Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Smoking Cessation Clinical Trial

Official title:

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03315910
• Other study ID #: 17-500
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 10, 2017
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 807
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

Site Eligibility (as per SC self-report)

& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site

• Reports at least one year of lung cancer screening experience

• Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)

• Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)

• Between the ages of 50-80 years old

• Seeking baseline or annual follow-up LDCT lung cancer screening

• Have at least a 20 pack-year history of smoking

• Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.

• Must be reachable by telephone

• Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.

Exclusion Criteria:

Patient (as per self-report)

• NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).

• Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Motivational Interviewing (MI)
two counseling sessions

Drug:
• Nicotine Replacement Therapy (NRT)
receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
• Nicotine Lozenge
6 packs of NRT 2mg lozenge

Behavioral:
• Message Framing
health communication literature and quitting messages

Other:
• saliva sample
saliva samples from those reporting abstinence and analyze samples

Locations

Country	Name	City	State
United States	Montefiore Medical Center (Data Collection Only)	Bronx	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	St. Mary Medical Center, Community Healthcare System	Crown Point	Indiana
United States	MercyOne Des Moines Medical Center (Data Collection Only)	Des Moines	Iowa
United States	Henry Ford Hospital (Data collection only)	Detroit	Michigan
United States	Riverside Healthcare	Kankakee	Illinois
United States	WellStar Health System	LaGrange	Georgia
United States	Fairfield Medical Center	Lancaster	Ohio
United States	University of Southern California	Los Angeles	California
United States	NYU Winthrop Hospital	Mineola	New York
United States	Carolinas Healthcare System Blue Ridge	Morganton	North Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	Legacy Health	Portland	Oregon
United States	Maine Medical Center Cancer Institute	Scarborough	Maine
United States	Munson Healthcare	Traverse City	Michigan
United States	John Muir Health	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who are tobacco abstinence	biochemical verification of smoking abstinence will be conducted Consistent with Intent to Treat, unless self reported smoking abstinence is biochemically verified, (<3 ng/ml for mailed salivary cotinine assay) for participants who fail to return the saliva sample, the cessation outcome will be considered non-abstinent.	6 months following study enrollment

External Links

•   Memorial Sloan Kettering Cancer Center