Smoking Cessation
Conditions
Keywords
Forever Free
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALForever Free Booklets
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.
Sponsors
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants: * 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. Inclusion Criteria: * smoking at least five cigarette per day over the past year * not currently enrolled in a face-to-face smoking cessation program * able to speak and read English * desire to quit smoking, as indicated by a score of at least 5 (Think I should quit, but not quite ready) on the Contemplation Ladder (Biener & Abrams, 1991)
Exclusion criteria
* number of participants from the same street address limited to 1 * no more than 2 referrals per participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point-Prevalence Abstinence at Each Follow-up Point | 30 months per participant | 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. |
Countries
United States
Outcome results
None listed