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Not yet recruiting NCT06484972

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

— Observational Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Primary outcome measures

  • Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy [Time frame: 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) [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
Secondary outcome measures (12)
  • TNM stage diagnosis rate prior to the first anti-tumor therapy [Time frame: Baseline]
  • Biopsy method [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
  • Spirometry rate [Time frame: Baseline]
  • First line immunotherapy treatment rate in unresectable non-AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer) [Time frame: 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) [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
  • Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer) [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
  • MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer) [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
  • ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer) [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
  • ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer) [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
  • PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer) [Time frame: Baseline, 3/6/12/21/30 months post enrollment]
  • PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer) [Time frame: 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 [Time frame: Baseline, 3/6/12/21/30 months post enrollment]

Eligibility criteria

  • 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.

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06484972 · ESR-24-22776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗