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Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking cessation intervention
Counseling intervention
Nicotine patch
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer, small cell lung cancer

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Standard Care Group

Computer Treatment Group (CDT)

CDT Pilot

Arm Description

Written self-help materials, counseling, and 6-week nicotine patch supply

Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment

Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment

Outcomes

Primary Outcome Measures

Smoking status by SRNT Smoking Status Questionnaire 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
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).

Full Information

First Posted
March 29, 2006
Last Updated
August 18, 2017
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00310141
Brief Title
Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
Official Title
Treatment of Nicotine Dependence Among African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 8, 2002 (Actual)
Primary Completion Date
August 17, 2006 (Actual)
Study Completion Date
August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
non-small cell lung cancer, small cell lung cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
462 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care Group
Arm Type
Active Comparator
Arm Description
Written self-help materials, counseling, and 6-week nicotine patch supply
Arm Title
Computer Treatment Group (CDT)
Arm Type
Active Comparator
Arm Description
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
Arm Title
CDT Pilot
Arm Type
Experimental
Arm Description
Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation intervention
Intervention Description
6 weeks of computer delivered treatment for quitting smoking
Intervention Type
Other
Intervention Name(s)
Counseling intervention
Intervention Description
In-person counseling (5 sessions)
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Intervention Description
6-week supply of the nicotine patch
Primary Outcome Measure Information:
Title
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
Description
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.
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Contemplating smoking by Contemplation Ladder 6 months after treatment
Description
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).
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W. Wetter, PhD, MS
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Official Website

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Computer-Assisted Counseling in Helping African American Smokers Stop Smoking

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