Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Percentage of Participants who meet inclusion criteria
研究概览
简要总结
The purpose of the study is to pilot test a multi-modal smoking cessation and relapse prevention intervention with the lung cancer patient population and to obtain preliminary data on its feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •18 years of age or older
- •Smoked at least 100 cigarettes in lifetime
- •Current smoking (defined as self-report of any smoking, even a puff, in the past 30 days)
- •Diagnosis of lung cancer
- •Able to read and write English
- •Not currently enrolled in a smoking cessation program
- •Has a working telephone
- •Has a valid home address
排除标准
- •Current use of tobacco cessation medications
- •Another household member enrolled in this study
- •Contraindication of nicotine patch, unless under the supervision of a physician as advised by project staff
- •Moffitt clinical trial participant at time of enrollment
研究组 & 干预措施
Group 1: Usual Care
Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges).
干预措施: Nicotine patch and lozenges (Drug)
Group 1: Usual Care
Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges).
干预措施: Florida Tobacco Quitline (Behavioral)
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention
Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.
干预措施: Nicotine patch and lozenges (Drug)
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention
Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.
干预措施: Telephone counseling sessions (Behavioral)
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention
Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.
干预措施: Access to a web-based video (Behavioral)
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention
Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.
干预措施: Florida Tobacco Quitline (Behavioral)
结局指标
主要结局
Percentage of Participants who meet inclusion criteria
时间窗: Baseline
Percentage of participants who meet inclusion criteria
Percentage of participants completing baseline assessment
时间窗: Baseline
Percentage of participants completing baseline assessment
Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand
时间窗: at 6 months
Percentage of UC+MAPS+RP participants who viewed the web based video
Percentage of participants who agree to participate in the study
时间窗: Baseline
Percentage of participants who agree to participate in the study
Percentage of participants completing the 3 month follow-up assessments
时间窗: at 3 months
Percentage of participants completing the 3 month follow-up assessments
Completion rate of MAPS calls for UC+MAPS+RP participants - Demand
时间窗: at 6 months
Percentage of MAPS calls completed for UC+MAPS+RP participants
Treatment satisfaction - Acceptability
时间窗: at 6 months
Mean scores of the Client Satisfaction Questionnaire (SCQ-8) will be used for this measure. The CSQ-8 comprises 8 items for the assessment of treatment satisfaction using a scale from 8 to 32, with higher scores indicating greater satisfaction.
Percentage of participants completing the 6 month follow-up assessments
时间窗: at 6 months
Percentage of participants completing the 6 month follow-up assessments
Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand
时间窗: at 3 months
Percentage of UC+MAPS+RP participants who viewed the web based video
次要结局
未报告次要终点