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Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

NCT ID: NCT01544153

Last Updated: 2017-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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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. 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.

Conditions

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Smoking Cessation

Keywords

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Web based behavioral intervention Adherence Smoking cessation Social network Nicotine replacement therapy Social support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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WEB only

Control group receiving no additional intervention

Group Type OTHER

WEB

Intervention Type BEHAVIORAL

Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

WEB+SN

WEB plus social network intervention.

Group Type EXPERIMENTAL

WEB

Intervention Type BEHAVIORAL

Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Social Network

Intervention Type BEHAVIORAL

Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

WEB+NRT

WEB plus nicotine replacement therapy product.

Group Type EXPERIMENTAL

WEB

Intervention Type BEHAVIORAL

Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Nicotine Replacement Therapy (NRT)

Intervention Type 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.

WEB+SN+NRT

WEB plus social network intervention and nicotine replacement therapy product.

Group Type EXPERIMENTAL

WEB

Intervention Type BEHAVIORAL

Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Social Network

Intervention Type 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)

Intervention Type 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.

Interventions

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WEB

Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Intervention Type BEHAVIORAL

Social Network

Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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BecomeAnEX NicoDerm CQ Nicorette Gum Nicorette Lozenge Nicorette Mini-Lozenge

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Truth Initiative

OTHER

Sponsor Role lead

Responsible Party

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Amanda L. Graham, PhD

Director, Research Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda L Graham, PhD

Role: PRINCIPAL_INVESTIGATOR

Truth Initiative

Locations

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Truth Initiative

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23414086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24201304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25542911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27283295 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29878062 (View on PubMed)

Other Identifiers

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1R01CA155489

Identifier Type: NIH

Identifier Source: secondary_id

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1R01CA155489

Identifier Type: NIH

Identifier Source: org_study_id

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