Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Smoking cessation
研究概览
简要总结
Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and neck) and negatively impacts survival and other outcomes, but many patients have difficulty quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far have had limited success. This is a pilot randomized controlled trial designed to determine if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates for cancer patients who smoke.
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
- None
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of head and neck or thoracic (including lung) cancer
- •Undergoing radiation at Johns Hopkins Radiation Oncology for 5 or more weeks
- •English-speaking and able to provide informed consent
- •Smoked any cigarettes in previous 14 days
排除标准
- •Palliative radiation
- •Undergoing stereotactic radiosurgery
- •Pregnant or breastfeeding
研究组 & 干预措施
Comprehensive intervention
New evidence-based comprehensive smoking cessation intervention including several elements that have proven successful in non-cancer patients but not used for cancer patients before.
干预措施: Comprehensive smoking cessation intervention (Other)
Enhanced usual care
Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.
干预措施: Enhanced usual care (Behavioral)
结局指标
主要结局
Smoking cessation
时间窗: 8 weeks
Smoking cessation will be defined as BOTH (1) self-reported 7-day abstinence from smoking and (2) exhaled carbon monoxide level of 8 or lower as biochemical confirmation of abstinence.
次要结局
未报告次要终点