular testing prior to the first systematic anti-tumor therapy in patients with a pathological diagnosis of NSCLC.
Adjuvant or first line targeted therapy treatment rate in AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)
时间窗: Baseline, 3/6/12/21/30 months post enrollment
The percentage of patients with AGA NSCLC who receive adjuvant or first line targeted therapy in patients with AGA NSCLC who receive adjuvant or first line systematic therapy.
次要结局
- ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer)(Baseline, 3/6/12/21/30 months post enrollment)
- DFS(Disease free survival) of NSCLC(Non-small cell lung cancer) who receive neoadjuvant/adjuvant therapy(Baseline, 3/6/12/21/30 months post enrollment)
- First line chemotherapy-immunotherapy treatment rate of ES-SCLC(Extensive-stage small-cell lung cancer) (stage III-IV)(Baseline, 3/6/12/21/30 months post enrollment)
- Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer)(Baseline, 3/6/12/21/30 months post enrollment)
- MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer)(Baseline, 3/6/12/21/30 months post enrollment)
- TNM stage diagnosis rate prior to the first anti-tumor therapy(Baseline)
- Biopsy method(Baseline, 3/6/12/21/30 months post enrollment)
- Spirometry rate(Baseline)
- First line immunotherapy treatment rate in unresectable non-AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)(Baseline, 3/6/12/21/30 months post enrollment)
- ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer)(Baseline, 3/6/12/21/30 months post enrollment)
- PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer)(Baseline, 3/6/12/21/30 months post enrollment)
- PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer)(Baseline, 3/6/12/21/30 months post enrollment)
研究者
Wang Chen
Director of the National Center for Respiratory Medicine
China-Japan Friendship Hospital