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Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310141
First Posted: April 3, 2006
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
March 29, 2006
April 3, 2006
August 22, 2017
April 8, 2002
August 17, 2006   (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 ]
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.
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 ]
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).
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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
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
462
August 30, 2016
August 17, 2006   (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
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00310141
ID01-234
R01CA094826 ( U.S. NIH Grant/Contract )
P30CA016672 ( 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 )
No
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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
August 2017

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