Extended Self-Help for Smoking Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Extended Self-Help for Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Forever Free Booklets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care (UC)<br>This condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003). | Behavioral: Forever Free Booklets<br>* Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.<br>|
| Active Comparator: Standard Repeated Mailings (Stand-RM)<br>Stand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies. | Behavioral: Forever Free Booklets<br>* Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.<br>|
| Active Comparator: Intensive Repeated Mailings (Inten-RM)<br>Inten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. | Behavioral: Forever Free Booklets<br>* Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forever Free