Lung Cancer Clinical Trial

Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

Summary

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.

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

African American
Age 21 to 65 years
Current Smoker (history of at least 5 cigarettes/day for the last year)
Motivated to quit within the next 14 days
Participants must provide a viable home address and functioning home telephone number
Can speak, read, write in English at a sixth-grade literacy level
Provide viable collateral contact information
Register "8" or more on a carbon monoxide breath test

Exclusion Criteria:

Contraindication for nicotine patch use
Active substance dependence (exclusive of nicotine dependence)
Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)
Use of bupropion or nicotine products other than nicotine patches supplied by the study
Pregnancy or lactation
Any active illness that precludes full participation in the study protocol
Another household member enrolled in the study

Study is for people with:

Lung Cancer

Estimated Enrollment:

462

Study ID:

NCT00310141

Recruitment Status:

Completed

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

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Study is for people with:

Lung Cancer

Estimated Enrollment:

462

Study ID:

NCT00310141

Recruitment Status:

Completed

Sponsor:


M.D. Anderson Cancer Center

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