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临床试验/NCT02267096
NCT02267096已完成3 期

Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening

Georgetown University6 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
95
试验地点
6
主要终点
Smoking Status with biochemical verification

研究概览

简要总结

In 2011, the National Lung Screening Trial (NLST) reported that lung cancer mortality was reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. It is estimated that 8 million people in the US are at high risk for lung cancer and that lung screening could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent smoking cessation programs will be essential in order to realize the full benefit of screening. However, there are no clinical guidelines or evidence-based cessation protocols with demonstrated effectiveness in this setting. The investigators are addressing this gap by rigorously testing whether two scalable and pragmatic interventions can significantly boost intention to quit and cessation rates.

详细描述

Although abstinence from tobacco remains the best method of lung cancer prevention, recent evidence from the National Lung Screening Trial indicated that lung cancer mortality was reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. As a result, the United States Preventive Services Task Force now recommends lung cancer screening for high risk individuals (long-term current and former smokers, 55-80 years old). It is estimated that 8 million people in the US are at high risk and that lung screening could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent smoking cessation programs will be essential in order to realize the full benefit of screening. However, there are no clinical guidelines or evidence-based cessation protocols with demonstrated effectiveness in this setting. The investigators propose to address this gap by rigorously testing whether two scalable and pragmatic interventions (minimal and moderate in intensity) can significantly boost intention to quit and cessation rates. The investigators will capitalize on the critical 'teachable moment' of learning of one's screening result. Incorporation of an individual's screening result into a cessation intervention will test the innovative question of whether intention to quit can be enhanced and reduced intention to quit can be minimized, when an individualized, motivational telephone-based intervention is provided. Method: The investigators will accrue current smokers from the lung cancer screening programs at three sites: Georgetown University Hospital, Lahey Hospital, and Hackensack University Hospital. Prior to screening, 100 participants will be consented, enrolled, and will complete the baseline (T0) phone interview. Within 1-2 days of receiving the result, participants will be randomly assigned to Minimal Treatment (MT) vs. Telephone Counseling (TC). Both arms will receive the minimal treatment intervention (a list of print, online, quitline, and in-person cessation resources). The TC arm will receive 3-6 sessions of stepped-care, proactive, telephone counseling with the same Tobacco Treatment Specialist for both sites. Both arms will be assessed at 3-months post randomization for tobacco use outcomes. The specific aims are: 1) To conduct a two-arm randomized cessation intervention trial (MT vs. TC) with current smokers undergoing screening. 2) The investigators will explore moderators and mediators of the interventions' effect on cessation outcomes. Moderators include the screening result, race, gender, age, and nicotine dependence. Mediators include teachable moment factors, baseline intention to quit, and process measures. Summary: This proof of concept study will determine intervention feasibility, effect sizes needed for a larger study, and potential moderators and mediators of the intervention. The long-term goal is to evaluate the intervention in a multisite trial and ultimately, to disseminate it for use by lung cancer screening programs. The innovation of this proposal is in joining disease prevention (smoking cessation) with early detection in a medical setting that has relevance for a substantial proportion of current smokers, suggesting that even a small increase in cessation has the potential for a very large public health benefit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 55-80 years old
  • current smoker
  • > 30-pack years
  • English-speaking
  • ability to provide meaningful consent
  • enrolled to undergo lung cancer screening. -

排除标准

  • history of lung cancer
  • current treatment for other cancer -

结局指标

主要结局

Smoking Status with biochemical verification

时间窗: Measured at 3 months post-randomization

Self-reported 7-day and 30-day point prevalence abstinence with biochemical verification among those who report having quit smoking.

次要结局

  • Quit attempts(Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2))
  • Cigarettes per day(Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2))
  • Timeframe of Participants' Intention to Quit Smoking(Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn L. Taylor, Ph.D.

Professor, Department of Oncology

Georgetown University

研究点 (6)

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