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Evaluation of NCI Smoking Intervention Resources


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Smoking Cessation, Smoking, Nicotine Dependence

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Trial Information

Evaluation of NCI Smoking Intervention Resources


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


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.)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Abstinence from smoking

Outcome Description:

Abstinence will be defined in several ways (e.g., 6-month point prevalence, survival).

Outcome Time Frame:

Measured after the 7 month follow up assessment

Safety Issue:

No

Principal Investigator

Timothy B Baker, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2011-0007

NCT ID:

NCT01342523

Start Date:

October 2011

Completion Date:

January 2014

Related Keywords:

  • Smoking Cessation
  • Smoking
  • Nicotine Dependence
  • Smoking Cessation
  • Smoking
  • Nicotine
  • Tobacco Use Disorder
  • Smoking

Name

Location

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public HealthMadison, Wisconsin  53711