Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources

• Abstinence from smoking [ Time Frame: Measured after the 7 month follow up assessment ] [ Designated as safety issue: No ]
  Abstinence will be defined in several ways (e.g., 6-month point prevalence, survival).
  
  

• Smoking outcomes [ Time Frame: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. ] [ Designated as safety issue: No ]
  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 [ 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. ] [ Designated as safety issue: No ]
  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. [ 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. ] [ Designated as safety issue: No ]
  We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.
  
  
• Withdrawal symptoms [ Time Frame: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. ] [ Designated as safety issue: No ]
  We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.
  
  
• Perceived support [ Time Frame: Measured at the1 month, 3 month and 7 month follow up assessments. ] [ Designated as safety issue: No ]
  We will measure perceived support from both treatment and non-treatment resources.
  
  
• Treatment satisfaction [ Time Frame: Measured at the 1 month, 3 month and 7 month follow up assessments ] [ Designated as safety issue: No ]
  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 [ Time Frame: Measured at the 1 month, 3 month and 7 month follow up assessments. ] [ Designated as safety issue: No ]
  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.
  
  

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