Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Fred Hutchinson Cancer Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No CIS/No loz/No Email/Lite Website/Brief Booklet | Experimental | 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 |
|
| CIS/No loz/No email/Lite Website/Brief booklet | Experimental | 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 |
|
| no CIS/Loz/No email/lite website/brief booklet | Experimental | 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 |
|
| No CIS/no loz/email/lite website/brief booklet | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIS - telephone cessation quitline counseling | Other | Up to 5 total tobacco cessation counseling calls |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Point-Prevalence Abstinence From Smoking | Abstinence will be defined as 7-day point prevalence. | Measured after the 3 month follow up assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Outcomes | Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date. | Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. |
| Resource Use/Engagement |
Not provided
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.)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy B Baker, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin | 53711 | United States |
Not provided
| Label | URL |
|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | View source |
| Smokefree.gov | View source |
Not provided
Prior to randomization, potential participants were asked to make a "confirmation" call to an automated answering system to confirm willingness to perform study procedures. The call was intended to increase the likelihood that individuals would take treatment and follow-up calls. Randomization occurred immediately after the confirmation call.
The recruitment period ran from November 28, 2011 through March 26, 2013. All study participants were recruited through the portal to the smokefree.gov website.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No CIS/No Loz/No Email/Lite Website/Brief Booklet | |
| FG001 | CIS/No Loz/No Email/Lite Website/Brief Booklet | |
| FG002 | no CIS/Loz/No Email/Lite Website/Brief Booklet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| No CIS/No loz/No email/Full website/Brief booklet | Experimental | 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 |
|
| No CIS/No loz/No email/lite website/full booklet | Experimental | 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 |
|
| CIS/Loz/No email/Lite website/Brief booklet | Experimental | 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/No loz/Emails/Lite Website/Brief booklet | Experimental | 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/No loz/no email/full website/brief booklet | Experimental | 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/No loz/no email/lite website/full booklet | Experimental | 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 |
|
| No CIS/Loz/emails/Lite Website/brief booklet | Experimental | 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 |
|
| No CIS/Loz/No emails/lite website/full booklet | Experimental | 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 |
|
| No CIS/Loz/No emails/full website/brief booklet | Experimental | 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 |
|
| no CIS/no loz/emails/full website/brief booklet | Experimental | 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 |
|
| no CIS/no loz/emails/lite web/full booklet | Experimental | 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 |
|
| no CIS/no loz/no email/full website/full booklet | Experimental | 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 |
|
| CIS/loz/emails/lite website/brief booklet | Experimental | 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/loz/no email/full website/brief booklet | Experimental | 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/loz/no email/lite website/full booklet | Experimental | 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/no loz/emails/full website/brief booklet | Experimental | 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/no loz/emails/lite website/full booklet | Experimental | 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/no loz/no email/full website/full booklet | Experimental | 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 |
|
| No CIS/loz/emails/full website/brief booklet | Experimental | 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 |
|
| No CIS/loz/emails/lite website/full booklet | Experimental | 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 |
|
| No CIS/loz/no emails/full website/full booklet | Experimental | 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 |
|
| no CIS/no loz/emails/full website/full booklet | Experimental | 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 |
|
| CIS/loz/emails/full website/brief booklet | Experimental | 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/loz/emails/lite website/full booklet | Experimental | 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 |
|
| No CIS/loz/emails/full website/full booklet | Experimental | 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 |
|
| CIS/no loz/emails/full website/full booklet | Experimental | 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/Loz/no Emails/Full Website/Full Booklet | Experimental | 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/Loz/Emails/Full Website/Full Booklet | Experimental | 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 |
|
| Lozenge - nicotine mini-lozenges | Other | 2-week starter pack of nicotine mini-lozenges |
|
| Emails - Brief smoking prevention messages | Other | Brief email messages that could be accessed by any computer or mobile device that allowed email receipt |
|
| Full website - standard smokefree.gov website content | Other | Over 50 web pages of resources for quitting smoking, including interactive features and referral links |
|
| Lite website - lite version of smokefree.gov | Other | 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 | Other | NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse |
|
| brief mailed booklet - smaller version of NCI's booklet | Other | 12-page booklet developed by the investigators for the research (considered to be placebo intervention) |
|
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. |
| 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. | We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes. | 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 | We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group. | Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. |
| Perceived Support | We will measure perceived support from both treatment and non-treatment resources. | Measured at the1 month, 3 month and 7 month follow up assessments. |
| 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. | Measured at the 1 month, 3 month and 7 month follow up assessments |
| 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. | Measured at the 1 month, 3 month and 7 month follow up assessments. |
| FG003 | No CIS/no Loz/Email/Lite Website/Brief Booklet |
| FG004 | No CIS/No Loz/No Email/Full Website/Brief Booklet |
| FG005 | No CIS/No Loz/No Email/Lite Website/Full Booklet |
| FG006 | CIS/Loz/No Email/Lite Website/Brief Booklet |
| FG007 | CIS/No Loz/Emails/Lite Website/Brief Booklet |
| FG008 | CIS/No Loz/no Email/Full Website/Brief Booklet |
| FG009 | CIS/No Loz/no Email/Lite Website/Full Booklet |
| FG010 | No CIS/Loz/Emails/Lite Website/Brief Booklet |
| FG011 | No CIS/Loz/No Emails/Lite Website/Full Booklet |
| FG012 | No CIS/Loz/No Emails/Full Website/Lite Booklet |
| FG013 | no CIS/no Loz/Emails/Full Website/Brief Booklet |
| FG014 | no CIS/no Loz/Emails/Lite Web/Full Booklet |
| FG015 | no CIS/no Loz/no Email/Full Website/Full Booklet |
| FG016 | CIS/Loz/Emails/Lite Website/Brief Booklet |
| FG017 | CIS/Loz/no Email/Full Website/Brief Booklet |
| FG018 | CIS/Loz/no Email/Lite Website/Full Booklet |
| FG019 | CIS/no Loz/Emails/Full Website/Brief Booklet |
| FG020 | CIS/no Loz/Emails/Lite Website/Full Booklet |
| FG021 | CIS/no Loz/no Email/Full Website/Full Booklet |
| FG022 | No CIS/Loz/Emails/Full Website/Brief Booklet |
| FG023 | No CIS/Loz/Emails/Lite Website/Full Booklet |
| FG024 | No CIS/Loz/no Emails/Full Website/Full Booklet |
| FG025 | no CIS/no Loz/Emails/Full Website/Full Booklet |
| FG026 | CIS/Loz/Emails/Full Website/Brief Booklet |
| FG027 | CIS/Loz/Emails/Lite Website/Full Booklet |
| FG028 | No CIS/Loz/Emails/Full Website/Full Booklet |
| FG029 | CIS/no Loz/Emails/Full Website/Full Booklet |
| FG030 | CIS/Loz/no Emails/Full Website/Full Booklet |
| FG031 | CIS/Loz/Emails/Full Website/Full Booklet |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No CIS/No Loz/No Email/Lite Website/Brief Booklet | |
| BG001 | CIS/No Loz/No Email/Lite Website/Brief Booklet | |
| BG002 | no CIS/Loz/No Email/Lite Website/Brief Booklet | |
| BG003 | No CIS/no Loz/Email/Lite Website/Brief Booklet | |
| BG004 | No CIS/No Loz/No Email/Full Website/Brief Booklet | |
| BG005 | No CIS/No Loz/No Email/Lite Website/Full Booklet | |
| BG006 | CIS/Loz/No Email/Lite Website/Brief Booklet | |
| BG007 | CIS/No Loz/Emails/Lite Website/Brief Booklet | |
| BG008 | CIS/No Loz/no Email/Full Website/Brief Booklet | |
| BG009 | CIS/No Loz/no Email/Lite Website/Full Booklet | |
| BG010 | No CIS/Loz/Emails/Lite Website/Brief Booklet | |
| BG011 | No CIS/Loz/No Emails/Lite Website/Full Booklet | |
| BG012 | No CIS/Loz/No Emails/Full Website/Lite Booklet | |
| BG013 | no CIS/no Loz/Emails/Full Website/Brief Booklet | |
| BG014 | no CIS/no Loz/Emails/Lite Web/Full Booklet | |
| BG015 | no CIS/no Loz/no Email/Full Website/Full Booklet | |
| BG016 | CIS/Loz/Emails/Lite Website/Brief Booklet | |
| BG017 | CIS/Loz/no Email/Full Website/Brief Booklet | |
| BG018 | CIS/Loz/no Email/Lite Website/Full Booklet | |
| BG019 | CIS/no Loz/Emails/Full Website/Brief Booklet | |
| BG020 | CIS/no Loz/Emails/Lite Website/Full Booklet | |
| BG021 | CIS/no Loz/no Email/Full Website/Full Booklet | |
| BG022 | No CIS/Loz/Emails/Full Website/Brief Booklet | |
| BG023 | No CIS/Loz/Emails/Lite Website/Full Booklet | |
| BG024 | No CIS/Loz/no Emails/Full Website/Full Booklet | |
| BG025 | no CIS/no Loz/Emails/Full Website/Full Booklet | |
| BG026 | CIS/Loz/Emails/Full Website/Brief Booklet | |
| BG027 | CIS/Loz/Emails/Lite Website/Full Booklet | |
| BG028 | No CIS/Loz/Emails/Full Website/Full Booklet | |
| BG029 | CIS/no Loz/Emails/Full Website/Full Booklet | |
| BG030 | CIS/Loz/no Emails/Full Website/Full Booklet | |
| BG031 | CIS/Loz/Emails/Full Website/Full Booklet | |
| BG032 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-Day Point-Prevalence Abstinence From Smoking | Abstinence will be defined as 7-day point prevalence. | "Intention to treat (ITT) | Posted | Number | percentage of participants not smoking | Measured after the 3 month follow up assessment |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Smoking Outcomes | Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date. | Not Posted | Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Withdrawal Symptoms | We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group. | Not Posted | Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Perceived Support | We will measure perceived support from both treatment and non-treatment resources. | Not Posted | Measured at the1 month, 3 month and 7 month follow up assessments. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Measured at the 1 month, 3 month and 7 month follow up assessments | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Measured at the 1 month, 3 month and 7 month follow up assessments. |
6 months
Adverse events were only collected for the lozenge condition, since no other treatments had the potential to cause an adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lozenge | 2 week supply of nicotine mini-lozenge. This is the only study arm for which adverse events were appropriate to be collected and analyzed, since all other arms did not involve interventions that could generate an adverse event report. | 0 | 518 | 0 | 518 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stevens Smith, PhD | University of Wisconsin | 608-262-7563 | sss@ctri.wisc.edu |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT. | Regression, Logistic | The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates. | .028 | P-value is not adjusted for multiple comparisons | Odds Ratio (OR) | 1.17 | 2-Sided | 95 | 1.02 | 1.36 | No | Superiority or Other |
| Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging. | Regression, Logistic | The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates. | .755 | P-value is not adjusted for multiple comparisons | Odds Ratio (OR) | 1.02 | 2-Sided | 95 | 0.85 | 1.13 | No | Superiority or Other |
| Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website . | Regression, Logistic | The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates. | .057 | P-value is not adjusted for multiple comparisons | Odds Ratio (OR) | 1.15 | 2-Sided | 95 | 0.996 | 1.33 | No | Superiority or Other |
| Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet. | Regression, Logistic | The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates. | .555 | P-value is not adjusted for multiple comparisons | Odds Ratio (OR) | 0.96 | 95 | 0.83 | 1.11 | No | Superiority or Other |