Internet and Telephone Counseling for Smoking Cessation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Internet and Telephone Counseling for Smoking Cessation

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: Basic Internet
* Behavioral: Enhanced Internet
* Behavioral: Enhanced Internet + phone


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Smokes at least 5 cigarettes a day No prior use of QuitNet website Must have access to the internet and a telephone at home or work PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Basic Internet<br>Basic Internet | Behavioral: Basic Internet<br>* Basic Internet control intervention<br>|
| Experimental: Enhanced Internet<br>Enhanced Internet | Behavioral: Enhanced Internet<br>* enhanced Internet cessation intervention<br>|
| Experimental: Enhanced Internet plus Phone<br>Enhanced Internet + proactive telephone counseling | Behavioral: Enhanced Internet + phone<br>* enhanced Internet plus proactive telephone counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific