Internet and Telephone Counseling for Smoking Cessation
|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 ]
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|