Extended Self-Help for Smoking Cessation
1 other identifier
interventional
2,124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 23, 2009
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2014
CompletedNovember 3, 2022
November 1, 2022
5.1 years
May 10, 2011
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Usual Care (UC)
ACTIVE COMPARATORThis condition will comprise a single, high quality booklet that is currently in dissemination: NCI's Clearing the Air (NCI, 2003).
Standard Repeated Mailings (Stand-RM)
ACTIVE COMPARATORStand-RM will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies.
Intensive Repeated Mailings (Inten-RM)
ACTIVE COMPARATORInten-RM will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts.
Interventions
Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- number of participants from the same street address limited to 1
- no more than 2 referrals per participant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related Publications (1)
Brandon TH, Simmons VN, Sutton SK, Unrod M, Harrell PT, Meade CD, Craig BM, Lee JH, Meltzer LR. Extended Self-Help for Smoking Cessation: A Randomized Controlled Trial. Am J Prev Med. 2016 Jul;51(1):54-62. doi: 10.1016/j.amepre.2015.12.016. Epub 2016 Feb 8.
PMID: 26868284DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Brandon, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 11, 2011
Study Start
January 23, 2009
Primary Completion
February 18, 2014
Study Completion
August 27, 2014
Last Updated
November 3, 2022
Record last verified: 2022-11