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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 500
Study Start Date: April 2002
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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, MS M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00310141     History of Changes
Other Study ID Numbers: ID01-234, R01CA094826, P30CA016672, MDA-ID-01234, CDR0000466339, NCI-2012-01637
Study First Received: March 29, 2006
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lung Neoplasms
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014