A Study to Evaluate Guideline Adoption Through Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department

Not yet recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06484972
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Study Start: 2025-03-01
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1728

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy	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)	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.

Secondary Outcome Measures

Name	Time	Method
ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer)	Baseline, 3/6/12/21/30 months post enrollment	ORR will be defined as the proportion of patients who achieved BOR of a CR or PR assessed by pulmonologists.
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	DFS will be defined as the time from surgery to recurrence of tumor or death for any cause, whichever occurs first.
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	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.
Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer)	Baseline, 3/6/12/21/30 months post enrollment	The percentage of patients with stage I-IIIA NSCLC who undergo surgical resection in patients with stage I-IIIA NSCLC.
MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer)	Baseline, 3/6/12/21/30 months post enrollment	The percentage of patients with stage IIIB-IV NSCLC discussed at the MDT meeting in patients with stage IIIB-IV NSCLC.
TNM stage diagnosis rate prior to the first anti-tumor therapy	Baseline	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.
Biopsy method	Baseline, 3/6/12/21/30 months post enrollment	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.
Spirometry rate	Baseline	The percentage of patients with lung cancer who perform spirometry in patients with lung cancer.
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	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.
ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer)	Baseline, 3/6/12/21/30 months post enrollment	ORR will be defined as the proportion of patients who achieved BOR of a CR or PR assessed by pulmonologists.
PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer)	Baseline, 3/6/12/21/30 months post enrollment	PFS will be defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first.
PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer)	Baseline, 3/6/12/21/30 months post enrollment	PFS will be defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first.