Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pre Surgery Smoking Abstinence
研究概览
简要总结
The purpose of this clinical trial is to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery.
详细描述
The investigators are proposing a developmental interdisciplinary pilot study to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery. This study (a follow up to smaller pilot studies) will serve as a means to further develop a treatment protocol and to generate an accurate effect size for a full scale trial. The present study will constitute a development clinical trial with a primary aim of developing an effect size for smoking cessation at the time of surgery (7-day point prevalence abstinence), and a secondary aim of creating an effect size for long-term abstinence at 3 months post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (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
- •age 18 or older
- •smoking ≥ 1 cigarettes per day
- •CO > 6 ppm
- •diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer
- •agreement on a 2-5-week pre-surgical tobacco intervention by both patient and surgeon, and 6) residence within reasonable driving distance to New Haven.
排除标准
- •unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
- •unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
- •pregnant or breastfeeding women
- •those with limited decision making capacity.
研究组 & 干预措施
Standard Care (SC)
Patients in the SC arm will receive 4 counseling sessions and nicotine patches as part of typical cessation measures delivered to patients.
干预措施: Standard of Care (SC) (Behavioral)
Contingency Management (CM)
Patients in the CM arm will receive monetary payment contingent on smoking abstinence (in addition to SC: 4 counseling sessions and nicotine patches).
干预措施: Contingency Management (CM) (Behavioral)
Contingency Management (CM)
Patients in the CM arm will receive monetary payment contingent on smoking abstinence (in addition to SC: 4 counseling sessions and nicotine patches).
干预措施: Standard of Care (SC) (Behavioral)
结局指标
主要结局
Pre Surgery Smoking Abstinence
时间窗: Day of Surgery
Participants will be classified as succeeded or failed in cessation based on a definition of 1 week of abstinence from cigarettes leading up to the day of their surgery based on self-report and confirmed with biochemical verification (CO≤6ppm). For participants who are classified as abstinent, a chi-square will be computed comparing whether treatment with CM is superior to SC in producing a higher probability of abstinence. These data will be used to compute an effect size, Cohen's w, for smoking cessation.
次要结局
- Post Surgery Smoking Abstinence(3 months)