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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA094826 | U.S. NIH Grant/Contract | View source | |
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-01234 | Other Identifier | UT MD Anderson Cancer Center | |
| CDR0000466339 | Registry Identifier | NCI PDQ | |
| NCI-2012-01637 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Group | Active Comparator | Written self-help materials, counseling, and 6-week nicotine patch supply |
|
| Computer Treatment Group (CDT) | Active Comparator | Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment |
|
| CDT Pilot | Experimental | Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation intervention | Behavioral | 6 weeks of computer delivered treatment for quitting smoking |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W. Wetter, PhD, MS | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Counseling intervention | Other | In-person counseling (5 sessions) |
|
| Nicotine patch | Drug | 6-week supply of the nicotine patch |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D005159 | Health Care Facilities Workforce and Services |
| D013812 | Therapeutics |