Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 374
- 主要终点
- Mortality
研究概览
简要总结
This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.
详细描述
PRIMARY OBJECTIVES:
I. To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.
SECONDARY OBJECTIVES:
I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention (varenicline) and control group (placebo).
II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group (varenicline and behavioral intervention)
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
干预措施: Varenicline (Drug)
Intervention group (varenicline and behavioral intervention)
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
干预措施: Tobacco Cessation Counseling (Other)
Control group (placebo and behavioral intervention)
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
干预措施: Placebo (Drug)
Control group (placebo and behavioral intervention)
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.
干预措施: Tobacco Cessation Counseling (Other)
结局指标
主要结局
Mortality
时间窗: Up to 30 days post-surgery
Number of patients that died within 30 days of surgery
Number of Paticipants With Incidence of Pulmonary Complications
时间窗: Up to 24 weeks post-surgery
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Number of Participants With Incidence of Anastomotic Failure
时间窗: Up to 24 weeks post-surgery
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Number of Participants With Incidence of Unspecified Wound Infection
时间窗: Up to 24 weeks post-surgery
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Re-hospitalization
时间窗: Up to 30 days post-surgery
Number of patients re-hospitalized within 30 days of surgery
Number of Participants With Incidence of Intensive Care Unit Readmission
时间窗: Up to 24 weeks post-surgery
Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
次要结局
- Change in QOL as Measured by the LASA-12, PHQ-9, SEQ-12(Baseline up to 24 weeks after surgery)
- Expanded Complication Rate(Up to 1 year)
- Treatment Adherence Rates Related to Visits, Medication Compliance, Quitline Usage, and Surgeon Teachable Moment Delivery(Up to 12 weeks)
- Length of Hospital Stay(The time from surgery until the patient is released from the hospital)
- Change in QOL as Measured by Was It Worth It Assessments(At 24 weeks after surgery)
- Length of High Dependency Unit Stay(The time from surgery until the patient is released from the hospital)
- Smoking Abstinence Rates as Measured by Self-report(Up to 12 weeks)
- Smoking Abstinence Rates as Measured by Salivary Cotinine Testing(Up to 12 weeks)