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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
The investigators have chosen to conduct a full factorial experimental design.
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Motivational Interviewing( MI) (Yes vs. No) 		Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session.
  • Behavioral: Motivational Interviewing (MI)
    two counseling sessions
  • Other: saliva sample
    saliva samples from those reporting abstinence and analyze samples
Experimental
Nicotine Replacement Therapy (NRT) Patch (Yes vs. No) 		Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment.
  • Drug: Nicotine Replacement Therapy (NRT)
    receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
  • Other: saliva sample
    saliva samples from those reporting abstinence and analyze samples
Experimental
NRT Lozenge (Yes vs. No) 		Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment.
  • Drug: Nicotine Lozenge
    6 packs of NRT 2mg lozenge
  • Other: saliva sample
    saliva samples from those reporting abstinence and analyze samples
Experimental
Message Framing (Gain vs. Loss) 		Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed).
  • Behavioral: Message Framing
    health communication literature and quitting messages
  • Other: saliva sample
    saliva samples from those reporting abstinence and analyze samples

More Details

Status
Active, not recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.