Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00310141
First received: March 29, 2006
Last updated: June 16, 2014
Last verified: June 2014

March 29, 2006
June 16, 2014
April 2002
April 2016   (final data collection date for primary outcome measure)
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00310141 on ClinicalTrials.gov Archive Site
Contemplating smoking by Contemplation Ladder 6 months after treatment [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Lung Cancer
  • Behavioral: Smoking cessation intervention
    6 weeks of computer delivered treatment for quitting smoking
  • Other: Counseling intervention
    In-person counseling (5 sessions)
  • Drug: Nicotine patch
    6-week supply of the nicotine patch
  • Active Comparator: Standard Care Group
    Written self-help materials, counseling, and 6-week nicotine patch supply
    Interventions:
    • Other: Counseling intervention
    • Drug: 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
    Interventions:
    • Behavioral: Smoking cessation intervention
    • Other: Counseling intervention
    • Drug: Nicotine patch
  • Experimental: CDT Pilot
    Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
    Interventions:
    • Behavioral: Smoking cessation intervention
    • Other: Counseling intervention
    • Drug: Nicotine patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
Not Provided
April 2016   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00310141
ID01-234, R01CA094826, P30CA016672, MDA-ID-01234, CDR0000466339, NCI-2012-01637
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: David W. Wetter, PhD, MS M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP