Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources
NCI
Evaluation of NCI Smoking Intervention Resources
1 other identifier
interventional
1,034
1 country
1
Brief Summary
This is an evaluative study of three National Cancer Institute (NCI) smoking cessation resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS counseling phone calls. The following are the identified critical questions: (1). How effective is each of the tobacco interventions (websites \[smokefree.gov \& women smokefree.gov\], NCI's Cessation Quitline counseling services operated by the Cancer Information Service (CIS) (2). How do they compare with alternative intervention strategies? (3). Which types of interventions appear to work best together (due to additive or interactive effects)? (4). How do these interventions work? (5). How much are these interventions used, and what are their relative use rates? (6). Are there important differences in effectiveness or use rates as a function of gender, SES, or other important person factors? We believe that the research study will address all of these questions, as well as some less central ones.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
March 5, 2014
CompletedOctober 14, 2015
October 1, 2015
7 months
March 8, 2011
December 12, 2013
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-Day Point-Prevalence Abstinence From Smoking
Abstinence will be defined as 7-day point prevalence.
Measured after the 3 month follow up assessment
Secondary Outcomes (7)
Smoking Outcomes
Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Resource Use/Engagement
Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.
Effectiveness of the Experimental Resources.
Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.
Withdrawal Symptoms
Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Perceived Support
Measured at the1 month, 3 month and 7 month follow up assessments.
- +2 more secondary outcomes
Study Arms (32)
No CIS/No loz/No Email/Lite Website/Brief Booklet
EXPERIMENTALThis 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
CIS/No loz/No email/Lite Website/Brief booklet
EXPERIMENTALThis 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
no CIS/Loz/No email/lite website/brief booklet
EXPERIMENTALThis 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
No CIS/no loz/email/lite website/brief booklet
EXPERIMENTALThis 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.
No CIS/No loz/No email/Full website/Brief booklet
EXPERIMENTALThis 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
No CIS/No loz/No email/lite website/full booklet
EXPERIMENTALThis 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
CIS/Loz/No email/Lite website/Brief booklet
EXPERIMENTALThis 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/No loz/Emails/Lite Website/Brief booklet
EXPERIMENTALThis 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/No loz/no email/full website/brief booklet
EXPERIMENTALThis 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/No loz/no email/lite website/full booklet
EXPERIMENTALThis 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
No CIS/Loz/emails/Lite Website/brief booklet
EXPERIMENTALThis 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
No CIS/Loz/No emails/lite website/full booklet
EXPERIMENTALThis 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
No CIS/Loz/No emails/full website/brief booklet
EXPERIMENTALThis 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
no CIS/no loz/emails/full website/brief booklet
EXPERIMENTALThis 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
no CIS/no loz/emails/lite web/full booklet
EXPERIMENTALThis 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
no CIS/no loz/no email/full website/full booklet
EXPERIMENTALThis 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
CIS/loz/emails/lite website/brief booklet
EXPERIMENTALThis 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/loz/no email/full website/brief booklet
EXPERIMENTALThis 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/loz/no email/lite website/full booklet
EXPERIMENTALThis 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/no loz/emails/full website/brief booklet
EXPERIMENTALThis 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/no loz/emails/lite website/full booklet
EXPERIMENTALThis 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/no loz/no email/full website/full booklet
EXPERIMENTALThis 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
No CIS/loz/emails/full website/brief booklet
EXPERIMENTALThis 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
No CIS/loz/emails/lite website/full booklet
EXPERIMENTALThis 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
No CIS/loz/no emails/full website/full booklet
EXPERIMENTALThis 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
no CIS/no loz/emails/full website/full booklet
EXPERIMENTALThis 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
CIS/loz/emails/full website/brief booklet
EXPERIMENTALThis 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/loz/emails/lite website/full booklet
EXPERIMENTALThis 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
No CIS/loz/emails/full website/full booklet
EXPERIMENTALThis 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
CIS/no loz/emails/full website/full booklet
EXPERIMENTALThis 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/Loz/no Emails/Full Website/Full Booklet
EXPERIMENTALThis 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/Loz/Emails/Full Website/Full Booklet
EXPERIMENTALThis 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
Interventions
Up to 5 total tobacco cessation counseling calls
2-week starter pack of nicotine mini-lozenges
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
Eligibility Criteria
You may qualify if:
- (1). Interest in quitting smoking within the next 30 days, but not already actively engaged in quitting (e.g., subject should not be currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). The person has a phone and has home internet access; (3). The person has an email address that can be used to send assessments, and deliver email prompts; (4). The person expresses willingness to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes ≥ 5 cpd; (7). The person is ≥ 18 years;(8). The person accesses the internet with no more than 3 computers/devices (including devices such as iPads and smartphones); and (9). No other members of the person's household are participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.) Subjects will not have to express an interest in using NRT. They may be sent NRT depending upon experimental assignment, but a commitment to use medication is not a requirement of participation. Also, pregnant smokers, or those who believe they may become pregnant, can participate, but they will be randomly assigned to only the non-medication treatments and participate only in the substudy. \[They will not be included in the regular data analyses, and power will be too small to permit meaningful inferential tests. However, effect sizes in this small group of smokers will be determined for comparison with the effect sizes obtained in the main study.\] Due to limitations in the volume of new calls that can be handled in the phone counseling component, recruitment will not exceed 300 per month. When monthly recruitment goal has been met, the recruitment invitation will be turned off until the following month. At the point where it is necessary to achieve the desired (50/50) gender balance, the invitation to participate in the study will be restricted by sex until full enrollment is achieved.
You may not qualify if:
- (1). If the person has no interest in quitting smoking within the next 30 days or if the person is actively engaged in quitting (e.g., subject is currently participating in other cessation counseling or taking cessation medication treatment for the purpose of a quit attempt); (2). Person does not have a phone or home internet access; (3). The person does not have an email address that can be used to send assessments, and deliver email prompts; (4). The person is not willing to provide assessment information and have his/her computer use of the assigned website tracked; (5). There are contraindications to over the counter nicotine replacement therapy (NRT) use (e.g., pregnancy); (6). The person smokes \< 5 cpd; (7). The person is \<18 years;(8). The person accesses the internet with more than 4 computers (including devices such as iPads and smartphones); and (9). One or more members of the person's household are already participating in the NCI website evaluation. (The age restriction is due to the possible assignment to medication, which is not recommended for adolescents.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Cancer Institute (NCI)collaborator
- Fred Hutchinson Cancer Centercollaborator
Study Sites (1)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stevens Smith, PhD
- Organization
- University of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy B Baker, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2011
First Posted
April 27, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2012
Study Completion
October 1, 2013
Last Updated
October 14, 2015
Results First Posted
March 5, 2014
Record last verified: 2015-10