Extended Self-Help for Smoking Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-23

Study Completion Date

2014-08-27

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.

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual Care (UC)

This condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003).

Group Type ACTIVE_COMPARATOR

Forever Free Booklets

Intervention Type BEHAVIORAL

Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.

Standard Repeated Mailings (Stand-RM)

Stand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies.

Group Type ACTIVE_COMPARATOR

Forever Free Booklets

Intervention Type BEHAVIORAL

Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.

Intensive Repeated Mailings (Inten-RM)

Inten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts.

Group Type ACTIVE_COMPARATOR

Forever Free Booklets

Intervention Type BEHAVIORAL

Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.

Interventions

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Forever Free Booklets

Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)