Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Study Overview
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Brief Summary
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The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.

Detailed Description
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Many Americans engage in the habitual use of smokeless tobacco (ST), and many wish to quit but lack resources. There is a need for innovative, validated, and easily delivered low-cost interventions to facilitate ST cessation in this under-served population of tobacco users. In our current ChewFree study, we have developed a user-friendly, interactive Web-based intervention, and in a randomized trial we have shown this website to be more efficacious than a rigorous control condition that offered Web-based basic textual information on ST cessation. We now seek to extend this proven approach by marrying it with a quitline telephone counseling service that has been used with noteworthy success for smoking abstinence but has not yet been evaluated with ST users. Our 2 x 2 design and large sample size allow us to test both main effects - Web program, phone counseling - as well as explore planned comparisons to examine the value-added contribution of the Web-based intervention to phone counseling, and vice-versa. This project takes advantage of the opportunity to conduct a study of two tobacco cessation interventions that are growing in use. The use of tobacco help lines is now almost ubiquitous, with more than 30 state and national services now being offered. The use of the Internet for health information and behavior change (including tobacco cessation) has been growing in popularity as well. The proposed project would be an extension of both lines of research, evaluating the relative efficacy of our Internet-based program, telephone counseling, and the combination of both. We will use a multifaceted promotional plan to recruit more than 2,000 ST users. The recruitment plan builds on the collaborative marketing efforts of a state tobacco control organization and organized promotion through media mailings, on-line advertising, and direct mailing. Follow-up assessment data will be collected electronically via the Internet supplemented by telephone follow-up. Additional data will be derived from phone counselor notes and measures of website usage.

Official Title
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Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Web + Phone
* Behavioral: Web Only
* Behavioral: Phone Only
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current users of smokeless tobacco products (snuff or chewing tobacco) use of smokeless tobacco products for at least 1 year use of at least one tin or pouch per week interest in quitting all tobacco U.S. resident 18 years of age or older ability to read English willingness to share a phone number, e-mail, and mailing address use of personal Internet e-mail account at least once per week informed consent Exclusion criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web + Phone<br>Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling | Behavioral: Web + Phone<br>* Web + Phone<br>* Other names: helpline;|
| Experimental: Web Only<br>Highly interactive tailored Web-based smokeless tobacco cessation program | Behavioral: Web Only<br>* Web Only<br>* Other names: web-assisted intervention;|
| Experimental: Phone Only<br>Phone counseling intervention for smokeless tobacco cessation | Behavioral: Phone Only<br>* Phone Only<br>* Other names: quitline;|
| Experimental: Control<br>Usual care (initial call plus self-help materials) | Behavioral: Usual Care<br>* Usual Care<br>* Other names: quitline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged abstinence from all tobacco |  | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence for smokeless tobacco use |  | 3 months and 6 months | 
| 7-day point prevalence for all tobacco use |  | 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smokeless tobacco, Chewing Tobacco, Internet, Adolescent