Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-08

Study Completion Date

2016-08-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Care Group

Written self-help materials, counseling, and 6-week nicotine patch supply

Group Type ACTIVE_COMPARATOR

Counseling intervention

Intervention Type OTHER

In-person counseling (5 sessions)

Nicotine patch

Intervention Type DRUG

6-week supply of the nicotine patch

Computer Treatment Group (CDT)

Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment

Group Type ACTIVE_COMPARATOR

Smoking cessation intervention

Intervention Type BEHAVIORAL

6 weeks of computer delivered treatment for quitting smoking

Counseling intervention

Intervention Type OTHER

In-person counseling (5 sessions)

Nicotine patch

Intervention Type DRUG

6-week supply of the nicotine patch

CDT Pilot

Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment

Group Type EXPERIMENTAL

Smoking cessation intervention

Intervention Type BEHAVIORAL

6 weeks of computer delivered treatment for quitting smoking

Counseling intervention

Intervention Type OTHER

In-person counseling (5 sessions)

Nicotine patch

Intervention Type DRUG

6-week supply of the nicotine patch

Interventions

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Smoking cessation intervention

6 weeks of computer delivered treatment for quitting smoking

Intervention Type BEHAVIORAL

Counseling intervention

In-person counseling (5 sessions)

Intervention Type OTHER

Nicotine patch

6-week supply of the nicotine patch

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No