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NCT03315910 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
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