Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatment forever free booklets
Phase phase 2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator National Cancer Institute (NCI)
Start date January 2009
End date April 2017
Trial size 2124 participants
Trial identifier NCT01352195, MCC-15724

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
This condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003).
forever free booklets
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.
(Active Comparator)
Stand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies.
forever free booklets
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.
(Active Comparator)
Inten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts.
forever free booklets
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.

Primary Outcomes

Measure
7-Day Point-Prevalence Abstinence at Each Follow-up Point
time frame: 30 months per participant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Extended Self-Help for Smoking Cessation
Principal investigator Thomas Brandon, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.