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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The primary purpose of this study is smoking cessation. The investigators are conducting a research study to learn how well the information from the program helps participants to quit smoking and remain smoke-free.
The investigators propose a randomized 3-arm design, with 660 smokers recruited into each condition. The three conditions will include: (1) Usual care (UC), which will comprise a single smoking cessation booklet developed by NCI; (2) Standard Repeated Mailings (Stand-RM), which will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies; and (3) Intensive Repeated Mailings (Inten-RM), which will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. Assessments will occur at six-month intervals, through 30 months. An overview of the design is depicted in Table 4, which will be referenced throughout the remainder of this proposal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (UC) | Active Comparator | This condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003). |
|
| Standard Repeated Mailings (Stand-RM) | Active Comparator | Stand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies. |
|
| Intensive Repeated Mailings (Inten-RM) | Active Comparator | Inten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forever Free Booklets | Behavioral | Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Point-Prevalence Abstinence at Each Follow-up Point | Time will be measured in months from the start of condition. Potential confounding variables (e.g., group differences in demographic, smoking history, or pharmacotherapy use) will be adjusted for in the model. Pair-wise condition and time interval comparisons will be tested using the generalized score statistics from generalized estimating equations (GEE) models by utilizing the contrast statements. | 30 months per participant |
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Participants:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Brandon, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26868284 | Derived | Brandon TH, Simmons VN, Sutton SK, Unrod M, Harrell PT, Meade CD, Craig BM, Lee JH, Meltzer LR. Extended Self-Help for Smoking Cessation: A Randomized Controlled Trial. Am J Prev Med. 2016 Jul;51(1):54-62. doi: 10.1016/j.amepre.2015.12.016. Epub 2016 Feb 8. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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