Internet and Telephone Counseling for Smoking Cessation
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 24, 2006 | ||||
| Last Updated Date | April 3, 2012 | ||||
| Start Date ICMJE | August 2004 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00282009 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Internet and Telephone Counseling for Smoking Cessation | ||||
| Official Title ICMJE | Internet and Telephone Counseling for Smoking Cessation | ||||
| 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. |
||||
| Detailed Description | OBJECTIVES:
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.
All patients are assessed at baseline and then at 3, 6, 12, and 18 months. PROJECTED ACCRUAL: A total of 2,205 patients will be accrued for this study. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
||||
| Condition ICMJE | Unspecified Adult Solid Tumor, Protocol Specific | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 2205 | ||||
| Estimated Completion Date | December 2012 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00282009 | ||||
| Other Study ID Numbers ICMJE | CDR0000465179, R01CA104836, GUMC-5-R01CA104836, RWMC-5-R01CA104836 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Georgetown University | ||||
| Study Sponsor ICMJE | Georgetown University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Georgetown University | ||||
| Verification Date | April 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||