Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

Study Overview
=================
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.

Official Title
-----------------
Treatment of Nicotine Dependence Among African Americans

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Smoking cessation intervention
* Other: Counseling intervention
* Drug: Nicotine patch


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care Group<br>Written self-help materials, counseling, and 6-week nicotine patch supply | Other: Counseling intervention<br>* In-person counseling (5 sessions)<br>Drug: Nicotine patch<br>* 6-week supply of the nicotine patch<br>|
| Active Comparator: Computer Treatment Group (CDT)<br>Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment | Behavioral: Smoking cessation intervention<br>* 6 weeks of computer delivered treatment for quitting smoking<br>Other: Counseling intervention<br>* In-person counseling (5 sessions)<br>Drug: Nicotine patch<br>* 6-week supply of the nicotine patch<br>|
| Experimental: CDT Pilot<br>Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment | Behavioral: Smoking cessation intervention<br>* 6 weeks of computer delivered treatment for quitting smoking<br>Other: Counseling intervention<br>* In-person counseling (5 sessions)<br>Drug: Nicotine patch<br>* 6-week supply of the nicotine patch<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer, small cell lung cancer