Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00310141
First received: March 29, 2006
Last updated: June 14, 2013
Last verified: June 2013
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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 2015 (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:
- African American
- Age 21 to 65 years
- Current Smoker (history of at least 5 cigarettes/day for the last year)
- Motivated to quit within the next 14 days
- Participants must provide a viable home address and functioning home telephone number
- Can speak, read, write in English at a sixth-grade literacy level
- Provide viable collateral contact information
- Register "8" or more on a carbon monoxide breath test
Exclusion Criteria:
- Contraindication for nicotine patch use
- Active substance dependence (exclusive of nicotine dependence)
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)
- Use of bupropion or nicotine products other than nicotine patches supplied by the study
- Pregnancy or lactation
- Any active illness that precludes full participation in the study protocol
- Another household member enrolled in the study
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, 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 |
| Study First Received: | March 29, 2006 |
| Last Updated: | June 14, 2013 |
| 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 June 18, 2013