Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

NCT ID: NCT00820495

Last Updated: 2013-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1683 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-05-31

Brief Summary

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

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Web + Phone

Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling

Group Type: EXPERIMENTAL

Web + Phone

Intervention Type: BEHAVIORAL

Web + Phone

Web Only

Highly interactive tailored Web-based smokeless tobacco cessation program

Group Type: EXPERIMENTAL

Web Only

Intervention Type: BEHAVIORAL

Web Only

Phone Only

Phone counseling intervention for smokeless tobacco cessation

Group Type: EXPERIMENTAL

Phone Only

Intervention Type: BEHAVIORAL

Phone Only

Control

Usual care (initial call plus self-help materials)

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: BEHAVIORAL

Usual Care

Interventions

Web + Phone

Web + Phone

Intervention Type: BEHAVIORAL

Web Only

Web Only

Intervention Type: BEHAVIORAL

Phone Only

Phone Only

Intervention Type: BEHAVIORAL

Usual Care

Usual Care

Intervention Type: BEHAVIORAL

Other Intervention Names

web-assisted intervention; quitline; helpline; web-assisted intervention; helpline; quitline; helpline; quitline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

Oregon Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert H. Severson, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

University of California, San Diego

San Diego, California, United States

Oregon Research Institute

Eugene, Oregon, United States

Countries

United States

References

Danaher BG, Severson HH, Zhu SH, Andrews JA, Cummins SE, Lichtenstein E, Tedeschi GJ, Hudkins C, Widdop C, Crowley R, Seeley JR. Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation. Internet Interv. 2015 May 1;2(2):143-151. doi: 10.1016/j.invent.2015.02.005.

Reference Type: DERIVED

PMID: 25914872 (View on PubMed)

Other Identifiers

R01CA084225

Identifier Type: NIH

Identifier Source: secondary_id

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R01CA084225

Identifier Type: NIH

Identifier Source: org_study_id

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