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

Disqualifiers: Age, Smoking history, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve lung cancer screening and assist people in quitting smoking, focusing on high-risk groups. It aims to provide these services directly to patients in the hospital, facilitating access for those who might not otherwise have it. The trial targets current smokers or those who quit within the last 15 years and have a history of heavy smoking. Participants will receive support for lung cancer screening through shared decision-making for LDCT (low-dose computed tomography) and smoking cessation. This approach could benefit individuals who struggle to access regular outpatient care. As an unphased trial, the study offers a unique opportunity to contribute to innovative approaches in lung cancer prevention and smoking cessation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program is safe for patients?

Research has shown that discussing low-dose CT scans for lung cancer screening with a doctor is generally safe. Patients who discussed screening with their doctor were more likely to undergo the recommended tests, indicating that this approach keeps patients engaged without additional safety concerns.

For quitting smoking, studies have found that combining stop-smoking support with lung cancer screening is effective. Smokers who received counseling were more likely to quit, demonstrating that the counseling is both safe and beneficial.

Overall, both discussing low-dose CT scans with a doctor and receiving support to quit smoking are safe and effective for individuals at risk of lung cancer. No major issues have been reported with these methods, making them good options for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach combining shared decision-making with tobacco cessation strategies for lung cancer screening. Unlike standard methods that typically focus on either screening or smoking cessation separately, this trial integrates both by providing personalized counseling and direct resources for smoking cessation alongside low-dose computed tomography (LDCT) screening. This could lead to a more holistic approach to lung cancer prevention, potentially improving patient outcomes by addressing both early detection and smoking cessation in a coordinated manner. By empowering patients to actively participate in their screening decisions and providing tailored support for quitting smoking, the trial aims to enhance patient engagement and adherence to recommended health behaviors.

What evidence suggests that this trial's treatments could be effective for lung cancer and tobacco cessation?

Research has shown that when patients and doctors make decisions together, participation in lung cancer screening increases significantly. In this trial, some participants will engage in shared decision-making for low-dose computed tomography (LDCT) screening. This approach helps patients understand the benefits and risks, leading to more informed choices. It has been shown to increase the likelihood of continuing with regular screenings.

For participants who are active smokers, the trial includes inpatient tobacco cessation counseling, which has proven effective in helping people quit smoking. Studies indicate that these interventions can improve lung health and lower death rates. Both strategies aim to improve lung cancer outcomes, especially for those at high risk. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39804633/

Smoking Cessation Interventions in the Lung Cancer ... IC outperformed both QL (odds ratio [OR], 1.75 [95% CI, 1.15-2.66]; P = .01) and QL+ (OR, 1.58 [95% CI, 1.05-2.40]; P = .03). At 6 months, IC ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2808739

Optimizing Longitudinal Tobacco Cessation Treatment in ... The current study reports the main results of the Program for Lung Cancer Screening and Tobacco Cessation (PLUTO) trial.

3. jto.org jto.org/article/S1556-0864(25)00175-3/fulltext

Reducing Lung Cancer Mortality by Providing Smoking ... SCS delivered in the LCS setting can considerably reduce lung cancer mortality, with the potential to reduce global, racial, economic, and geographic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1556086423023687

Effect of a Personalized Tobacco Treatment Intervention on ... Gain-framed messaging and health feedback did not significantly improve quit rates relative to comprehensive standard of care.

5. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)05878-6/fulltext

Update on the National Cancer Institute's Smoking Cessation ... Results were published in 2023. Average cessation rates, measured by self-report and validated biochemically at 6 months, improved over time (0% at baseline to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03276806

Inpatient Smokers and LDCT Screening RCT Current smokers who undergo annual low dose CT (LDCT) lung cancer screening and successfully quit smoking derive the greatest reduction in lung cancer ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4828323/

Pairing Smoking-Cessation Services With Lung Cancer ... Styn and colleagues also observed that 1-year quit rates were significantly higher among smokers (N = 2094) who received positive scan results (18% vs 7%).

8. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525002037

Provider readiness and implementation barriers for lung ... This study assessed provider knowledge, attitudes, and readiness to implement LCS, including shared decision-making (SDM) and smoking cessation, within a large ...

9. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.35972

The American Cancer Society National Lung Cancer ... Tobacco treatment at the time of lung cancer screening results review. Several studies have integrated TT counseling during the postscreening ...