CONNECT: Smoking Cessation and Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Number of participants with Self-reported quit attempts
研究概览
简要总结
This clinical trial studies the impact of CONNECT on biochemically confirmed smoking abstinence among diverse current smokers who are undergoing lung cancer screening.
详细描述
The study team will develop and test a novel smoking cessation intervention, CONNECT, which will start at the time an individual is receiving lung cancer screening (LCS). CONNECT will include an interactive Video Doctor which will provide participants with information tailored to their individual responses as well as proactive outreach using brief telephone calls and text messaging to follow up smokers with motivation enhancement to refer and engage patients in evidence based smoking cessation interventions (such as quitline utilization). After development and usability testing, we will conduct a small feasibility study followed by a pilot randomized controlled trial to estimate the impact of CONNECT on biochemically confirmed 30-day smoking abstinence among diverse current smokers seen at the San Francisco Veterans Affairs Medical Center and the University of California San Francisco Division of General Internal Medicine. Participants will be randomized to CONNECT or a control condition. Data will include self-report from participants obtained at baseline, 1 and 3 months, and the electronic health record. Outcomes will be biochemically confirmed 30-day smoking abstinence at 3 months post LCS and satisfaction as well as self-reported quit attempts, and use of evidence-based smoking cessation resources (quitline, pharmacotherapy or counseling). The knowledge gained will provide the pilot data necessary to apply for a larger study to test our novel intervention for promoting smoking cessation among a diverse population of high-risk smokers undergoing Lung Cancer Screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Age 55-80
- •Male or female
- •English speaking
- •Have an already scheduled low-dose computed tomography (LDCT) visit
- •Smoke at least 1 cigarette in the last 7 days
- •Have a phone that can receive text messages.
排除标准
- •Younger than 55 or older than 80
- •Does not speak English
- •Does not have a scheduled low-dose computed tomography (LDCT) visit
- •Does not smoke at least 1 cigarette in the last 7 days
- •Does not have a phone that can receive text messages.
研究组 & 干预措施
Experimental: Intervention Group (CONNECT)
Patients complete CONNECT, the Video Doctor over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment.
干预措施: Computer-Assisted Intervention Video Doctor (Other)
Control Group
Patients complete CONNECT assessment only over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment.
Individuals who are randomized to the control group will undergo the same assessment questions and all follow up assessments like the intervention group. Instead of viewing and participating in the interactive Video Doctor about Smoking Cessation, they receive a handout containing smoking cessation resources.
干预措施: Computer-Assisted Intervention no Video Doctor (Other)
结局指标
主要结局
Number of participants with Self-reported quit attempts
时间窗: Up to 3 months from date of lung cancer screening appointment.
Self-reported quit attempts will be measured to assess smoking behavioral changes.
Percentage of participants who used of evidence-based smoking cessation resources
时间窗: Up to 3 months from date of lung cancer screening appointment.
Use of evidence-based smoking cessation resources such as quitline, pharmacotherapy or counseling will be measured to assess smoking behavioral changes.
Assessing 30-day smoking abstinence at 3 months post lung cancer screening.
时间窗: Up to 3 months from date of lung cancer screening appointment.
Biochemically confirmed 30-day smoking abstinence at 3 months post lung cancer screening.
次要结局
- Change in Participation rate over time(Up to 18 months.)
- Change in intervention component completion rates over time(Up to 18 months.)
