Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Web + Phone
Web Only
Phone Only
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smokeless tobacco, Chewing Tobacco, Internet, Adolescent
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
Sites / Locations
- University of California, San Diego
- Oregon Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Web + Phone
Web Only
Phone Only
Control
Arm Description
Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling
Highly interactive tailored Web-based smokeless tobacco cessation program
Phone counseling intervention for smokeless tobacco cessation
Usual care (initial call plus self-help materials)
Outcomes
Primary Outcome Measures
Prolonged abstinence from all tobacco
Secondary Outcome Measures
7-day point prevalence for smokeless tobacco use
7-day point prevalence for all tobacco use
Full Information
NCT ID
NCT00820495
First Posted
January 8, 2009
Last Updated
August 2, 2013
Sponsor
Oregon Research Institute
Collaborators
National Cancer Institute (NCI), University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00820495
Brief Title
Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Official Title
Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Cancer Institute (NCI), University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smokeless tobacco, Chewing Tobacco, Internet, Adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1683 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web + Phone
Arm Type
Experimental
Arm Description
Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling
Arm Title
Web Only
Arm Type
Experimental
Arm Description
Highly interactive tailored Web-based smokeless tobacco cessation program
Arm Title
Phone Only
Arm Type
Experimental
Arm Description
Phone counseling intervention for smokeless tobacco cessation
Arm Title
Control
Arm Type
Experimental
Arm Description
Usual care (initial call plus self-help materials)
Intervention Type
Behavioral
Intervention Name(s)
Web + Phone
Other Intervention Name(s)
web-assisted intervention, quitline, helpline
Intervention Description
Web + Phone
Intervention Type
Behavioral
Intervention Name(s)
Web Only
Other Intervention Name(s)
web-assisted intervention
Intervention Description
Web Only
Intervention Type
Behavioral
Intervention Name(s)
Phone Only
Other Intervention Name(s)
helpline, quitline
Intervention Description
Phone Only
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Other Intervention Name(s)
helpline, quitline
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
Prolonged abstinence from all tobacco
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
7-day point prevalence for smokeless tobacco use
Time Frame
3 months and 6 months
Title
7-day point prevalence for all tobacco use
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert H. Severson, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25914872
Citation
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.
Results Reference
derived
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Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
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