Internet and Telephone Counseling for Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT00282009|
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : February 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Behavioral: Basic Internet Behavioral: Enhanced Internet Behavioral: Enhanced Internet + phone||Not Applicable|
- 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 (e.g., self-efficacy, use of internet social support) and moderators (e.g., 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 2,205 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2205 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Internet and Telephone Counseling for Smoking Cessation|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Basic Internet
Behavioral: Basic Internet
Basic Internet control intervention
Experimental: Enhanced Internet
Behavioral: Enhanced Internet
enhanced Internet cessation intervention
Experimental: Enhanced Internet plus Phone
Enhanced Internet + proactive telephone counseling
Behavioral: Enhanced Internet + phone
enhanced Internet plus proactive telephone counseling
- Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282009
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Amanda L. Graham, PhD||Lombardi Comprehensive Cancer Center|