Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources
Condition: Smoking Cessation; Smoking; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: CIS - telephone cessation quitline counseling; Lozenge - nicotine mini-lozenges; Emails - Brief smoking prevention messages; Full website - standard smokefree.gov website content; Lite website - lite version of smokefree.gov; Full mailed booklet - NCI's detailed 36-page quit guide; brief mailed booklet - smaller version of NCI's booklet
Intervention description: 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)
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 1034.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Smoking; Nicotine

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.
    

Eligibility criteria:

        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.)