Clinical trial NCT00310141: Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
Official title: Treatment of Nicotine Dependence Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
small cell lung cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-04-03
Enrollment: 462
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Contemplating smoking by Contemplation Ladder 6 months after treatment
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David W. Wetter, PhD, MS
role: STUDY_CHAIR
References: