NCT01342523

Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources

Evaluation of NCI Smoking Intervention Resources

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,034 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 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

Conditions

• Smoking Cessation
• Smoking
• Nicotine Dependence

Interventions

Type	Name	Description
OTHER	CIS - telephone cessation quitline counseling	Up to 5 total tobacco cessation counseling calls
OTHER	Lozenge - nicotine mini-lozenges	2-week starter pack of nicotine mini-lozenges
OTHER	Emails - Brief smoking prevention messages	Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
OTHER	Full website - standard smokefree.gov website content	Over 50 web pages of resources for quitting smoking, including interactive features and referral links
OTHER	Lite website - lite version of smokefree.gov	Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
OTHER	Full mailed booklet - NCI's detailed 36-page quit guide	NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
OTHER	brief mailed booklet - smaller version of NCI's booklet	12-page booklet developed by the investigators for the research (considered to be placebo intervention)

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-05-01
• Completion: 2013-10-01
• First posted: 2011-04-27
• Last updated: 2015-10-14
• Results posted: 2014-03-05

Locations

1 site across 1 country: United States