Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310141
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2006-03-29
Brief Title:
Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Treatment of Nicotine Dependence Among African Americans
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01637 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP30CA016672 |
| R01CA094826 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-01234 | OTHER | None | None |
| CDR0000466339 | REGISTRY | None | None |