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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
  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 Behavioral: Smoking cessation intervention Other: Counseling intervention Drug: Nicotine patch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment of Nicotine Dependence Among African Americans

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 462
Actual Study Start Date: April 8, 2002
Study Completion Date: August 30, 2016
Primary Completion Date: August 17, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: CDT Pilot
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310141


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: David W. Wetter, PhD, MS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00310141     History of Changes
Other Study ID Numbers: 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 )
First Submitted: March 29, 2006
First Posted: April 3, 2006
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by M.D. Anderson Cancer Center:
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action