Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources
NCT ID: NCT01342523
Last Updated: 2015-10-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
1034 participants
INTERVENTIONAL
2011-10-31
2013-10-31
Brief Summary
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Detailed Description
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The primary goal of this research is to obtain experimental data on the effectiveness of the major eHealth and communication smoking cessation interventions (smokefree.gov, women smokefree.gov, and NCI's Quitline counseling services). The primary bases for comparison would be quit attempts and cessation success, and each intervention would be compared with a control condition not receiving the intervention. In addition to the targeted interventions, participants may also be assigned to several different comparison interventions: i.e., email prompts, mailings/brochures, and OTC nicotine medication. The resulting data would allow us to determine effect sizes for each type of intervention relative to a control condition, which would allow us to determine the relative effectiveness of each intervention: i.e., how well the interventions stack-up against one another in terms of effect sizes.
Secondary goals of this research are to:
1. . Determine how much the participants use the interventions;
2. . Determine the mechanisms of benefit (perform meditational analyses);
3. . Compare benefits for important smoker populations;
4. . Determine whether any of the interventions produce subtractive or synergistic effects; and
5. . Obtain basic health economic estimates such as cost/quitter.
The project will also include a substudy directed toward pregnant women and women who are interested in participating but are unwilling to agree to utilize approved contraceptive methods for the duration of the study. This substudy will utilize all of the treatment conditions except the medication condition, since medication is not recommended for women who are pregnant in the US. Department of Health and Human Services treatment guideline for tobacco dependence
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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CIS/no loz/no email/full website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
No CIS/loz/emails/full website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
No CIS/loz/emails/lite website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
No CIS/loz/no emails/full website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
no CIS/no loz/emails/full website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
No CIS/No loz/No Email/Lite Website/Brief Booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, No nicotine lozenge, No motivational emails, lite website, brief mailed booklet
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/No loz/No email/Lite Website/Brief booklet
This arm of the project will address the following question:
Does the following treatment provide efficacy relative to others:
CIS calls, no NRT lozenge, no motivational email, Lite website, Brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
no CIS/Loz/No email/lite website/brief booklet
This arm of the project will address the following question:
Does this combination of services achieve effectiveness compared to others:
No CIS phone counseling, NRT lozenge, no motivational email, lite website, brief mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
No CIS/no loz/email/lite website/brief booklet
This arm of the project will address the following question:
Does this combination of services lead to greater abstinence:
No CIS counseling calls, no NRT lozenge, motivational emails, lite website, brief mailed booklet.
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
No CIS/No loz/No email/Full website/Brief booklet
This arm of the project will address the following question:
Does this combination of services lead to greater abstinence?
No CIS counseling, no NRT lozenge, no motivational email, full website, brief mailed booklet
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
No CIS/No loz/No email/lite website/full booklet
This arm seeks to answer the question:
Does this combination of services achieve efficacy compared to others:
No CIS counseling, no NRT lozenge, no motivational email, lite website, full mailed booklet
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
CIS/Loz/No email/Lite website/Brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, No motivational emails, lite website, brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/No loz/Emails/Lite Website/Brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, No nicotine lozenge, motivational emails, lite website, brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/No loz/no email/full website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, No nicotine lozenge, No motivational emails, full website, brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/No loz/no email/lite website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, No nicotine lozenge, No motivational emails, lite website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
No CIS/Loz/emails/Lite Website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
No CIS/Loz/No emails/lite website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
No CIS/Loz/No emails/full website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
no CIS/no loz/emails/full website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
no CIS/no loz/emails/lite web/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
no CIS/no loz/no email/full website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, no nicotine lozenge, No motivational emails, full website, full mailed booklet
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
CIS/loz/emails/lite website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, motivational emails, lite website, brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/loz/no email/full website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, No motivational emails, full website, brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/loz/no email/lite website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, No motivational emails, lite website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
CIS/no loz/emails/full website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, no nicotine lozenge, motivational emails, full website, brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/no loz/emails/lite website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, no nicotine lozenge, motivational emails, lite website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
CIS/loz/emails/full website/brief booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, motivational emails, full website, brief mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
CIS/loz/emails/lite website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, motivational emails, lite website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
No CIS/loz/emails/full website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
No CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
CIS/no loz/emails/full website/full booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, no nicotine lozenge, motivational emails, full website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
CIS/Loz/no Emails/Full Website/Full Booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, No motivational emails, full website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
CIS/Loz/Emails/Full Website/Full Booklet
This arm of the project will address the following question:
How effective is the following intervention?
CIS calls, nicotine lozenge, motivational emails, full website, full mailed booklet
CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
Interventions
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CIS - telephone cessation quitline counseling
Up to 5 total tobacco cessation counseling calls
Lozenge - nicotine mini-lozenges
2-week starter pack of nicotine mini-lozenges
Emails - Brief smoking prevention messages
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Full website - standard smokefree.gov website content
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Lite website - lite version of smokefree.gov
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Full mailed booklet - NCI's detailed 36-page quit guide
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
brief mailed booklet - smaller version of NCI's booklet
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Timothy B Baker, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Related Links
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Smokefree.gov
Other Identifiers
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2011-0007
Identifier Type: -
Identifier Source: org_study_id
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