Clinical trial NCT06484972: A Study to Evaluate Guideline Adoption Through Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2024-07-03
Enrollment: 1728
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pulmonologists in PCCM(Pulmonary and Critical Care Medicine).

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.

Eligibility criteria: 1. Cluster 1.1 Cluster inclusion criteria 1.1.1 PCCM department in Tier 3 hospital. 1.1.2 PCCM department's standardized construction certification is "qualified ".

   1.1.3 PCCM department who want to improve lung cancer healthcare quality and agree to participate in study.

   1.2 Cluster exclusion criteria 1.2.1 PCCM department does not carry out anti-tumor treatment for lung cancer. 1.2.2 PCCM department participant in other lung cancer quality improvement study.
2. Individual Patient 2.1 Individual inclusion criteria 2.1.1 Pathology diagnosed NSCLC or ES-SCLC. 2.1.2 No prior systematic anti-tumor therapy, or prior adjuvant and neo-adjuvant therapies, definitive radiation/chemoradiation are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.

2.1.3 Performance score (PS) 0-2. 2.1.4 Life expectancy \>12 weeks. 2.2 Individual exclusion criteria 2.2.1 Have a plan to transfer to other hospitals to receive anti-tumor therapy within 3 months after signing the ICF.

2.2.2 Participating in another interventional clinical study.

Primary outcomes:
measure: Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: Adjuvant or first line targeted therapy treatment rate in AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
Secondary outcomes:
measure: TNM stage diagnosis rate prior to the first anti-tumor therapy
timeFrame: Baseline
measure: Biopsy method
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: Spirometry rate
timeFrame: Baseline
measure: First line immunotherapy treatment rate in unresectable non-AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: First line chemotherapy-immunotherapy treatment rate of ES-SCLC(Extensive-stage small-cell lung cancer) (stage III-IV)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer)
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
measure: DFS(Disease free survival) of NSCLC(Non-small cell lung cancer) who receive neoadjuvant/adjuvant therapy
timeFrame: Baseline, 3/6/12/21/30 months post enrollment
Other outcomes:
Locations:
Study officials:
References: