Recruiting

Observational Study

Sponsor:

Physician Affiliate Group of New York

Code:

NCT06876831

Conditions

Lung Cancer Screening Program

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Shared decision making for LDCT (3 potential outcomes LDCT on discharge, scheduled date of LDCT, or Lung Cancer Screening referral)

Inpatient Tobacco Cessation Counseling (Handouts, NYC Quits number, Medication Recommendations to primary team, Smoking cessation referral)

Study Details

Brief summary:

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.

Conditions

Lung Cancer Screening Program

Study ID

NCT06876831

Start date

Mar 10, 2025

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Sep 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 50-80 years of age
  • greater than or equal to 20 pack year history
  • currently smoking or have quit within the last 15 years

Exclusion Criteria:

  • < 50 years of age, > 80 years of age
  • < 20 pack year history
  • quit smoking greater than 15 years

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Meets LCS criteria and former smoker

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

experimental: Meets LCS criteria and active smoker

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).

Interventions

Shared decision making for LDCT (3 potential outcomes LDCT on discharge, scheduled date of LDCT, or Lung Cancer Screening referral)

These interventions will be facilitated as an inpatient

Inpatient Tobacco Cessation Counseling (Handouts, NYC Quits number, Medication Recommendations to primary team, Smoking cessation referral)

Active smokers only will received inpatient tobacco cessation counseling/risk reduction

Primary outcome measure

  • up-to-date status on LCS at 3 months of hospital discharge [ Time Frame: 3 months post hospital discharge ]

Central Contacts and Locations

Central contacts

Locations

Metropolitan Hospital/ NYCHHC

Recruiting

New York, New York, United States, 11362

Contacts

Natoushka Trenard, MD, MPH

9548025735trenardn@nychhc.org

Hyewon Shin, NP

Hyewon.Shin@nychhc.org

Principal Investigator:

Natoushka Trenard, MD, MPH

More Information

Sponsor

Physician Affiliate Group of New York

Last update posted

Mar 14, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Physician Affiliate Group of New York on 2025-03-14.