Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach
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
- 是
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
Usual Care
干预措施: Usual Care (Behavioral)
WEB+TXT
Digital Intervention
干预措施: WEB+TXT (Behavioral)
WEB+TXT+TTS
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
