Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

Treatment of Nicotine Dependence Among African Americans

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Counseling intervention; Drug: Nicotine patch; Behavioral: Smoking cessation intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 462
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030-4009
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: David W. Wetter, PhD, MS, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Official Website

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2002
• Primary Completion (Actual): August 17, 2006
• Study Completion (Actual): August 30, 2016

Study Registration Dates

• First Submitted: March 29, 2006
• First Submitted That Met QC Criteria: March 29, 2006
• First Posted (Estimate): April 3, 2006

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: ID01-234; P30CA016672 (U.S. NIH Grant/Contract); R01CA094826 (U.S. NIH Grant/Contract); MDA-ID-01234 (Other Identifier: UT MD Anderson Cancer Center); CDR0000466339 (Registry Identifier: NCI PDQ); NCI-2012-01637 (Registry Identifier: NCI CTRP)