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: 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,034
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)
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States
7-Day Point-Prevalence Abstinence From Smoking
Abstinence will be defined as 7-day point prevalence.
Time frame: Measured after the 3 month follow up assessment
Smoking Outcomes
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.
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.
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.
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.
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.
Withdrawal Symptoms
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.
Perceived Support
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.
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.
Time frame: 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.
Time frame: Measured at the 1 month, 3 month and 7 month follow up assessments.
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