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In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment.
In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment (self-reported smoking abstinence using imputation for missing data).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 wk assessment + TLC monthly | Active Comparator | 4 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) |
|
| 4 week assessment + TLC quarterly | Active Comparator | 4 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) |
|
| 4 week assessment +TLC + MTM | Active Comparator | 4 week assessment, 4 weeks counseling, NRT, medication management (nonresponders) |
|
| 8 week assessment + TLC monthly | Active Comparator | 8 week assessment, 8 weeks of counseling, NRT, monthly follow-up (responders) |
|
| 8 week assessment + TLC quarterly | Active Comparator | 8 week assessment, 8 weeks of counseling, NRT, quarterly follow-up (responders) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLC monthly | Behavioral | Tobacco longitudinal care monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 months prolonged abstinence from smoking, measured 18M after randomization | The primary (dichotomous) outcome for all analyses will be whether or not smokers achieve 6-month prolonged abstinence measured at 18 months after the baseline assessment. All analyses will be by intention-to-treat, and include all participants randomized to intervention, regardless of whether they are lost to follow-up. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Joseph, MD | University of Minnesota | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12745503 | Background | Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25. | |
| 37615989 | Derived | Fu SS, Rothman AJ, Vock DM, Lindgren BR, Almirall D, Begnaud A, Melzer AC, Schertz KL, Branson M, Haynes D, Hammett P, Joseph AM. Optimizing Longitudinal Tobacco Cessation Treatment in Lung Cancer Screening: A Sequential, Multiple Assignment, Randomized Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329903. doi: 10.1001/jamanetworkopen.2023.29903. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2021 | Aug 4, 2021 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| 8 week assessment + TLC + MTM | Active Comparator | 8 week assessment, 8 weeks counseling, NRT, medication management (nonresponders) |
|
| TLC quarterly | Behavioral | Tobacco longitudinal care quarterly |
|
| MTM | Behavioral | Medication management therapy |
|
| 4 week assessment | Behavioral | 4 week assessment |
|
| 8 week assessment | Behavioral | 8 week assessment |
|
| 28687349 | Derived | Fu SS, Rothman AJ, Vock DM, Lindgren B, Almirall D, Begnaud A, Melzer A, Schertz K, Glaeser S, Hammett P, Joseph AM. Program for lung cancer screening and tobacco cessation: Study protocol of a sequential, multiple assignment, randomized trial. Contemp Clin Trials. 2017 Sep;60:86-95. doi: 10.1016/j.cct.2017.07.002. Epub 2017 Jul 4. No abstract available. |