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Extended Self-Help for Smoking Cessation

Phase 2
18 Years
Open (Enrolling)
Smoking Cessation

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Trial Information

Extended Self-Help for Smoking Cessation

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.


- 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:

- we will limit the number of participants from the same street address to 1

- we not allow more than 2 referrals per participant

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

7-Day Point-Prevalence Abstinence at Each Follow-up Point

Outcome Description:

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.

Outcome Time Frame:

30 months per participant

Safety Issue:


Principal Investigator

Thomas Brandon, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

December 2014

Related Keywords:

  • Smoking Cessation
  • Forever Free
  • Smoking



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612