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Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources

Evaluation of NCI Smoking Intervention Resources

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01342523
Acronym
NCI
Enrollment
1034
Registered
2011-04-27
Start date
2011-10-31
Completion date
2013-10-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Smoking, Smoking Cessation

Keywords

Smoking Cessation, Smoking, Nicotine

Brief 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

Interventions

OTHERCIS - telephone cessation quitline counseling

Up to 5 total tobacco cessation counseling calls

OTHERLozenge - nicotine mini-lozenges

2-week starter pack of nicotine mini-lozenges

OTHEREmails - Brief smoking prevention messages

Brief email messages that could be accessed by any computer or mobile device that allowed email receipt

OTHERFull website - standard smokefree.gov website content

Over 50 web pages of resources for quitting smoking, including interactive features and referral links

OTHERLite 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)

OTHERFull mailed booklet - NCI's detailed 36-page quit guide

NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse

OTHERbrief mailed booklet - smaller version of NCI's booklet

12-page booklet developed by the investigators for the research (considered to be placebo intervention)

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fred Hutchinson Cancer Center
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
7-Day Point-Prevalence Abstinence From SmokingMeasured after the 3 month follow up assessmentAbstinence will be defined as 7-day point prevalence.

Secondary

MeasureTime frameDescription
Resource Use/EngagementAssessed 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.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.
Effectiveness of the Experimental Resources.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.We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.
Withdrawal SymptomsMeasured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.
Smoking OutcomesMeasured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.
Treatment SatisfactionMeasured at the 1 month, 3 month and 7 month follow up assessmentsWe 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.
Increased Quit AttemptsMeasured at the 1 month, 3 month and 7 month follow up assessments.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.
Perceived SupportMeasured at the1 month, 3 month and 7 month follow up assessments.We will measure perceived support from both treatment and non-treatment resources.

Countries

United States

Participant flow

Recruitment details

The recruitment period ran from November 28, 2011 through March 26, 2013. All study participants were recruited through the portal to the smokefree.gov website.

Pre-assignment details

Prior to randomization, potential participants were asked to make a confirmation call to an automated answering system to confirm willingness to perform study procedures. The call was intended to increase the likelihood that individuals would take treatment and follow-up calls. Randomization occurred immediately after the confirmation call.

Participants by arm

ArmCount
No CIS/No Loz/No Email/Lite Website/Brief Booklet35
CIS/No Loz/No Email/Lite Website/Brief Booklet32
no CIS/Loz/No Email/Lite Website/Brief Booklet36
No CIS/no Loz/Email/Lite Website/Brief Booklet33
No CIS/No Loz/No Email/Full Website/Brief Booklet36
No CIS/No Loz/No Email/Lite Website/Full Booklet36
CIS/Loz/No Email/Lite Website/Brief Booklet22
CIS/No Loz/Emails/Lite Website/Brief Booklet27
CIS/No Loz/no Email/Full Website/Brief Booklet28
CIS/No Loz/no Email/Lite Website/Full Booklet28
No CIS/Loz/Emails/Lite Website/Brief Booklet38
No CIS/Loz/No Emails/Lite Website/Full Booklet38
No CIS/Loz/No Emails/Full Website/Lite Booklet39
no CIS/no Loz/Emails/Full Website/Brief Booklet38
no CIS/no Loz/Emails/Lite Web/Full Booklet38
no CIS/no Loz/no Email/Full Website/Full Booklet32
CIS/Loz/Emails/Lite Website/Brief Booklet29
CIS/Loz/no Email/Full Website/Brief Booklet27
CIS/Loz/no Email/Lite Website/Full Booklet21
CIS/no Loz/Emails/Full Website/Brief Booklet27
CIS/no Loz/Emails/Lite Website/Full Booklet29
CIS/no Loz/no Email/Full Website/Full Booklet30
No CIS/Loz/Emails/Full Website/Brief Booklet36
No CIS/Loz/Emails/Lite Website/Full Booklet36
No CIS/Loz/no Emails/Full Website/Full Booklet37
no CIS/no Loz/Emails/Full Website/Full Booklet38
CIS/Loz/Emails/Full Website/Brief Booklet34
CIS/Loz/Emails/Lite Website/Full Booklet31
No CIS/Loz/Emails/Full Website/Full Booklet35
CIS/no Loz/Emails/Full Website/Full Booklet29
CIS/Loz/no Emails/Full Website/Full Booklet31
CIS/Loz/Emails/Full Website/Full Booklet28
Total1,034

Baseline characteristics

CharacteristicCIS/No Loz/No Email/Lite Website/Brief Bookletno CIS/Loz/No Email/Lite Website/Brief BookletNo CIS/no Loz/Email/Lite Website/Brief BookletNo CIS/No Loz/No Email/Full Website/Brief BookletNo CIS/No Loz/No Email/Lite Website/Full BookletCIS/Loz/No Email/Lite Website/Brief BookletCIS/No Loz/Emails/Lite Website/Brief BookletCIS/No Loz/no Email/Full Website/Brief BookletCIS/No Loz/no Email/Lite Website/Full BookletNo CIS/Loz/Emails/Lite Website/Brief BookletNo CIS/Loz/No Emails/Lite Website/Full BookletNo CIS/Loz/No Emails/Full Website/Lite Bookletno CIS/no Loz/Emails/Full Website/Brief Bookletno CIS/no Loz/Emails/Lite Web/Full Bookletno CIS/no Loz/no Email/Full Website/Full BookletCIS/Loz/Emails/Lite Website/Brief BookletNo CIS/No Loz/No Email/Lite Website/Brief BookletCIS/Loz/no Email/Full Website/Brief BookletCIS/Loz/no Email/Lite Website/Full BookletCIS/no Loz/Emails/Full Website/Brief BookletCIS/no Loz/Emails/Lite Website/Full BookletCIS/no Loz/no Email/Full Website/Full BookletNo CIS/Loz/Emails/Full Website/Brief BookletNo CIS/Loz/Emails/Lite Website/Full BookletNo CIS/Loz/no Emails/Full Website/Full Bookletno CIS/no Loz/Emails/Full Website/Full BookletCIS/Loz/Emails/Full Website/Brief BookletCIS/Loz/Emails/Lite Website/Full BookletNo CIS/Loz/Emails/Full Website/Full BookletCIS/no Loz/Emails/Full Website/Full BookletCIS/Loz/no Emails/Full Website/Full BookletCIS/Loz/Emails/Full Website/Full BookletTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants5 Participants
Age, Categorical
>=65 years
0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants2 Participants1 Participants1 Participants0 Participants1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants2 Participants0 Participants1 Participants1 Participants1 Participants1 Participants2 Participants0 Participants0 Participants1 Participants1 Participants21 Participants
Age, Categorical
Between 18 and 65 years
32 Participants35 Participants32 Participants36 Participants36 Participants22 Participants26 Participants27 Participants28 Participants38 Participants38 Participants37 Participants37 Participants37 Participants32 Participants28 Participants34 Participants25 Participants21 Participants27 Participants29 Participants27 Participants36 Participants35 Participants35 Participants37 Participants33 Participants29 Participants35 Participants28 Participants29 Participants27 Participants1008 Participants
Age, Continuous41.97 years
STANDARD_DEVIATION 12.124
39.47 years
STANDARD_DEVIATION 11.661
40.58 years
STANDARD_DEVIATION 13.709
39.89 years
STANDARD_DEVIATION 12.132
39.92 years
STANDARD_DEVIATION 13
40.5 years
STANDARD_DEVIATION 11.859
38.52 years
STANDARD_DEVIATION 14.091
37.71 years
STANDARD_DEVIATION 13.16
38.11 years
STANDARD_DEVIATION 13.076
39 years
STANDARD_DEVIATION 12.192
39.16 years
STANDARD_DEVIATION 10.812
36.03 years
STANDARD_DEVIATION 11.957
39.47 years
STANDARD_DEVIATION 12.967
38.18 years
STANDARD_DEVIATION 11.925
40.56 years
STANDARD_DEVIATION 11.007
42.31 years
STANDARD_DEVIATION 13.134
38.8 years
STANDARD_DEVIATION 13.117
43.04 years
STANDARD_DEVIATION 12.738
35.76 years
STANDARD_DEVIATION 12.373
39.26 years
STANDARD_DEVIATION 10.376
37.79 years
STANDARD_DEVIATION 10.115
40.37 years
STANDARD_DEVIATION 13.433
38.81 years
STANDARD_DEVIATION 11.112
42.97 years
STANDARD_DEVIATION 13.716
38.92 years
STANDARD_DEVIATION 13.215
40.32 years
STANDARD_DEVIATION 11.242
38.47 years
STANDARD_DEVIATION 12.31
37.77 years
STANDARD_DEVIATION 13.386
36.91 years
STANDARD_DEVIATION 10.441
35.62 years
STANDARD_DEVIATION 12.754
38.23 years
STANDARD_DEVIATION 13.674
42.54 years
STANDARD_DEVIATION 12.96
39.28 years
STANDARD_DEVIATION 12.343
Region of Enrollment
United States
32 participants36 participants33 participants36 participants36 participants22 participants27 participants28 participants28 participants38 participants38 participants39 participants38 participants38 participants32 participants29 participants35 participants27 participants21 participants27 participants29 participants30 participants36 participants36 participants37 participants38 participants34 participants31 participants35 participants29 participants31 participants28 participants1034 participants
Sex: Female, Male
Female
18 Participants27 Participants23 Participants21 Participants23 Participants19 Participants19 Participants19 Participants23 Participants24 Participants25 Participants25 Participants21 Participants26 Participants23 Participants23 Participants20 Participants21 Participants13 Participants19 Participants17 Participants19 Participants23 Participants28 Participants28 Participants25 Participants18 Participants24 Participants22 Participants20 Participants25 Participants22 Participants703 Participants
Sex: Female, Male
Male
14 Participants9 Participants10 Participants15 Participants13 Participants3 Participants8 Participants9 Participants5 Participants14 Participants13 Participants14 Participants17 Participants12 Participants9 Participants6 Participants15 Participants6 Participants8 Participants8 Participants12 Participants11 Participants13 Participants8 Participants9 Participants13 Participants16 Participants7 Participants13 Participants9 Participants6 Participants6 Participants331 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 518
serious
Total, serious adverse events
0 / 518

Outcome results

Primary

7-Day Point-Prevalence Abstinence From Smoking

Abstinence will be defined as 7-day point prevalence.

Time frame: Measured after the 3 month follow up assessment

Population: Intention to treat (ITT)

ArmMeasureValue (NUMBER)
Cancer Information Service Counseling (CIS)7-Day Point-Prevalence Abstinence From Smoking27.8 percentage of participants not smoking
No Cancer Information Service Counseling (No CIS)7-Day Point-Prevalence Abstinence From Smoking26.3 percentage of participants not smoking
Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks)7-Day Point-Prevalence Abstinence From Smoking30.5 percentage of participants not smoking
No Nicotine Replacement Therapy7-Day Point-Prevalence Abstinence From Smoking23.4 percentage of participants not smoking
Email Messaging7-Day Point-Prevalence Abstinence From Smoking26.2 percentage of participants not smoking
No Email Messaging7-Day Point-Prevalence Abstinence From Smoking27.8 percentage of participants not smoking
Full SmokeFree.Gov Website7-Day Point-Prevalence Abstinence From Smoking29.5 percentage of participants not smoking
Lite SmokeFree.Gov Website7-Day Point-Prevalence Abstinence From Smoking24.4 percentage of participants not smoking
Full Cessation Booklet7-Day Point-Prevalence Abstinence From Smoking26.3 percentage of participants not smoking
Brief Cessation Booklet7-Day Point-Prevalence Abstinence From Smoking27.7 percentage of participants not smoking
Comparison: Null hypothesis: No difference in 3-month abstinence rates for participants receiving CIS vs No CIS. We hypothesized that CIS would result in significantly higher abstinence rates compared to No CIS.p-value: 0.82595% CI: [0.88, 1.17]Regression, Logistic
Comparison: Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT.p-value: 0.02895% CI: [1.02, 1.36]Regression, Logistic
Comparison: Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging.p-value: 0.75595% CI: [0.85, 1.13]Regression, Logistic
Comparison: Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website .p-value: 0.05795% CI: [0.996, 1.33]Regression, Logistic
Comparison: Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet.p-value: 0.55595% CI: [0.83, 1.11]Regression, Logistic
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.

Time frame: 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.

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.

Time frame: Measured at the 1 month, 3 month and 7 month follow up assessments.

Secondary

Perceived Support

We will measure perceived support from both treatment and non-treatment resources.

Time frame: Measured at the1 month, 3 month and 7 month follow up assessments.

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.

Time frame: 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.

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.

Time frame: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.

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.

Time frame: Measured at the 1 month, 3 month and 7 month follow up assessments

Secondary

Withdrawal Symptoms

We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.

Time frame: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026