Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 4
- 主要终点
- Smoking Cessation
研究概览
简要总结
The purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction in patients who are screened for lung cancer or are eligible for lung cancer screening. Each intervention will be compared to standard of care. The first intervention will be a personalized message intervention, the second intervention will consist of a biofeedback-based intervention.
详细描述
The primary aims of this study are to test the efficacy two types of smoking cessation methods (compared to standard care).
The aim of the first intervention is to evaluate the efficacy of a personalized message intervention in improving tobacco quit rates above and beyond standard care smoking cessation treatment in patients at risk for lung cancer. Messages will be designed specifically for patients at risk for lung cancer, personalized and presented in a gain-framed manner, taking into account demographics and smoking history.
The aim of the second intervention is to evaluate the efficacy of a novel, biofeedback-based intervention that provides personalized individual-level feedback on biomarkers of lung cancer risk and how they improve in response to cessation, delivered in a gain-framed way. The biomarkers include skin carotenoid status, spirometry, and plasma bilirubin, all of which improve with cessation. The study team will examine whether the biofeedback prevents relapse in those who quit and leads to reductions in smoking in lung nodule patients who failed to quit.
Additionally, this study will attempt to evaluate the impact of smoking cessation on miRNA profiles in human serum, especially miRNAs in the let-7 family, which are known to have tumor suppressor function, and which we hypothesize increase in response to cessation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current Smoker.
- •20 pack per year smoking history.
- •Eligible for the Smilow treatment program.
- •Willing to enroll in smoking cessation program.
- •Willing to be randomized in smoking cessation study.
- •English speaking.
排除标准
- •Dementia or current serious psychiatric or unstable medical illness.
- •Pregnancy or breast feeding.
- •Known fat malabsorption diseases that may affect skin carotenoid status.
结局指标
主要结局
Smoking Cessation
时间窗: 8 weeks
Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
Number of cigarettes smoked
时间窗: 6 months
Number of cigarettes smoked will be assessed by self report. Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
次要结局
- Smoking Cessation(Baseline, 4 Weeks, 3 Months)
- Plasma Bilirubin(Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months)
- Skin Carotenoids(Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months)
- Expired Air(Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months)