Smoking Cessation Intervention (Including Bupropion-Zyban Versus Placebo) for Completely Resected Stage I and II Non-Small Cell Lung Cancer Survivors Who Are Current Smokers
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 176
- 主要终点
- To compare the effect on 12 month quit rates of adding an anti-depressant versus placebo in a double blind to an intervention and nicotine replacement in complete resected Stage I and II non-small cell lung cancer patients who are current smokers
研究概览
简要总结
RATIONALE: A program that includes bupropion may be more effective in helping early-stage lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is more effective with or without bupropion.
PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit smoking with or without bupropion in treating patients who have undergone surgery for stage I or stage II non-small cell lung cancer.
详细描述
OBJECTIVES:
- Compare the effect of a smoking cessation intervention comprising behavior intervention and nicotine replacement with or without bupropion on 12-month quit rates in patients with completely resected stage I or II non-small cell lung cancer who are current smokers.
- Compare the predictors of smoking cessation success in patients treated with these regimens.
- Determine the relationship between smoking cessation and standard outcome measures (e.g., second malignancies, survival, and symptom status) in patients treated with these regimens.
- Compare the effect of these treatment regimens on emotional functioning in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to gender, prior neoadjuvant or concurrent adjuvant chemotherapy and/or radiotherapy (yes vs no), and time since prior surgery (less than 6 months vs 6 to 12 months vs more than 12 months). Patients are randomized to 1 of 2 arms.
All patients receive behavioral intervention comprising smoking cessation advice and education on day 1. Patients quit smoking on day 8. Patients then receive a nicotine transdermal patch once daily on days 8-77.
- Arm I: Patients receive oral bupropion once daily on days 1-3 and twice daily on days 4-77.
- Arm II: Patients receive oral placebo as in arm I. Patients are followed at 3, 6, and 12 months and then annually for 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Behavioral Intervention + Placebo
Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.
干预措施: smoking cessation intervention (Behavioral)
Behavioral Intervention + Placebo
Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.
干预措施: nicotine (Drug)
Behavioral Intervention + Placebo
Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.
干预措施: psychosocial assessment and care (Procedure)
Behavioral Intervention + Bupropion
Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .
干预措施: smoking cessation intervention (Behavioral)
Behavioral Intervention + Bupropion
Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .
干预措施: bupropion hydrochloride (Drug)
Behavioral Intervention + Bupropion
Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .
干预措施: nicotine (Drug)
Behavioral Intervention + Bupropion
Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .
干预措施: psychosocial assessment and care (Procedure)
结局指标
主要结局
To compare the effect on 12 month quit rates of adding an anti-depressant versus placebo in a double blind to an intervention and nicotine replacement in complete resected Stage I and II non-small cell lung cancer patients who are current smokers
时间窗: 12 months
次要结局
- To assess predictors of successful cessation in male and female patients.(12 months)
- To explore the relationship between smoking cessation and standard outcome measures.(12 months)
- To compare the effect on emotional functioning of adding bupropion to a behavioral intervention plus nicotine replacement in this patient population.(12 months)