Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282009
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2006-01-24
Brief Title:
Internet and Telephone Counseling for Smoking Cessation
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Internet and Telephone Counseling for Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2014-08
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 Computer-assisted stop-smoking plans and telephone counseling may help people stop smoking It is not yet known which computer-based smoking cessation program is more effective with or without telephone counseling in helping smokers quit smoking
PURPOSE This randomized clinical trial is studying two different computer-based smoking cessation programs to compare how well they work with or without telephone counseling in helping smokers quit smoking
PURPOSE This randomized clinical trial is studying two different computer-based smoking cessation programs to compare how well they work with or without telephone counseling in helping smokers quit smoking
Detailed Description:
OBJECTIVES
Compare the efficacy of premium internet intervention vs premium internet with telephone intervention vs basic internet intervention as determined by 7-day point prevalence abstinence at 12 months in adult smokers
Compare the cost-effectiveness of these interventions in promoting smoking cessation
Determine the effects of internet-based interventions on measured use of the intervention frequency and duration of use utilization of behavioral coping expert advices and e-mail in these patients
Determine the effects of internet-based interventions on variables important for behavior change including mediators eg self-efficacy use of internet social support and moderators eg gender baseline motivation of outcomes in these patients
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to gender and baseline motivation level Patients are randomized to 1 of 3 intervention arms
Arm I basic internet program Patients are directed to a website of existing QuitNet smoking cessation materials These materials are not tailored and have no interactive features
Arm II premium internet program Patients receive free 6-month access to the QuitNet website including interactive and individualized intervention features
Arm III premium internet program plus telephone counseling Patients receive free access to the QuitNet website as in arm II Patients also receive up to 5 telephone counseling sessions scheduled at their convenience
All patients are assessed at baseline and then at 3 6 12 and 18 months
PROJECTED ACCRUAL A total of 2205 patients will be accrued for this study
Compare the efficacy of premium internet intervention vs premium internet with telephone intervention vs basic internet intervention as determined by 7-day point prevalence abstinence at 12 months in adult smokers
Compare the cost-effectiveness of these interventions in promoting smoking cessation
Determine the effects of internet-based interventions on measured use of the intervention frequency and duration of use utilization of behavioral coping expert advices and e-mail in these patients
Determine the effects of internet-based interventions on variables important for behavior change including mediators eg self-efficacy use of internet social support and moderators eg gender baseline motivation of outcomes in these patients
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to gender and baseline motivation level Patients are randomized to 1 of 3 intervention arms
Arm I basic internet program Patients are directed to a website of existing QuitNet smoking cessation materials These materials are not tailored and have no interactive features
Arm II premium internet program Patients receive free 6-month access to the QuitNet website including interactive and individualized intervention features
Arm III premium internet program plus telephone counseling Patients receive free access to the QuitNet website as in arm II Patients also receive up to 5 telephone counseling sessions scheduled at their convenience
All patients are assessed at baseline and then at 3 6 12 and 18 months
PROJECTED ACCRUAL A total of 2205 patients 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 |
|---|---|---|---|
| R01CA104836 | NIH | None | httpsreporternihgovquickSearchR01CA104836 |