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Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03315910
Enrollment
807
Registered
2017-10-20
Start date
2017-10-10
Completion date
2026-10-31
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Tobacco Treatment, Lung CT, Cancer Screening, 17-500

Brief 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.

Interventions

BEHAVIORALMotivational Interviewing (MI)

two counseling sessions

DRUGNicotine Replacement Therapy (NRT)

receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day

DRUGNicotine Lozenge

6 packs of NRT 2mg lozenge

BEHAVIORALMessage Framing

health communication literature and quitting messages

OTHERsaliva sample

saliva samples from those reporting abstinence and analyze samples

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The investigators have chosen to conduct a full factorial experimental design.

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
number of patients who are tobacco abstinence6 months following study enrollmentbiochemical 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026