Status:
NOT_YET_RECRUITING
A Study to Evaluate Guideline Adoption Through Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department
Lead Sponsor:
China-Japan Friendship Hospital
Collaborating Sponsors:
AstraZeneca
Conditions:
Lung Cancer
Eligibility:
All Genders
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 alloca...
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 Q...
Eligibility Criteria
Inclusion
- 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 ".
- 1.3 PCCM department who want to improve lung cancer healthcare quality and agree to participate in study.
- 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.
- 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.
- 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 Participating in another interventional clinical study.
Exclusion
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
1728 Patients enrolled
Trial Details
Trial ID
NCT06484972
Start Date
March 1 2025
End Date
March 31 2028
Last Update
January 28 2025
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