Extended Self-Help for Smoking Cessation

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Forever Free Booklets

• Registration Number: NCT01352195
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Timeline

• Study Start: 2009-01-23
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2014-02-18
• Study Completion: 2014-08-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Repeated Mailings (Inten-RM)	Forever Free Booklets	Inten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts.
Standard Repeated Mailings (Stand-RM)	Forever Free Booklets	Stand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies.
Usual Care (UC)	Forever Free Booklets	This condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States