Message Framing for Telephone Quitline Callers

Study Overview
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Brief Summary
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The purpose of this study is to compare gain-framed counseling + gain-framed materials to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.

Detailed Description
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This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively Gain-framed counseling + gain-framed materials to standard care Quitline counseling + standard print materials will be conducted with individuals calling the NYS Smokers' Quitline for assistance in quitting smoking. Following assessment of eligibility and informed consent, 2,500 smokers will be assisted by Specialists in either the YC or SC experimental conditions. Consistent with the current practices of the Quitline, following the counseling intervention, participants will be mailed a package containing print materials encouraging smoking cessation, and participants eligible for Nicotine replacement therapy (NRT) will receive a 2-week supply of nicotine replacement medication. Consistent with Quitline practices, all callers will be required to set a quit date within 2 weeks of their initial call. A Quitline Specialist will initiate a follow-up call approximately 10 to 14 days after the print materials and NRT has been mailed. For callers receiving NRT, the manufacturer's suggested course of therapy (e.g., 8 weeks of NRT) will be recited to callers, and Quitline Specialists will suggest that callers use the money they save from not smoking to purchase additional NRT and/or that they check with their insurance carrier to see if additional NRT would be covered. Participants will be assessed before receiving the gain-framed counseling + gain-framed materials or standard care counseling, immediately after receiving counseling, approximately 1 week after their quit date for those who receive NRT, and at a 3-month follow-up to see if the gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered.

Official Title
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Promoting Tobacco and Cancer Control: Message Framing for Telephone Quitline Callers

Conditions
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Smoking, Nicotine Dependence

Intervention / Treatment
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* Behavioral: Gain-Framed counseling & Gain-framed materials
* Behavioral: Standard care counseling + standard materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18+ years) New York State residents English-speaking Current smokers who utilize Quitline services seeking quitting assistance for themselves Exclusion Criteria: Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gain-Framed counseling & Gain-framed materials<br>Novel messages for quitting smoking | Behavioral: Gain-Framed counseling & Gain-framed materials<br>* Novel messages for quitting smoking<br>|
| Placebo Comparator: Standard care counseling + standard materials<br>Standard care counseling + standard care print information | Behavioral: Standard care counseling + standard materials<br>* Standard messages for quitting smoking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit Attempt | Percentage of those that self reported attempting to quit smoking at the 2 week follow up. | 2 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Abstinence | The number of survey respondents that had abstained from smoking at the 2 week follow up. | 2 week follow up | 
| 7 Day Abstinence | The number of survey respondents that had abstained from smoking for 7 days at the 3 month follow up. | 3 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Tobacco, Message Framing