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临床试验/NCT00580398
NCT00580398已完成1 期

A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
49
试验地点
1
主要终点
Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Intervention

Experimental

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.

干预措施: Smoking cessation counseling (Behavioral)

Intervention

Experimental

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.

干预措施: varenicline (Drug)

结局指标

主要结局

Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.

时间窗: 12 weeks

Number of participants who completed the 12-week follow-up survey and thus the study.

次要结局

  • Biochemically-validated 7-day Point Prevalence Tobacco Abstinence(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elyse Park, PhD

Elyse Park, PhD, Principal Investigator

Massachusetts General Hospital

研究点 (1)

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