Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01342523
Other study ID # 2011-0007
Secondary ID
Status Completed
Phase Phase 4
First received March 8, 2011
Last updated October 9, 2015
Start date October 2011
Est. completion date October 2013

Study information

Verified date October 2015
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1034
Est. completion date October 2013
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.)

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison Fred Hutchinson Cancer Research Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 7-Day Point-Prevalence Abstinence From Smoking Abstinence will be defined as 7-day point prevalence. Measured after the 3 month follow up assessment No
Secondary Smoking Outcomes Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date. Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. No
Secondary Resource Use/Engagement 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. 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. No
Secondary Effectiveness of the Experimental Resources. We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes. 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. No
Secondary Withdrawal Symptoms We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group. Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments. No
Secondary Perceived Support We will measure perceived support from both treatment and non-treatment resources. Measured at the1 month, 3 month and 7 month follow up assessments. No
Secondary Treatment Satisfaction 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. Measured at the 1 month, 3 month and 7 month follow up assessments No
Secondary Increased Quit Attempts 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. Measured at the 1 month, 3 month and 7 month follow up assessments. No
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A