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
NCT Number: NCT06484972
Acronym: LC PCCM QIP
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1728
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-27
Completion Date: 2028-03-31

Summary:
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.

Primary Outcome Measures: Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy, 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., Baseline, 3/6/12/21/30 months post enrollment|Adjuvant or first line targeted therapy treatment rate in AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer), 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., Baseline, 3/6/12/21/30 months post enrollment
Secondary Outcome Measures: TNM stage diagnosis rate prior to the first anti-tumor therapy, The percentage of patients with clinical TNM staging diagnosis before first anti-tumor treatment of lung cancer in patients with first anti-tumor treatment of lung cancer., Baseline|Biopsy method, Describe the pathological biopsy method of lung cancer patients, including but not limited to bronchoscopy biopsy rate, percutaneous lung biopsy rate, thoracoscopic lung biopsy rate, etc., Baseline, 3/6/12/21/30 months post enrollment|Spirometry rate, The percentage of patients with lung cancer who perform spirometry in patients with lung cancer., Baseline|First line immunotherapy treatment rate in unresectable non-AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer), The percentage of patients with unresectable non-AGA NSCLC who receive first line immunotherapy in patients with unresectable non-AGA NSCLC who receive the first systematic 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), The percentage of patients with ES-SCLC (stage III-IV) who receive first line chemotherapy-immunotherapy in patients with ES-SCLC (stage III-IV) who receive the first systematic therapy., Baseline, 3/6/12/21/30 months post enrollment|Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer), The percentage of patients with stage I-IIIA NSCLC who undergo surgical resection in patients with stage I-IIIA NSCLC., Baseline, 3/6/12/21/30 months post enrollment|MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer), The percentage of patients with stage IIIB-IV NSCLC discussed at the MDT meeting in patients with stage IIIB-IV NSCLC., Baseline, 3/6/12/21/30 months post enrollment|ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer), ORR will be defined as the proportion of patients who achieved BOR of a CR or PR assessed by pulmonologists., Baseline, 3/6/12/21/30 months post enrollment|ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer), ORR will be defined as the proportion of patients who achieved BOR of a CR or PR assessed by pulmonologists., Baseline, 3/6/12/21/30 months post enrollment|PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer), PFS will be defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first., Baseline, 3/6/12/21/30 months post enrollment|PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer), PFS will be defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first., 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, DFS will be defined as the time from surgery to recurrence of tumor or death for any cause, whichever occurs first., Baseline, 3/6/12/21/30 months post enrollment