Smoking Cessation Intervention for Thoracic Patients
2018年9月13日 更新者:Elyse Park, PhD、Massachusetts General Hospital
A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients
The primary aim of the proposed study is to develop and assess the feasibility of delivering a smoking cessation intervention to patients undergoing lung surgery that begins before surgery and continues up to 3 months post-discharge.
The secondary aim is to assess smoking cessation rates 3 months following surgery.
研究概览
详细说明
This is a pilot study evaluating the feasibility of a cognitive-behavioral smoking cessation plus Varenicline program, designed specifically for early stage lung cancer patients and patients with a potential lung cancer diagnosis pre and post-surgery.
The study population will be approximately 80 smokers who have upcoming lung resection surgery scheduled at Massachusetts General Hospital (MGH) in Boston.
A patient will be considered eligible for the intervention or control group if he or she 1) is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis, and 2) had a cigarette in the past 2 weeks, 3) is willing to make a pre-surgical quit attempt.
Patients will be excluded from the control group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon/oncologist, 3) suffering from psychosis or dementia 4) is currently on Varenicline has been on Varenicline for more than 3 weeks, or 5) is otherwise unable to participate in the intervention.
Patients will be excluded from the intervention group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon, 3) suffering from psychosis or dementia 4) have been taking Varenicline for longer than three weeks 5) have been taking Bupropion (for smoking cessation purposes) for more than three weeks, 6) is otherwise unable to participate in the intervention.
研究类型
介入性
注册 (实际的)
49
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
A patient is eligible if he/she:
- Is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis
- Smoked a cigarette in the past 2 weeks
- Is willing to make a pre-surgical quit attempt
Exclusion Criteria:
Patients will be excluded from the intervention group if they are:
- Non-English speaking
- Determined medically ineligible by their surgeon
- Suffering from psychosis or dementia
- Have been taking Varenicline for longer than three weeks
- Have been taking Bupropion (for smoking cessation purposes) for more than three weeks
- Is otherwise unable to participate in the intervention.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:Control
Usual care included physician advice to quit smoking.
|
|
|
实验性的:Intervention
Intervention participants were provided with a cognitive-behavioral 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients.
We offered 7 counseling sessions but were flexible in offering additional counseling when needed.
Counseling was delivered by a certified Tobacco Treatment Counselor using Motivational Interviewing (MI) techniques.
|
Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.
其他名称:
varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
大体时间:12 weeks
|
Number of participants who completed the 12-week follow-up survey and thus the study.
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biochemically-validated 7-day Point Prevalence Tobacco Abstinence
大体时间:12 weeks
|
7-day point prevalence abstinence ("Have you smoked a cigarette, even a puff, in the past 7 days?")
was assessed at 12-week follow-up.
Self reported abstinence was confirmed only if a salivary cotinine level was < 15 ng/ml or an expired carbon monoxide measurement was <10 ppm.
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Elyse Park, Ph.D.、MGH
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年1月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2007年12月20日
首先提交符合 QC 标准的
2007年12月21日
首次发布 (估计)
2007年12月24日
研究记录更新
最后更新发布 (实际的)
2018年10月12日
上次提交的符合 QC 标准的更新
2018年9月13日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.