Internet-Based Smoking Cessation for Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

Study Overview
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Brief Summary
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The overarching aim of the study is to evaluate in a randomized trial the impact of an internet intervention compared to a standard clinic-based control group to promote smoking cessation among Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) veterans.

Detailed Description
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Project Background: Veterans returning from Iraq and Afghanistan are smoking at high rates and are at elevated risk for the development of smoking related illness. Intensive speciality clinic-based tobacco cessation programs have high efficacy, are more cost effective than less intensive approaches, and are employed by most VA medical centers. These programs, however, are infrequently attended by veterans, limiting the impact on prevalence, disease burden, and economic costs of smoking. An internet-based smoking cessation intervention could be an effective, low-cost method to implement evidence based smoking cessation principles. The internet could significantly increase the impact of smoking cessation efforts over current approaches by avoiding barriers that limit utilization of existing clinic-based services. Project Objectives: The goal of the study is to evaluate the impact of an internet-based intervention in comparison to standard VA speciality clinic-based care in promoting smoking cessation in returning veterans. Accordingly, the specific aims and hypotheses are: AIM 1: To evaluate the impact of an internet-based smoking cessation intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 3 months and 12-month post-treatment follow-ups. Hypothesis 1: Abstinence rates will be significantly higher among veterans randomized to the web-based intervention than those randomized to VA specialty cessation care. AIM 2: To evaluate the impact of an internet-based smoking cessation intervention on reach of smoking cessation treatment. Hypothesis 2.1: Internet-based treatment will result in increased reach as measured by the proportion of patients who access care. Hypothesis 2.2: Internet-based treatment will result in engagement in treatment as measured by the proportion of patients that make at least one quit attempt. AIM 3: To evaluate the relative cost-effectiveness of the standard specialty care intervention to the web-based intervention. Project Methods: Proposed is a trial in which 410 OEF/OIF veteran smokers will be randomized to receive either an internet-based smoking cessation intervention and nicotine replacement therapy or referral to VA specialty smoking cessation care, which includes behavioral therapy, group counseling, telephone counseling, self-help materials, and choice of smoking cessation aid (pharmacotherapy). Participating patients will be surveyed at 3 months post-intervention and at 12 months. The primary outcome of the trial is a 7-day point prevalence abstinence at the 3-month post intervention follow-up, as measured by self-report and verified by cotinine assay.

Official Title
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Internet-Based Smoking Cessation for OEF/OIF Veterans

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Internet-based
* Behavioral: Standard Clinic-Based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in DVAMC for ongoing care Served during OEF/OIF Current smokers willing to make a quit attempt in the next 30 days Exclusion Criteria: Active diagnosis of psychosis in the medical record Diagnosis of severe dementia in the medical record Does not have access to a telephone Severely impaired hearing or speech (veterans must be able to respond to phone calls) Refusal to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Internet-based smoking cessation | Behavioral: Internet-based<br>* Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services.<br>* Other names: Intervention;|
| Other: Arm 2<br>Clinic-based smoking cessation | Behavioral: Standard Clinic-Based<br>* Veterans randomized to the control condition will have a consult placed to the Durham VA Medical Center (DVAMC) specialty Smoking Cessation Clinic placed on their behalf.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence) |  | 3 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, Smoking cessation, Operation Enduring Freedom, Operation Iraqi Freedom