Smoking Cessation
Conditions
Keywords
Web based behavioral intervention, Adherence, Smoking cessation, Social network, Nicotine replacement therapy, Social support
Brief summary
This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.
Detailed description
This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT. Using a 2 (SN integration, no SN) x 2 (access to free NRT, no access) randomized, controlled factorial design with repeated measures at baseline, 3, and 9 months, this study will recruit N=5,000 new members of a Web-based smoking cessation program and randomize them to: 1) WEB, 2) WEB+SN, 3) WEB+NRT, or 4) WEB+SN+NRT. Aim 1: To evaluate the comparative efficacy of WEB+SN, WEB+NRT, and WEB+SN+NRT versus WEB alone with regard to self-reported 30-day point prevalence abstinence at the primary endpoint of 9 months and at secondary endpoint of 3 months. Hypothesis 1a: All three intervention conditions will outperform WEB. Hypothesis 1b: WEB+SN+NRT will outperform WEB+SN and WEB+NRT. Aim 2: To examine whether the impact of treatment condition on cessation is mediated by greater adherence to problem solving/skills training tools, social support, and pharmacotherapy. Hypothesis 2: WEB+SN+NRT will have the greatest impact on treatment adherence, which will yield higher quit rates than the other treatments. Exploratory Aim: To advance theory and identify the processes through which social network integration and provision of free NRT influence treatment adherence. Specifically, exploratory analyses will examine whether social support and social norms are active elements in the pathway to adherence, along with other known mediators of abstinence such as self-efficacy.
Interventions
BEHAVIORALWEB
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
BEHAVIORALSocial Network
Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.
BEHAVIORALNicotine Replacement Therapy (NRT)
A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
Sponsors
National Cancer Institute (NCI)
Truth Initiative
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
* Age 18 years and older * Current smoker * Registered user on BecomeAnEX.org
Exclusion criteria
* Pregnant or breastfeeding * Cardiovascular conditions * Current use of any stop smoking medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day Point Prevalence Abstinence | 9 months post-randomization | In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day Point Prevalence Abstinence | 3 months post-randomization | In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WEB Only Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website. | 1,337 |
| WEB+SN WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org. | 1,323 |
| WEB+NRT WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own. | 1,313 |
| WEB+SN+NRT WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own. | 1,317 |
| Total | 5,290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Non-smoker | 0 | 0 | 1 | 0 |
| Overall Study | Under 18 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | WEB Only | WEB+SN | WEB+NRT | WEB+SN+NRT |
|---|---|---|---|---|---|
| Age, Customized 18-24 years old | 548 Participants | 131 Participants | 128 Participants | 140 Participants | 149 Participants |
| Age, Customized < 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 25-44 years old | 2395 Participants | 573 Participants | 615 Participants | 601 Participants | 606 Participants |
| Age, Customized 45-64 years old | 2121 Participants | 567 Participants | 522 Participants | 522 Participants | 510 Participants |
| Age, Customized >=65 years | 226 Participants | 66 Participants | 58 Participants | 50 Participants | 52 Participants |
| Education College Graduate | 1212 Participants | 309 Participants | 315 Participants | 303 Participants | 285 Participants |
| Education High School Graduate | 1200 Participants | 319 Participants | 279 Participants | 293 Participants | 309 Participants |
| Education Some College | 2631 Participants | 643 Participants | 672 Participants | 658 Participants | 658 Participants |
| Education Some High School or Less | 247 Participants | 66 Participants | 57 Participants | 59 Participants | 65 Participants |
| Education Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Employment Employed Full-Time | 2402 Participants | 597 Participants | 614 Participants | 608 Participants | 583 Participants |
| Employment Not Employed Full-Time | 2888 Participants | 740 Participants | 709 Participants | 705 Participants | 734 Participants |
| Employment Unkown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Has a Partner | 2735 Participants | 695 Participants | 714 Participants | 665 Participants | 661 Participants |
| Marital Status No Partner | 2555 Participants | 642 Participants | 609 Participants | 648 Participants | 656 Participants |
| Marital Status Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 114 Participants | 34 Participants | 18 Participants | 29 Participants | 33 Participants |
| Race/Ethnicity, Customized Asian | 82 Participants | 14 Participants | 25 Participants | 17 Participants | 26 Participants |
| Race/Ethnicity, Customized Black or African American | 802 Participants | 216 Participants | 193 Participants | 209 Participants | 184 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 294 Participants | 80 Participants | 82 Participants | 61 Participants | 71 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 55 Participants | 13 Participants | 14 Participants | 14 Participants | 14 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 4996 Participants | 1257 Participants | 1241 Participants | 1252 Participants | 1246 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 4237 Participants | 1060 Participants | 1073 Participants | 1044 Participants | 1060 Participants |
| Region of Enrollment United States | 5290 participants | 1337 participants | 1323 participants | 1313 participants | 1317 participants |
| Sex/Gender, Customized Female | 3217 Participants | 822 Participants | 809 Participants | 788 Participants | 798 Participants |
| Sex/Gender, Customized Male | 2073 Participants | 515 Participants | 514 Participants | 525 Participants | 519 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,337 | 0 / 1,324 | 4 / 1,314 | 0 / 1,317 |
| serious Total, serious adverse events | 0 / 1,337 | 0 / 1,324 | 0 / 1,314 | 0 / 1,317 |
Outcome results
Primary
Self-reported 30-day Point Prevalence Abstinence
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence.
Time frame: 9 months post-randomization
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WEB Only | Self-reported 30-day Point Prevalence Abstinence | 166 Participants |
| WEB+SN | Self-reported 30-day Point Prevalence Abstinence | 146 Participants |
| WEB+NRT | Self-reported 30-day Point Prevalence Abstinence | 182 Participants |
| WEB+SN+NRT | Self-reported 30-day Point Prevalence Abstinence | 184 Participants |
Secondary
Self-reported 30-day Point Prevalence Abstinence
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence
Time frame: 3 months post-randomization
Population: Intent to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WEB Only | Self-reported 30-day Point Prevalence Abstinence | 164 Participants |
| WEB+SN | Self-reported 30-day Point Prevalence Abstinence | 129 Participants |
| WEB+NRT | Self-reported 30-day Point Prevalence Abstinence | 190 Participants |
| WEB+SN+NRT | Self-reported 30-day Point Prevalence Abstinence | 201 Participants |