RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking. PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.
OBJECTIVES: * Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers. * Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence. OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms. * Arm I (standard care \[SC\]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date. * Arm II (computer-delivered treatment \[CDT\]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date. All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date. After completion of study intervention, participants are followed at approximately 6 months. PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
462
6 weeks of computer delivered treatment for quitting smoking
In-person counseling (5 sessions)
6-week supply of the nicotine patch
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
Abstinence measures are collected at four post cessation follow-up visits. Point prevalence serving as the primary outcome measure. Primary outcome analyses will use data from all of the follow-up visits. SRNT Abstinence Status Questionnaire (Hughes et al., 2003) surveys the tobacco use by the participant and persons within the participant's household and social surroundings. The questionnaire also collects data on the use of other tobacco products and nicotine replacement medications. The pre- and post-quit versions of this questionnaire have been adapted to specific timepoints corresponding to participant visits.
Time frame: 6 months after treatment
Contemplating smoking by Contemplation Ladder 6 months after treatment
The Contemplation Ladder (Biener \& Abrams, 1991) assesses readiness to quit smoking and ranges from 0-10 with 0 being "no thought of quitting" and 10 being "taking action to quit" (e.g., cutting down, enrolling in a program).
Time frame: 6 months after treatment
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