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

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06484972

ESR-24-22776

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,728 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,728 participants in 2 patient groups

Quality improvement project arm

Description:

The Quality improvement project(QIP) arm will perform QIP intervention. Patients in the QIP arm will be enrolled after about 3-month QIP intervention. The QIP interventions include: establish a coaching committee, quality improvement workshop, implementation of quality improvement measures, as well as evaluation periodically and feedback.

Control arm

Description:

The control arm will not receive intervention and continue with usual care.