A Phase 3 interventional study of Intensive Telephone Counseling (8 sessions) with nicotine replacement and Usual Care: Telephone counseling (3 sessions) with nicotine replacement in Smoking, Tobacco, Tobacco-Related Carcinoma and Tobacco Use, sponsored by Georgetown University. Completed at 7 sites in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Georgetown University · Phase 3, Interventional, and Prevention
The purpose of this study is to compare intensive telephone counseling (ITC) plus the nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC) among current smokers undergoing lung cancer screening. Smoking-related outcomes will be examined at three, six and twelve months post-randomization.
The investigators have built on the evidence-base of telephone counseling for smoking cessation. This pragmatic approach is designed at the intersection of scalability and intensity, for future implementation within the national tobacco quitline. In collaboration with five geographically and ethnically diverse lung cancer screening programs, the investigators will accrue smokers who have registered for screening,and are at all levels of readiness to quit. Prior to the screening day, the investigators will conduct the baseline (T0) phone interview. Following participants' receipt of their screening result (one week post-screening), the investigators will complete the T1 phone interview, provide brief advice to quit and conduct randomization. Participants will be randomized into one of two groups: ITC, in which participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine patches. ITC will include a discussion of screening results throughout counseling sessions. The UC arm will include up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine patches. UC will not include a discussion of screening results throughout counseling sessions. All sessions will be conducted by a Tobacco Treatment Specialist (English or Spanish) and the investigators will assess intervention fidelity. In both groups, the investigators will engage referring physicians by notifying them of their patients' study enrollment and of their patients' smoking status at the 6-month follow-up. The 3-month (T2), 6-month (T3), and 12-month (T4) assessments will assess readiness to quit, quit attempts, 7-day and 30-day abstinence verified by Nicalert or carbon monoxide testing, and intervention process variables. Furthermore, two important aspects of this approach include a cost-effectiveness analysis and use of the Cancer Intervention and Surveillance Modeling Network (CISNET) to evaluate the cost of the interventions relative to their impact on short- and long-term smoking-related outcomes.
The aims are:
This study's strengths include the assessment of effective cessation methods designed for widespread implementation, novel components based on unique features of screening, cost-effectiveness analyses, and leveraging the University of Michigan CISNET model to project the population impact of implementing an effective cessation intervention in lung screening programs. The overall goal is to have a substantial public health impact by providing critical data to address scalability efforts by screening centers, insurers, and policy-makers.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 1,114 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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Exclusion Criteria:
This arm provides a multi-faceted, 8-session intensive telephone counseling (ITC) protocol, tailored on lung cancer screening results, with 8-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.
Behavioral: Intensive Telephone Counseling (8 sessions) with nicotine replacement
This arm provides a multi-faceted, 3-session usual care telephone counseling (UC) protocol, with 2-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.
Behavioral: Usual Care: Telephone counseling (3 sessions) with nicotine replacement
Participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine replacement patches. A counselor-initiated discussion of screening results will also be included throughout the counseling sessions.
Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.
Smoking cessation rate at 3-months post-randomization
Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).
Time frame: Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months.
Smoking cessation rate at 6-months post-randomization
Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).
Time frame: Self-report measured at 6-months post-randomization; biochemical verification measured at 6-months.
Smoking cessation rate at 12-months post-randomization
Comparison between study arms of 7-day and 30-day point prevalence cessation. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).
Time frame: Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment;
Readiness to quit
Measured using the 10-point contemplation ladder.
Time frame: Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), and 3-months (T2), 6-months (T3), and 12-months post-randomization (T4).
Quit attempts
The investigators will assess the number and length of prior quit attempts at baseline. At all follow-up assessments, the investigators will assess the number and length of quit attempts that have occurred since the previous assessment.
Time frame: Baseline (T0), 1-2 days post-receipt of screening result (T1),3-, 6- and 12- months post-randomization (T2, T3, T4)
TC intervention fidelity
Measurement of counselor adherence to the TC protocol, which will be assessed on 10% of randomly selected participants.
Time frame: Through study completion, an average of 3 months post-randomization.
Patient reach and patient engagement
Reach: % of eligible smokers enrolled in trial; Engagement: % who receive the TC and the nicotine patch interventions), both overall and among subgroups (gender, age, nicotine dependence, site)
Time frame: Through study completion, an average of 3 months post-randomization.
Costs per arm for study outcomes
Patient time costs in the interventions; fixed costs (space, overhead) and variable costs (intervention delivery and patient participation) by arm
Time frame: Through study completion, an average of 3 months post-randomization.
Cigarettes smoked per day
Number of cigarettes per day
Time frame: Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), 3-months post-randomization (T2), 6 months post randomization (T3) and 12 months post randomization (T4)
Plan to share: Yes — Deidentified patient data will be shared with the National Cancer Institute as part of the SCALE collaboration.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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