NCT00282009

Internet and Telephone Counseling for Smoking Cessation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,205 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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: * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BEHAVIORAL	Basic Internet	Basic Internet control intervention
BEHAVIORAL	Enhanced Internet	enhanced Internet cessation intervention
BEHAVIORAL	Enhanced Internet + phone	enhanced Internet plus proactive telephone counseling

Timeline

• Start date: 2004-08-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2006-01-25
• Last updated: 2016-02-10

Locations

1 site across 1 country: United States