Extended Self-Help for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Extended Self-Help for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352195
• Other study ID #: MCC-15724
• Status: Completed
• Phase: N/A
• Start date: January 23, 2009
• Est. completion date: August 27, 2014

Study information

• Verified date: November 2022
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2124
• Est. completion date: August 27, 2014
• Est. primary completion date: February 18, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Moffitt Cancer Center Clinical Trials website