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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA155489 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WEB only | Other | Control group receiving no additional intervention |
|
| WEB+SN | Experimental | WEB plus social network intervention. |
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| WEB+NRT | Experimental | WEB plus nicotine replacement therapy product. |
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| WEB+SN+NRT | Experimental | WEB plus social network intervention and nicotine replacement therapy product. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB | Behavioral | Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda L Graham, PhD | Truth Initiative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Truth Initiative | Washington D.C. | District of Columbia | 20001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23414086 | Background | Graham AL, Cha S, Papandonatos GD, Cobb NK, Mushro A, Fang Y, Niaura RS, Abrams DB. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol. Trials. 2013 Feb 17;14:48. doi: 10.1186/1745-6215-14-48. | |
| 24201304 | Background | Graham AL, Cha S, Cobb NK, Fang Y, Niaura RS, Mushro A. Impact of seasonality on recruitment, retention, adherence, and outcomes in a web-based smoking cessation intervention: randomized controlled trial. J Med Internet Res. 2013 Nov 7;15(11):e249. doi: 10.2196/jmir.2880. |
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No current plans, but interested researchers may contact Principal Investigator for additional discussion.
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| ID | Title | Description |
|---|---|---|
| FG000 | WEB Only | Control group receiving no additional intervention WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes baseline characteristics of participants who completed participation in the full study.
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| ID | Title | Description |
|---|---|---|
| BG000 | WEB Only | Control group receiving no additional intervention WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website. |
| BG001 | WEB+SN |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat | Posted | Count of Participants | Participants | 9 months post-randomization |
|
Overall study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WEB Only | Control group receiving no additional intervention WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reaction to Nicotine Replacement Therapy | Product Issues | Non-systematic Assessment | Participants reporting side effects (such as skin irritation) from nicotine replacement therapy product use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda L. Graham, PhD | Truth Initiative | 202-454-5938 | agraham@truthinitiative.org |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D009538 | Nicotine |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
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|
| Social Network | Behavioral | 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) | Behavioral | 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. |
|
|
| 25542911 | Background | Pearson JL, Stanton CA, Cha S, Niaura RS, Luta G, Graham AL. E-Cigarettes and Smoking Cessation: Insights and Cautions From a Secondary Analysis of Data From a Study of Online Treatment-Seeking Smokers. Nicotine Tob Res. 2015 Oct;17(10):1219-27. doi: 10.1093/ntr/ntu269. Epub 2014 Dec 26. |
| 27283295 | Background | Cha S, Erar B, Niaura RS, Graham AL. Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial. Ann Behav Med. 2016 Oct;50(5):751-761. doi: 10.1007/s12160-016-9804-x. |
| 29878062 | Derived | Graham AL, Papandonatos GD, Cha S, Erar B, Amato MS. Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial. Ann Behav Med. 2018 Mar 15;52(4):331-341. doi: 10.1093/abm/kax023. |
| Non-smoker |
|
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.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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 | Intent to treat | Posted | Count of Participants | Participants | 3 months post-randomization |
|
|
|
| 0 |
| 1,337 |
| 0 |
| 1,337 |
| EG001 | 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. | 0 | 1,324 | 0 | 1,324 |
| EG002 | 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. | 0 | 1,314 | 4 | 1,314 |
| EG003 | 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. | 0 | 1,317 | 0 | 1,317 |
|
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| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |