Shared Decision Making + Tobacco Cessation for Lung Cancer

Overseen By Hyewon Shin, NP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Physician Affiliate Group of New York

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Lung cancer continues to be the leading cause of cancer death in the United States. There are several important disparities in lung cancer mortality: racial and ethnic minorities, those with serious mental illness and those with lower socioeconomic status experience higher lung cancer mortality compared to the general population. Lung cancer screening (LCS) with annual low dose chest CT can reduce lung cancer mortality by 20% for high-risk patients, but has been generally underutilized with uptake of 5-15% by eligible patients across the United States. Half of all patients eligible for LCS remain current smokers, and the additional benefits of tobacco cessation services can increase the benefits of LCS clinical encounters in these patients. Despite the proven benefit of LCS and tobacco cessation, it remains out of reach for many with barriers across the patient, provider, and health-care system levels with resultant disparities in uptake of LCS and effective tobacco cessation that may exaggerate disparities in clinical lung cancer early detection and mortality. The majority of LCS care occurs across several visits in an outpatient clinical setting, which may make it inaccessible to the most vulnerable patients. Our central objective is to extend the reach of lung cancer and tobacco screening through the implementation and evaluation of a program extending these services inpatient in a public hospital that serves a known high-risk and diverse population in East Harlem. Preliminary data obtained from a retrospective quality improvement project examined data from patients admitted over a 3 month period in early 2022. Of 1374 unique patients were admitted to our hospital, 112 patients met LCS eligibility criteria and over 80% had no evidence of having been screened. Forty-seven percent identified as Black and 33.9% as Hispanic, groups known to have worse lung cancer outcomes. While smoking data was incomplete on a majority of patients, 75% of all inpatient admissions were noted to be currently smoking. This, our preliminary data suggest that an inpatient program to provide smoking cessation and LCS in a safety-net hospital may be an effective tool to increase the reach of LCS in a known high-risk demographic and address disparities in LCS and tobacco cessation services. This proposal represents a prospective pilot study to develop, implement and evaluate an inpatient LCS and tobacco cessation program.

Eligibility Criteria

This trial is for patients admitted to a public hospital in East Harlem who may be at high risk for lung cancer. It aims to reach diverse populations, including racial and ethnic minorities, those with serious mental illness, or lower socioeconomic status individuals who have been underrepresented in lung cancer screening and tobacco cessation services.

Inclusion Criteria

Greater than or equal to 20 pack year history

I am between 50 and 80 years old.

I am a current smoker or quit smoking within the last 15 years.

Exclusion Criteria

I am under 50 or over 80 years old.

I have smoked less than 20 packs a year.

I quit smoking more than 15 years ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Program Implementation

Implementation and evaluation of an inpatient lung cancer screening and tobacco cessation program

3 months

Inpatient visits during hospital stay

Follow-up

Participants are monitored for up-to-date status on lung cancer screening and smoking cessation

3 months post hospital discharge

Extended Follow-up

Monitoring of lung cancer screening status and smoking cessation outcomes

6 months

Treatment Details

Interventions

• Inpatient Tobacco Cessation Counseling
• Shared decision making for LDCT

Trial Overview The study is testing an inpatient program that offers lung cancer screening (LCS) with low dose chest CT scans and tobacco cessation counseling. The goal is to see if providing these services during a patient's hospital stay can increase LCS uptake among high-risk groups and improve early detection of lung cancer.

Participant Groups

Group I: Meets LCS criteria and former smoker Experimental Treatment 1 Intervention

LDCT on discharge, scheduled date of LDCT, or Lung cancer screening referral

Group II: Meets LCS criteria and active smoker Experimental Treatment 2 Interventions

Inpatient LCS SDM (potential outcomes: 1- LDCT on discharge, 2-scheduled date of LDCT, 3-LCS referral. Along with Inpatient Tobacco Cessation/Reduction Counseling (Handouts, NYC Quits number, medication recommendations to primary team).

Who Is Running the Clinical Trial?

Physician Affiliate Group of New York

Lead Sponsor

Trials

1

Recruited

150+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+