Comparative Effectiveness Trial of Tobacco Cessation Treatments Among Cancer Patients Who Smoke
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date.
研究概览
简要总结
This pilot comparative effectiveness trial will compare two active smoking cessation treatments in terms of effectiveness, equity across patient subpopulations, and efficiency among adult patients diagnosed with cancer within the past 3 years. An enhanced treatment comprising 12 weeks of varenicline treatment and 7 smoking cessation coaching calls with a cancer focus will be compared against an active comparator modeled after standard quitline treatments (2 weeks of nicotine patch therapy with 3 phone coaching calls). Approximately 50 participants will be recruited to generate estimates of the effects, acceptability, costs, and equity of enhanced treatment (vs. standard treatment), with the primary outcome being abstinence from smoking 26 weeks after trying to quit.
详细描述
Primary Aim
1. To generate estimates of the size of the comparative effects of enhanced, cancer-specific smoking cessation treatment versus a generic standard care package similar to quitline care in terms of biochemically confirmed 7-day point prevalence abstinence (no smoking in the past 7 days) 26 weeks after a target quit date.
Exploratory Aims
- To estimate differences in CET arms in exploratory outcomes including patient acceptability, completion, adherence, costs, and cost-effectiveness.
- To estimate the extent to which treatment effects on abstinence and exploratory outcomes differ across patient subpopulations based on demographics (age, race, sex, ethnicity, socioeconomic disadvantage); nicotine dependence; and cancer site, stage, and treatment phase.
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
- •Alive (per medical record)
- •Diagnosed with cancer in the past 3 years
- •Received care from a participating oncology clinic in the past year
- •Has a current tobacco use status
- •Does not have a preferred language other than English (missing language preference will be included).
- •Valid address that is not a correctional facility or residential treatment/care facility.
- •No flag for patient cognitive impairment, activated health care power of attorney, or other health care agent (e.g., legally authorized representative) in the EHR.
- •The following additional inclusion criteria must be met for inclusion in the CET
- •Smoked combustible cigarettes in the past month.
- •Able to speak and understand English.
- •Willing to set a date to quit smoking in the next 60 days.
- •Willing to receive smoking treatment information.
- •Willing to complete study activities.
排除标准
- •No current suicidal ideation.
- •Suicide attempt in the past year.
- •Currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder.
- •Incarceration.
- •Unable to provide informed consent to treatment (i.e., cannot answer questions about study procedures or risks after hearing about the study).
研究组 & 干预措施
Low-Intensity Standard Smoking Cessation Treatment
2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)
干预措施: Transdermal Nicotine Patch (Drug)
Low-Intensity Standard Smoking Cessation Treatment
2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)
干预措施: Standard Telephone Counseling (Behavioral)
Low-Intensity Standard Smoking Cessation Treatment
2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)
干预措施: Mailed Information about Standard Care Resources (Other)
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
干预措施: Varenicline (Drug)
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
干预措施: Cancer-Targeted Telephone Counseling (Behavioral)
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
干预措施: Mailed Information about Standard Care Resources (Other)
结局指标
主要结局
Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date.
时间窗: up to 30 weeks post target quit date
This measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test.
次要结局
- Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date.(up to 13 weeks post target quit date)