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临床试验/NCT03084835
NCT03084835终止不适用

Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年8月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
32
试验地点
2
主要终点
smoking abstinence

研究概览

简要总结

This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.

详细描述

Using a 3-arm randomized trial design with repeated measures at 1, 3, 6, and 12 months, the study will randomize N=1650 smokers who present for LDCT lung cancer screening to an passive referral usual care control condition, proactive referral to a digital cessation intervention that combines web and text messaging, or proactive referral to a digital cessation intervention combined with Tobacco Treatment Specialist counseling. The Study will examine overall effectiveness of the interventions in promoting abstinence, the impact of proactive referral to treatment, and the total cost and cost effectiveness of the interventions. The Study will also examine the representativeness of the enrolled sample and explore barriers and facilitators to intervention adoption with LDCT clinic leaders. The trial is structured as a practical clinical trial to answer key questions of direct relevance to LDCT decision-makers.

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

入选标准

  • Scheduled for LDCT screening
  • Current smoking (every day/some days)
  • At least weekly use of the Internet
  • Current ownership of cell phone with a text messaging plan
  • Willing to receive study text messages.
  • Ability to complete all aspects of the study
  • Ability to provide signed informed consent

排除标准

  • Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment.
  • Those with a condition deemed by the investigators to be exclusionary to the study

研究组 & 干预措施

UC

Active Comparator

Usual Care

干预措施: Usual Care (Behavioral)

WEB+TXT

Active Comparator

Digital Intervention

干预措施: WEB+TXT (Behavioral)

WEB+TXT+TTS

Active Comparator

Digital plus Counseling Intervention

干预措施: WEB+TXT+TTS (Behavioral)

结局指标

主要结局

smoking abstinence

时间窗: 12 months

biochemically confirmed 12 month smoking abstinence of WEB+TXT;

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivana Croghan

Professor of Medicine

Mayo Clinic

研究点 (2)

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