Smoking Cessation Clinical Trial
Official title:
Evaluation of NCI Smoking Intervention Resources
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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