Smoking Cessation and Alcohol Use Among Cancer Survivors: Investigating the Efficacy of a Mindfulness-Based Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence
研究概览
简要总结
This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.
详细描述
The primary aim of this study is to test the efficacy of MBRP-SA compared with standard care among cancer survivors, explore potential moderators, mechanisms, and predictors of treatment effects, and evaluate implementation outcomes to guide future adoption of MBRP-SA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years old
- •History of a cancer diagnosis at any point in lifetime
- •Smoked ≥1 cigarette/day in past month
- •At least one binge drinking episode in past month or exceeds weekly drinking limits
- •Motivated to quit smoking and modify alcohol use in next 30 days
- •Valid home address in Florida
- •English-speaking, reading, and writing ability
排除标准
- •Pregnancy or lactation
- •Active psychotic disorder
- •History of severe alcohol withdrawal
- •Current use of tobacco cessation medication or other treatments to quit smoking
- •End-of-life or hospice care
- •Household member already enrolled
研究组 & 干预措施
Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)
Participants randomized to this condition will receive a mindfulness-based intervention delivered in a group format via Zoom.
干预措施: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) (Behavioral)
Quitline Support
Participants randomized to this condition will be connected to the Florida Tobacco Quitline for smoking cessation services, as well as receive community referrals for alcohol use treatment.
干预措施: Quitline Support (Behavioral)
结局指标
主要结局
Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence
时间窗: 6 months post treatment
Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine \<10 ng/mL.
Percent Heavy Drinking Days (Past 4 Weeks)
时间窗: 6 months post treatment
Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women)
次要结局
未报告次要终点