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临床试验/NCT00589277
NCT00589277已完成1 期

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

Yale University2 个研究点 分布在 1 个国家目标入组 2,032 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
2,032
试验地点
2
主要终点
Quit Attempt

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18+ years)
  • New York State residents
  • English-speaking
  • Current smokers who utilize Quitline services seeking quitting assistance for themselves

排除标准

  • Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county

结局指标

主要结局

Quit Attempt

时间窗: 2 week follow up

Percentage of those that self reported attempting to quit smoking at the 2 week follow up.

次要结局

  • 24 Hour Abstinence(2 week follow up)
  • 7 Day Abstinence(3 month follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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