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Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources (NCI)

Primary Purpose

Smoking Cessation, Smoking, Nicotine Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CIS - telephone cessation quitline counseling
Lozenge - nicotine mini-lozenges
Emails - Brief smoking prevention messages
Full website - standard smokefree.gov website content
Lite website - lite version of smokefree.gov
Full mailed booklet - NCI's detailed 36-page quit guide
brief mailed booklet - smaller version of NCI's booklet
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking Cessation, Smoking, Nicotine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.)

Sites / Locations

  • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm 26

Arm 27

Arm 28

Arm 29

Arm 30

Arm 31

Arm 32

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

No CIS/No loz/No Email/Lite Website/Brief Booklet

CIS/No loz/No email/Lite Website/Brief booklet

no CIS/Loz/No email/lite website/brief booklet

No CIS/no loz/email/lite website/brief booklet

No CIS/No loz/No email/Full website/Brief booklet

No CIS/No loz/No email/lite website/full booklet

CIS/Loz/No email/Lite website/Brief booklet

CIS/No loz/Emails/Lite Website/Brief booklet

CIS/No loz/no email/full website/brief booklet

CIS/No loz/no email/lite website/full booklet

No CIS/Loz/emails/Lite Website/brief booklet

No CIS/Loz/No emails/lite website/full booklet

No CIS/Loz/No emails/full website/brief booklet

no CIS/no loz/emails/full website/brief booklet

no CIS/no loz/emails/lite web/full booklet

no CIS/no loz/no email/full website/full booklet

CIS/loz/emails/lite website/brief booklet

CIS/loz/no email/full website/brief booklet

CIS/loz/no email/lite website/full booklet

CIS/no loz/emails/full website/brief booklet

CIS/no loz/emails/lite website/full booklet

CIS/no loz/no email/full website/full booklet

No CIS/loz/emails/full website/brief booklet

No CIS/loz/emails/lite website/full booklet

No CIS/loz/no emails/full website/full booklet

no CIS/no loz/emails/full website/full booklet

CIS/loz/emails/full website/brief booklet

CIS/loz/emails/lite website/full booklet

No CIS/loz/emails/full website/full booklet

CIS/no loz/emails/full website/full booklet

CIS/Loz/no Emails/Full Website/Full Booklet

CIS/Loz/Emails/Full Website/Full Booklet

Arm Description

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

7-Day Point-Prevalence Abstinence From Smoking
Abstinence will be defined as 7-day point prevalence.

Secondary Outcome Measures

Smoking Outcomes
Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.
Resource Use/Engagement
We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.
Effectiveness of the Experimental Resources.
We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.
Withdrawal Symptoms
We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.
Perceived Support
We will measure perceived support from both treatment and non-treatment resources.
Treatment Satisfaction
We will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.
Increased Quit Attempts
Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.

Full Information

First Posted
March 8, 2011
Last Updated
October 9, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01342523
Brief Title
Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources
Acronym
NCI
Official Title
Evaluation of NCI Smoking Intervention Resources
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI), Fred Hutchinson Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This 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. 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: . Determine how much the participants use the interventions; . Determine the mechanisms of benefit (perform meditational analyses); . Compare benefits for important smoker populations; . Determine whether any of the interventions produce subtractive or synergistic effects; and . 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Smoking, Nicotine Dependence
Keywords
Smoking Cessation, Smoking, Nicotine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1034 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No CIS/No loz/No Email/Lite Website/Brief Booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/No loz/No email/Lite Website/Brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
no CIS/Loz/No email/lite website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/no loz/email/lite website/brief booklet
Arm Type
Experimental
Arm Description
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.
Arm Title
No CIS/No loz/No email/Full website/Brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/No loz/No email/lite website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/Loz/No email/Lite website/Brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/No loz/Emails/Lite Website/Brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/No loz/no email/full website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/No loz/no email/lite website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/Loz/emails/Lite Website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/Loz/No emails/lite website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/Loz/No emails/full website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
no CIS/no loz/emails/full website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
no CIS/no loz/emails/lite web/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
no CIS/no loz/no email/full website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/loz/emails/lite website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/loz/no email/full website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/loz/no email/lite website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/no loz/emails/full website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/no loz/emails/lite website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/no loz/no email/full website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/loz/emails/full website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/loz/emails/lite website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/loz/no emails/full website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
no CIS/no loz/emails/full website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/loz/emails/full website/brief booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/loz/emails/lite website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
No CIS/loz/emails/full website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/no loz/emails/full website/full booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/Loz/no Emails/Full Website/Full Booklet
Arm Type
Experimental
Arm Description
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
Arm Title
CIS/Loz/Emails/Full Website/Full Booklet
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
CIS - telephone cessation quitline counseling
Intervention Description
Up to 5 total tobacco cessation counseling calls
Intervention Type
Other
Intervention Name(s)
Lozenge - nicotine mini-lozenges
Intervention Description
2-week starter pack of nicotine mini-lozenges
Intervention Type
Other
Intervention Name(s)
Emails - Brief smoking prevention messages
Intervention Description
Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
Intervention Type
Other
Intervention Name(s)
Full website - standard smokefree.gov website content
Intervention Description
Over 50 web pages of resources for quitting smoking, including interactive features and referral links
Intervention Type
Other
Intervention Name(s)
Lite website - lite version of smokefree.gov
Intervention Description
Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
Intervention Type
Other
Intervention Name(s)
Full mailed booklet - NCI's detailed 36-page quit guide
Intervention Description
NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
Intervention Type
Other
Intervention Name(s)
brief mailed booklet - smaller version of NCI's booklet
Intervention Description
12-page booklet developed by the investigators for the research (considered to be placebo intervention)
Primary Outcome Measure Information:
Title
7-Day Point-Prevalence Abstinence From Smoking
Description
Abstinence will be defined as 7-day point prevalence.
Time Frame
Measured after the 3 month follow up assessment
Secondary Outcome Measure Information:
Title
Smoking Outcomes
Description
Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.
Time Frame
Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Title
Resource Use/Engagement
Description
We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.
Time Frame
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.
Title
Effectiveness of the Experimental Resources.
Description
We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.
Time Frame
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.
Title
Withdrawal Symptoms
Description
We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.
Time Frame
Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.
Title
Perceived Support
Description
We will measure perceived support from both treatment and non-treatment resources.
Time Frame
Measured at the1 month, 3 month and 7 month follow up assessments.
Title
Treatment Satisfaction
Description
We will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.
Time Frame
Measured at the 1 month, 3 month and 7 month follow up assessments
Title
Increased Quit Attempts
Description
Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.
Time Frame
Measured at the 1 month, 3 month and 7 month follow up assessments.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: (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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B Baker, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ctri.wisc.edu/
Description
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
URL
http://www.smokefree.gov/
Description
Smokefree.gov

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