Optimization of Smoking Cessation Strategies Concurrent With Treatment of Tobacco Related Malignancies
2020年1月27日 更新者：Joseph Valentino、University of Kentucky
The purpose of this study is to find an optimal smoking cessation strategy in patients undergoing therapy for lung and head and neck cancers at selected cancer centers in Kentucky by delivering high quality smoking cessation to all enrolled patients.
This study will also examine the feasibility of routinely implementing an array of smoking cessation strategies for this patient population.
研究概览
地位
完全的
干预/治疗
- 药品：High Intensity Counseling + Long Acting NRT + PRN NRT
- 药品：High Intensity Counseling + bupropion + PRN NRT
- 药品：High Intensity Counseling + varenicline + PRN NRT
- 药品：High Intensity Counseling + Long Acting NRT
- 药品：High Intensity Counseling + bupropion
- 药品：High Intensity Counseling + varenicline
- 药品：Low Intensity Counseling + Long Acting NRT + PRN NRT
- 药品：Low Intensity Counseling + bupropion + PRN NRT
- 药品：Low Intensity Counseling + varenicline + PRN NRT
- 药品：Low Intensity Counseling + Long Acting NRT
- 药品：Low Intensity Counseling + bupropion
- 药品：Low Intensity Counseling + varenicline
详细说明
Subjects enrolled in the study will be placed in one of twelve treatment arms.
Subjects in each of the twelve treatment regimens will receive either varenicline or bupropion or long-acting nicotine replacement therapy, with or without use of supplemental nicotine replacement therapy, and in combination with either standard of care smoking cessation counseling or high intensity/motivational smoking cessation counseling.
研究类型
介入性
注册 (实际的)
93
阶段
- 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
-
-
Kentucky
-
Ashland、Kentucky、美国、41101
- King's Daughters Medical Center
-
Elizabethtown、Kentucky、美国、42701
- Hardin Memorial Health Cancer Care Center
-
Hazard、Kentucky、美国、41701
- Kentucky Cancer Clinic
-
Hazard、Kentucky、美国、41701
- ARH Cancer Center
-
Lexington、Kentucky、美国、40536
- University of Kentucky, Markey Cancer Center
-
Lexington、Kentucky、美国、40502
- Lexington Veterans Affair Medical Center
-
Louisville、Kentucky、美国、40202
- University of Louisville, James Graham Brown Cancer Center
-
Morehead、Kentucky、美国、40351
- St. Claire Regional Medical Center
-
Owensboro、Kentucky、美国、42303
- Owensboro Health
-
-
West Virginia
-
Huntington、West Virginia、美国、25702
- St. Mary's Medical Center
-
-
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
18年 及以上 (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:
- Patients must be ≥ 18 years of age.
Patient with newly diagnosed or recurrent, histologic diagnosis of any of the following tobacco related malignancies:
- Lung or Bronchus cancer or Head & Neck, cancers (all sites).
- Esophagus, Stomach, Pancreas, Kidney, Urinary Bladder, Colon, Rectum, Cervix, Vulvar, Vaginal
- Carcinoma in situ undergoing definitive surgical resection or treatment (ex: radiation of the larynx, and gynecologic tract hysterectomy, vulvectomy - except gynecologic patients undergoing ablative or local excisional therapies [laser ablation,cervical conization, LEEP].
- Having smoked at least 1 cigarette within 4 weeks of study enrollment.
- Having at least a 10-pack year history of cigarette smoking.
- Having smoked at least one cigarette within 1 month of cancer diagnosis.
- Life expectancy is greater than 1 year.
- Patient has an AUDIT score of < 10.
- Patient has ECOG Performance Status of <=2.
- Patients must have the ability to understand and the willingness to provide signed written informed consent document.
Exclusion Criteria:
- Known allergy attributed to bupropion, varenicline, transdermal or lozenge nicotine.
- History of suicide attempt or preparation for attempt within the past 10 years.
C-SRSS Baseline/Screening:
- Patient response of "Yes" to any question except question 1.
- Patient response of "Yes" to any question in column one (lifetime), except question 1, is not exclusionary unless judged by the investigator to be significant in ideation, intensity, behavior or attempts, and precludes participation.
- Hospitalized for psychiatric illness within the past two years.
- History of Bipolar disorder.
- Currently taking Bupropion for depression.
- Patient has taken monoamine oxidase inhibitors (MAOI) in the past two weeks.
- History of eating disorder such as anorexia or bulimia.
- Active widespread skin disorders such as psoriasis, chronic urticarial or dermatitis
- History of epilepsy or seizure disorder.
- Active severe kidney or liver disease.
- Women must not be pregnant or lactating. Women of reproductive-potential must have negative serum or urine pregnancy test within 7 days prior to study enrollment and agree to use method of contraception during and for 30 days following last cessation drug dose.
- Patients within three months of a myocardial infarction.
- Patients with unstable angina or serious arrhythmia.
- Patients with psychiatric disability judged by the investigator to be clinically significant so as to preclude informed consent or compliance with drug intake.
- Patient taking varenicline or bupropion within one month of study enrollment.
- Participation in any other investigational drug study within 4 weeks of study enrollment.
- Currently enrolled in other professional tobacco cessation therapeutic intervention.
- Enrollment in a concurrent cancer therapeutic trial will require prior review and approval by the study site PI to determine that there are no drug interactions concerns.
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：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 |
|---|---|
|
实验性的：High Intensity Counseling + Long Acting NRT + PRN NRT
|
High Intensity Counseling + Long Acting NRT + PRN NRT
|
|
实验性的：High Intensity Counseling + bupropion + PRN NRT
|
High Intensity Counseling + bupropion + PRN NRT
|
|
实验性的：High Intensity Counseling + varenicline + PRN NRT
|
High Intensity Counseling + varenicline + PRN NRT
|
|
实验性的：High Intensity Counseling + Long Acting NRT
|
High Intensity Counseling + Long Acting NRT
|
|
实验性的：High Intensity Counseling + bupropion
|
High Intensity Counseling + bupropion
|
|
实验性的：High Intensity Counseling + varenicline
|
High Intensity Counseling + varenicline
|
|
实验性的：Low Intensity Counseling + Long Acting NRT + PRN NRT
|
Low Intensity Counseling + Long Acting NRT + PRN NRT
|
|
实验性的：Low Intensity Counseling + bupropion + PRN NRT
|
Low Intensity Counseling + bupropion + PRN NRT
|
|
实验性的：Low Intensity Counseling + varenicline + PRN NRT
|
Low Intensity Counseling + varenicline + PRN NRT
|
|
实验性的：Low Intensity Counseling + Long Acting NRT
|
Low Intensity Counseling + Long Acting NRT
|
|
实验性的：Low Intensity Counseling + bupropion
|
Low Intensity Counseling + bupropion
|
|
实验性的：Low Intensity Counseling + varenicline
|
Low Intensity Counseling + varenicline
|
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 |
|---|---|---|
|
Cigarette use
大体时间：8 weeks
|
Seven day point prevalence of cigarette use confirmed with CO testing at eight weeks.
|
8 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：Joseph Valentino, M.D.、University of Kentucky
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 (实际的)
2014年7月22日
初级完成 (实际的)
2019年5月15日
研究完成 (实际的)
2019年5月15日
研究注册日期
首次提交
2014年1月27日
首先提交符合 QC 标准的
2014年1月27日
首次发布 (估计)
2014年1月29日
研究记录更新
最后更新发布 (实际的)
2020年1月29日
上次提交的符合 QC 标准的更新
2020年1月27日
最后验证
2020年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MCC-13-MULTI-13-KCTN-1301
- KCTN-1301 (其他标识符：Markey Cancer Center)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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.