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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA207228-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hackensack Meridian Health | OTHER |
| Baptist Health South Florida | OTHER |
| Lahey Hospital & Medical Center | OTHER |
| University of Michigan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Telephone Counseling | Experimental | 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. |
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| Usual Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Telephone Counseling (8 sessions) with nicotine replacement | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment; |
| Measure | Description | Time Frame |
|---|---|---|
| Readiness to quit | Measured using the 10-point contemplation ladder. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| Baptist Health South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31129371 | Background | Taylor KL, Deros DE, Fallon S, Stephens J, Kim E, Lobo T, Davis KM, Luta G, Jayasekera J, Meza R, Stanton CA, Niaura RS, Abrams DB, McKee B, Howell J, Ramsaier M, Batlle J, Dornelas E, Parikh V, Anderson E. Study protocol for a telephone-based smoking cessation randomized controlled trial in the lung cancer screening setting: The lung screening, tobacco, and health trial. Contemp Clin Trials. 2019 Jul;82:25-35. doi: 10.1016/j.cct.2019.05.006. Epub 2019 May 23. | |
| 33484569 |
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Deidentified patient data will be shared with the National Cancer Institute as part of the SCALE collaboration.
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| OTHER |
| National Cancer Institute (NCI) | NIH |
| Unity Point Health | OTHER |
| MedStar Shah Medical Group | UNKNOWN |
| Anne Arundel Medical Center | INDIV |
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| Usual Care: Telephone counseling (3 sessions) with nicotine replacement | Behavioral | Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches. |
|
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.
| 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. | 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) | 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 | Through study completion, an average of 3 months post-randomization. |
| Cigarettes smoked per day | Number of cigarettes per day | 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) |
| Miami |
| Florida |
| 33176 |
| United States |
| UnityPoint Health --Trinity Medical Center | Moline | Illinois | 61265 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| MedStar Shah Medical Group | Hollywood | Maryland | 20636 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Cadham CJ, Cao P, Jayasekera J, Taylor KL, Levy DT, Jeon J, Elkin EB, Foley KL, Joseph A, Kong CY, Minnix JA, Rigotti NA, Toll BA, Zeliadt SB, Meza R, Mandelblatt J; CISNET-SCALE Collaboration. Cost-Effectiveness of Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Simulation Study. J Natl Cancer Inst. 2021 Aug 2;113(8):1065-1073. doi: 10.1093/jnci/djab002. |
| 31446996 | Background | Cadham CJ, Jayasekera JC, Advani SM, Fallon SJ, Stephens JL, Braithwaite D, Jeon J, Cao P, Levy DT, Meza R, Taylor KL, Mandelblatt JS; CISNET-SCALE Collaboration. Smoking cessation interventions for potential use in the lung cancer screening setting: A systematic review and meta-analysis. Lung Cancer. 2019 Sep;135:205-216. doi: 10.1016/j.lungcan.2019.06.024. Epub 2019 Jul 6. |
| 35818122 | Result | Taylor KL, Williams RM, Li T, Luta G, Smith L, Davis KM, Stanton CA, Niaura R, Abrams D, Lobo T, Mandelblatt J, Jayasekera J, Meza R, Jeon J, Cao P, Anderson ED; Georgetown Lung Screening, Tobacco, and Health Trial. A Randomized Trial of Telephone-Based Smoking Cessation Treatment in the Lung Cancer Screening Setting. J Natl Cancer Inst. 2022 Oct 6;114(10):1410-1419. doi: 10.1093/jnci/djac127. |
| 35818125 | Result | Cao P, Smith L, Mandelblatt JS, Jeon J, Taylor KL, Zhao A, Levy DT, Williams RM, Meza R, Jayasekera J. Cost-Effectiveness of a Telephone-Based Smoking Cessation Randomized Trial in the Lung Cancer Screening Setting. JNCI Cancer Spectr. 2022 Jul 1;6(4):pkac048. doi: 10.1093/jncics/pkac048. |
| 35448154 | Result | Williams RM, Eyestone E, Smith L, Philips JG, Whealan J, Webster M, Li T, Luta G, Taylor KL, On Behalf Of The Lung Screening Tobacco Health Trial. Engaging Patients in Smoking Cessation Treatment within the Lung Cancer Screening Setting: Lessons Learned from an NCI SCALE Trial. Curr Oncol. 2022 Mar 23;29(4):2211-2224. doi: 10.3390/curroncol29040180. |
| 35143041 | Result | Williams RM, Cordon M, Eyestone E, Smith L, Luta G, McKee BJ, Regis SM, Abrams DB, Niaura RS, Stanton CA, Parikh V, Taylor KL; Lung Screening, Tobacco, Health Trial. Improved motivation and readiness to quit shortly after lung cancer screening: Evidence for a teachable moment. Cancer. 2022 May 15;128(10):1976-1986. doi: 10.1002/cncr.34133. Epub 2022 Feb 10. |
| 34077535 | Result | Eyestone E, Williams RM, Luta G, Kim E, Toll BA, Rojewski A, Neil J, Cinciripini PM, Cordon M, Foley K, Haas JS, Joseph AM, Minnix JA, Ostroff JS, Park E, Rigotti N, Sorgen L, Taylor KL. Predictors of Enrollment of Older Smokers in Six Smoking Cessation Trials in the Lung Cancer Screening Setting: The Smoking Cessation at Lung Examination (SCALE) Collaboration. Nicotine Tob Res. 2021 Nov 5;23(12):2037-2046. doi: 10.1093/ntr/ntab110. |
| 33964415 | Result | Kim E, Williams RM, Eyestone E, Cordon M, Smith L, Davis K, Luta G, Anderson ED, McKee B, Batlle J, Ramsaier M, Howell J, Parikh V, Geronimo M, Stanton C, Niaura R, Abrams D, Taylor KL; Lung Screening, Tobacco and Health Trial. Predictors of attrition in a smoking cessation trial conducted in the lung cancer screening setting. Contemp Clin Trials. 2021 Jul;106:106429. doi: 10.1016/j.cct.2021.106429. Epub 2021 May 6. |
| 33868901 | Result | Cordon M, Eyestone E, Hutchison S, Dunlap D, Smith L, Williams RM, Kim E, Kao JY, Hurtado-de-Mendoza A, Stanton C, Davis K, Frey J, McKee B, Parikh V, Taylor KL; Lung Screening, Tobacco, and Health Study. A qualitative study exploring older smokers' attitudes and motivation toward quitting during the COVID-19 pandemic. Prev Med Rep. 2021 Mar 11;22:101359. doi: 10.1016/j.pmedr.2021.101359. eCollection 2021 Jun. |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D015438 | Health Behavior |
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