NCT00310141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2006

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

4.4 years

First QC Date

March 29, 2006

Last Update Submit

August 18, 2017

Conditions

Lung Cancer

Keywords

non-small cell lung cancersmall cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after treatment

Secondary Outcomes (1)

  • Contemplating smoking by Contemplation Ladder 6 months after treatment

    6 months after treatment

Study Arms (3)

Standard Care Group

ACTIVE COMPARATOR

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

Other: Counseling interventionDrug: Nicotine patch

Computer Treatment Group (CDT)

ACTIVE COMPARATOR

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

Behavioral: Smoking cessation interventionOther: Counseling interventionDrug: Nicotine patch

CDT Pilot

EXPERIMENTAL

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

Behavioral: Smoking cessation interventionOther: Counseling interventionDrug: Nicotine patch

Interventions

Smoking cessation interventionBEHAVIORAL

6 weeks of computer delivered treatment for quitting smoking

CDT PilotComputer Treatment Group (CDT)
Counseling interventionOTHER

In-person counseling (5 sessions)

CDT PilotComputer Treatment Group (CDT)Standard Care Group
Nicotine patchDRUG

6-week supply of the nicotine patch

CDT PilotComputer Treatment Group (CDT)Standard Care Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

CounselingTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesTherapeutics

Study Officials

  • David W. Wetter, PhD, MS

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

April 3, 2006

Study Start

April 8, 2002

Primary Completion

August 17, 2006

Study Completion

August 30, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

US(1)