Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants With Confirmed Smoking Abstinence
研究概览
简要总结
This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years and older
- •Cancer survivors (based on the NCI definition - "a person is considered to be a survivor from the time of diagnosis until the end of life" National Cancer Institute Dictionary of Cancer Terms, 2014)
- •Cancer patients currently in active treatment
- •Have smoked ≥ 5 cigarettes/day in the past year
- •Be interested in making a quit attempt in the next 30 days
- •Own a smartphone (apple/android)
- •Read/speak English
- •Able to consent
- •Have no plans to move in the next 3 months
- •Are not pregnant or planning to be pregnant in the following 3 months
排除标准
- •Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
- •Are currently being treated for a psychiatric condition
- •Are currently being treated for smoking cessation, alcoholism, or illicit drug use
- •Are adults unable to consent
- •Are individuals who are not yet adults
- •Are pregnant women
- •Are prisoners
研究组 & 干预措施
Usual Care
Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking.
干预措施: Nicoderm C-Q Transdermal Product (Drug)
Usual Care
Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking.
干预措施: Brief advice on quitting smoking (Behavioral)
Usual Care
Participants in this group will receive a brief advice to quit smoking, 6-week supplies of nicotine replacement therapy (NRT), and self-help materials to quit smoking.
干预措施: Self-help smoking cessation materials (Behavioral)
Craving-to-Quit app
Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls.
干预措施: Nicoderm C-Q Transdermal Product (Drug)
Craving-to-Quit app
Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls.
干预措施: Orientation session (Behavioral)
Craving-to-Quit app
Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls.
干预措施: Craving-to-Quit app (Behavioral)
Craving-to-Quit app
Participants in this group will receive one "in-person" or online orientation session, 6-week supply of NRT, the "Craving-to-Quit" app, and two brief follow-up phone calls.
干预措施: Two brief follow-up phone calls (Behavioral)
Group Mindfulness Training
Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT).
干预措施: Nicoderm C-Q Transdermal Product (Drug)
Group Mindfulness Training
Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT).
干预措施: Orientation session (Behavioral)
Group Mindfulness Training
Participants in this group will receive twice weekly group sessions (eight total during 4 weeks) that were manualized and delivered by instructors experienced in Mindfulness Training (MT) (a single therapist with >4 years of training in MT).
干预措施: Group MT sessions (Behavioral)
结局指标
主要结局
Number of Participants With Confirmed Smoking Abstinence
时间窗: 3 months
Number of participants who self-report of not smoking in the past 7-days, not even a puff, confirmed by expired carbon monoxide (CO) level of \< 10 ng/ml.
次要结局
- Change in Number of Cigarettes Smoked Per Day(Baseline, 3 months)
- Usability of the Craving-to-Quit App as Assessed by the Number of Days of Completed App Use(3 months)
- Usability of the Craving-to-Quit App as Assessed by the Comfortability With the App(3 months)
- Feasibility of Recruitment as Assessed Via Enrollment Rate(Baseline)
- Number of Participants With Reported Relapse(3 months)
- Usability of the Craving-to-Quit App(3 months)
- Acceptability(3 months)
- Attrition(3 months)
研究者
Taghrid Asfar
Research Assistant Professor
University of Miami