Internet and Telephone Counseling for Smoking Cessation
- 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
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
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment
Amanda L. Graham, PhD
Lombardi Cancer Research Center
United States: Food and Drug Administration
|Brown University School of Medicine||Providence, Rhode Island 02905|