Extended Self-Help for Smoking Cessation
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.
- Planned Participants: 1980 daily smokers (for a final sample of at least 1584 after
attrition), recruited via multimedia advertisements (daily and weekly newspapers,
radio, cable television, public transit ads, etc.), public service announcements, and
direct community engagement.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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
Thomas Brandon, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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