Preventing Lung Cancer Through Tobacco Cessation at FDNY
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Enrollment
研究概览
简要总结
At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.
详细描述
The overarching goal of this Randomized Controlled trial is to develop and test an effective, scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer screening who have not engaged in or succeeded with traditional tobacco treatment approaches. The investigators will test an Enhanced Care intervention specifically designed to address multiple challenges to tobacco treatment engagement and success. First, the researchers will test opt-out enrollment in cessation treatment. The current tobacco treatment default, in which patients must opt-in to cessation treatment and are only offered counseling and pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an opt-out tobacco treatment strategy substantially increases engagement and cessation rates compared with traditional opt-in approaches. Second, proactive counseling will leverage the "reachable, teachable moment" of CT screening to motivate cessation through individually tailored messaging tied to CT results and lung function spirometry. Using CT results as a motivational tool has shown promise in pilot studies. The optimal approach and success of using CT coupled with spirometry results to motivate tobacco cessation remains unknown. Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is associated with decreased pre-quit tobacco-associated reward and double the rate of abstinence compared with standard varenicline treatment.
The investigators thus propose a randomized trial among retired FDNY World Trade Center Health Program responders eligible for the FDNY World Trade Center Health Program CT screening program to test the effects of Enhanced Care (opt-out enrollment, tailored counseling based on CT and spirometry results, and varenicline with preloading) against Standard Care (opt-in enrollment, standard cessation counseling without spirometry/CT tailoring, and varenicline with preloading) in the engagement of high-risk smokers in cessation treatment and the achievement of tobacco abstinence.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in FDNY World Trade Center Health Program (WTCHP)
- •Age ≥ 50 years old
- •Self-reported current smoker on most recent questionnaire OR self-reported current smoker in the past 5 years
- •20 pack-year smoker OR 20-year smoking duration
排除标准
- •Reduced renal function
- •estimated glomerular filtration rate (eGFR) <30 [CKD-EPI Creatinine Equation (2021)] at last World Trade Center (WTC) medical monitoring blood exam OR ICD10 codes for kidney disease: N04.9, N17.9, N18.9, Z94.0, E13.21, N18.9, I12.9, N00.9, N03.9
- •Undergoing active cancer treatment, defined as being diagnosed on 1/1/2022 or later
- •Clinical instability (e.g., hospitalization in last 3 months)
- •Using varenicline in last 30 days
- •Endorsing suicidal ideations: moderate or high risk on Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Screened for alcohol use disorder AUDIT>15
研究组 & 干预措施
Standard Care
Opt-in counseling enrollment. Standard tobacco cessation counseling.
Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.
1 mg twice day for 12 weeks after target quit date.
干预措施: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date (Other)
Enhanced Care
Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results.
Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.
1 mg twice day for 12 weeks after target quit date.
干预措施: opt out enrollment, tailored counseling, varenicline started prior to target quit date (Other)
结局指标
主要结局
Enrollment
时间窗: Baseline (Week 0)
Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms. The number of participants who attend the first visit with the tobacco treatment specialist will be tabulated and reported.
Tobacco Abstinence
时间窗: From baseline (Week 0) through each research assessment visit up to the 12-week post EOT timepoint visit at 28 weeks
7-day point prevalence abstinence will be biochemically verified by the analysis of urine samples collected at a laboratory nearest each participant's residence. Urine samples collection will occur at baseline, and at weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint at 28 weeks. Samples will be analyzed for urine cotinine which is the commonly measured biomarker of nicotine intake. Urine cotinine levels \< 20 ng/mL will be used to verify tobacco abstinence. Data will be summarized at each timepoint by study arm using basic descriptive statistics at each research assessment visit.
次要结局
- Retention to Study End-Date(Through the 12-week post EOT timepoint at 28 weeks)
- Counseling adherence(From baseline (Week 0) through each visit up to the 12-week post EOT timepoint visit at 28 weeks)
- Tobacco Abstinence(From baseline (Week 0) through each research assessment visit up to the 12-week post EOT timepoint visit at 28 weeks)
- Varenicline (pill count) adherence(Up through the time of the final research visit at Week 16)