Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Motivational Interviewing (MI); Other: saliva sample; Drug: Nicotine Replacement Therapy (NRT); Drug: Nicotine Lozenge; Behavioral: Message Framing

• Study Type: Interventional
• Enrollment (Actual): 807
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yuelin Li, PhD; Phone Number: 646-888-0047
• Study Contact Backup: Name: Jamie Ostroff, PhD; Phone Number: 646-888-0041; Email: ostroffj@mskcc.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Walnut Creek, California, United States, 94598
      • John Muir Health
  • Georgia
    • LaGrange, Georgia, United States, 30240
      • WellStar Health System
  • Illinois
    • Chicago, Illinois, United States, 606012
      • Rush University Medical Center
    • Kankakee, Illinois, United States, 60901
      • Riverside Healthcare
  • Indiana
    • Crown Point, Indiana, United States, 46307
      • St. Mary Medical Center, Community Healthcare System
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • MercyOne Des Moines Medical Center (Data Collection Only)
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital (Data collection only)
    • Traverse City, Michigan, United States, 49684
      • Munson Healthcare
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center (Data Collection Only)
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
  • North Carolina
    • Morganton, North Carolina, United States, 28655
      • Carolinas Healthcare System Blue Ridge
  • Ohio
    • Lancaster, Ohio, United States, 43130
      • Fairfield Medical Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: saliva sample; saliva samples from those reporting abstinence and analyze samples; Drug: Nicotine Replacement Therapy (NRT); receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
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.	Other: saliva sample; saliva samples from those reporting abstinence and analyze samples; Drug: Nicotine Lozenge; 6 packs of NRT 2mg lozenge
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).	Other: saliva sample; saliva samples from those reporting abstinence and analyze samples; Behavioral: Message Framing; health communication literature and quitting messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jamie Ostroff, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Ostroff JS, Shelley DR, Chichester LA, King JC, Li Y, Schofield E, Ciupek A, Criswell A, Acharya R, Banerjee SC, Elkin EB, Lynch K, Weiner BJ, Orlow I, Martin CM, Chan SV, Frederico V, Camille P, Holland S, Kenney J. Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings. Trials. 2022 Aug 17;23(1):664. doi: 10.1186/s13063-022-06568-3.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cancer Screening; Tobacco Treatment; Lung CT; 17-500
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 17-500

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No