Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments smoking cessation intervention, counseling intervention, nicotine patch
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date April 2002
End date April 2018
Trial size 500 participants
Trial identifier NCT00310141, CDR0000466339, ID01-234, MDA-ID-01234, NCI-2012-01637, P30CA016672, R01CA094826

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Written self-help materials, counseling, and 6-week nicotine patch supply
counseling intervention
In-person counseling (5 sessions)
nicotine patch
6-week supply of the nicotine patch
(Active Comparator)
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
smoking cessation intervention
6 weeks of computer delivered treatment for quitting smoking
counseling intervention
In-person counseling (5 sessions)
nicotine patch
6-week supply of the nicotine patch
(Experimental)
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
smoking cessation intervention
6 weeks of computer delivered treatment for quitting smoking
counseling intervention
In-person counseling (5 sessions)
nicotine patch
6-week supply of the nicotine patch

Primary Outcomes

Measure
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
time frame: 6 months after treatment

Secondary Outcomes

Measure
Contemplating smoking by Contemplation Ladder 6 months after treatment
time frame: 6 months after treatment

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

Inclusion Criteria: 1. African American 2. Age 21 to 65 years 3. Current Smoker (history of at least 5 cigarettes/day for the last year) 4. Motivated to quit within the next 14 days 5. Participants must provide a viable home address and functioning home telephone number 6. Can speak, read, write in English at a sixth-grade literacy level 7. Provide viable collateral contact information 8. Register "8" or more on a carbon monoxide breath test Exclusion Criteria: 1. Contraindication for nicotine patch use 2. Active substance dependence (exclusive of nicotine dependence) 3. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless) 4. Use of bupropion or nicotine products other than nicotine patches supplied by the study 5. Pregnancy or lactation 6. Any active illness that precludes full participation in the study protocol 7. Another household member enrolled in the study

Additional Information

Official title Treatment of Nicotine Dependence Among African Americans
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.