跳至主要内容
临床试验/NCT03069924
NCT03069924已完成2 期

Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 367 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
367
试验地点
2
主要终点
Smoking Cessation - Available Data

研究概览

简要总结

This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •50 years or older
  • •at least a 20-pack year history of smoking
  • •current smoker (defined as any smoking in the past 30 days)
  • •willing to be randomized
  • •English speaking

排除标准

  • •unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
  • •known allergy to adhesives
  • •being in the immediate (within 2 weeks) post myocardial infarction period
  • •serious arrhythmias
  • •unstable angina pectoris
  • •hemodynamically or electrically unstable.
  • •current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)

研究组 & 干预措施

Unframed Messaging

Active Comparator

Unframed smoking cessation materials

干预措施: Unframed messaging materials (Combination Product)

Gain-framed Messaging

Experimental

Gain-framed messaging

干预措施: Gain-framed messaging (Behavioral)

结局指标

主要结局

Smoking Cessation - Available Data

时间窗: 6 month follow-up

Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit

次要结局

  • Cigarettes Smoked Per Day - Average(6 month follow-up)
  • Smoking Cessation - Imputed(6 Month Follow up Visit)

研究者

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

Benjamin Toll

Professor

Medical University of South Carolina

研究点 (2)

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