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Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00310141
  Purpose

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.


Condition Intervention
Lung Cancer
Procedure: counseling
Procedure: smoking cessation intervention

MedlinePlus related topics: Cancer Lung Cancer Smoking
Drug Information available for: Nicotine polacrilex Nicotine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized
Official Title: Treatment of Nicotine Dependence Among African Americans

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Contemplating smoking by Contemplation Ladder 6 months after treatment [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • African American
  • Current smoker

    • Smokes ≥ 5 cigarettes a day for the past year
    • Motivated to quit smoking within the next 14 days
  • Registers ≥ 8 on carbon monoxide breath test

PATIENT CHARACTERISTICS:

  • Viable home address and functioning home telephone number
  • Provides viable collateral contact information
  • Able to read, speak, and write in English at a sixth-grade literacy level
  • No contraindication for nicotine patch use
  • No active substance dependence (except for nicotine dependence)
  • No regular use of tobacco products other than cigarettes (e.g., cigars, pipes, smokeless)
  • Not pregnant or nursing
  • Fertile participants must use effective contraception
  • No active illness that precludes full participation in the study
  • Only member of a household in this study

PRIOR CONCURRENT THERAPY:

  • No other concurrent bupropion hydrochloride or nicotine products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310141

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: David W. Wetter, PhD M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000466339, MDA-ID-01234
Study First Received: March 29, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00310141  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
small cell lung cancer

Study placed in the following topic categories:
Nicotine polacrilex
Thoracic Neoplasms
Carcinoma, Small Cell
Smoking
Non-small cell lung cancer
Respiratory Tract Diseases
Nicotine
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009