Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Patient receipt of tobacco treatment medication for smoking cessation
研究概览
简要总结
This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco treatment in oncology patients and providers in the oncology care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This intervention may increase patient receipt of tobacco treatment, patient medication use, and patient smoking abstinence at 6 months.
详细描述
This study aims to promote the provision and use of evidence-based tobacco treatment and patient survival by integrating precision tobacco treatment into oncology care as a novel multilevel intervention. This study builds on growing evidence that 1) precision treatment may optimize treatment effectiveness by precisely matching patients with the safest, most effective medications available and 2) precision intervention may boost the implementation and effectiveness of tobacco treatment. The multilevel precision treatment intervention to be tested-PrecisionTx-- provides the opportunity to present personalized risk, benefit, and treatment recommendation to increase clinician ordering, patient uptake, and overall effectiveness of tobacco treatment.
This study aims to understand the feasibility and preliminary effects of precision treatment over usual care and associated mechanistic and implementation outcomes. Therefore, the investigators propose a 2-arm cluster randomized controlled trial of 16 clinicians and 96 patients (~6 per clinician) from oncology care settings. Clinicians and patients will be randomized with 1:1 allocation to usual care (UC) vs. precision treatment (PT) to evaluate the effect of precision treatment on patient receipt of tobacco treatment and smoking abstinence.
In Aim 1, the investigators will develop a contextually grounded multilevel PT intervention, PrecisionTx-Onc, for oncology/hematology clinics by engaging both patients and providers. In Aim 2, the investigators will conduct a 2-arm RCT to pilot the multilevel PT intervention for feasibility and determine preliminary estimates of clinical outcomes. Preliminary data will address hypotheses that the PT vs. the UC condition will produce superior physician prescribing as measured by patient receipt of prescription, patient medication use, and patient bioverified smoking abstinence at 6 months. Additional outcomes include patient quality of life and survival.
In Aim 3, the investigators will explore mechanisms of behavior change and implementation outcomes. The investigators will explore 1) mechanisms (e.g., outcome expectancies, perceived risk/benefit, and withdrawal suppression) underlying the effect of PT, and 2) implementation outcomes to evaluate its potential for scaling, using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
Primary outcomes include patient receipt of tobacco treatment, patient use of tobacco treatment, and patient smoking abstinence. Secondary outcomes include patient receipt of recommended medication, patient medication adherence, patient quality of life, patient survival, and additional patient smoking cessation outcomes. Mechanistic outcomes include clinician level (perceived benefit, outcome expectancy), clinician-patient interaction (self-efficacy), patient-level (perceived risk, outcome expectancy, withdrawal suppression, adverse events). Implementation outcomes will be evaluated based on the RE-AIM framework.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria for Clinicians:
- •Clinician from participating oncology/hematology clinic
- •At least 18 years of age
- •Can speak and understand English
- •Inclusion Criteria for Patients:
- •Patient at participating clinic
- •Age 18-89 years
- •Current smoking (average cigarettes per day ≥5)
- •Can speak and understand English
- •Willing to consider medication to help reduce craving or smoking such as nicotine patch, lozenge, or varenicline
排除标准
- •for Patients:
- •Active use of smoking cessation medication (within the past 30 days)
- •Receipt of smoking cessation medication or prescription for smoking cessation medication (within the past 30 days)
- •Having a contradiction for cNRT or varenicline (allergic reactions, current cardiac problems, pregnancy)
- •Patients who were deemed by the investigator to be ineligible for participation in the trial
研究组 & 干预措施
PrecisionTx-Onc (oncology)
Clinicians will receive PrecisionTx-Onc, an intervention designed to recommend precision tobacco treatment, adapted for oncology. Patients will receive PrecisionTx-Onc, an intervention designed to recommend precision tobacco treatment, and a brief discussion with a behavior interventionist, adapted for oncology.
干预措施: Precision treatment (Behavioral)
Usual Care
The arm will represent usual care in the oncology care clinics. Clinicians will receive a report designed to recommend guideline-based tobacco treatment. Patients will receive a report on guideline-based advice about smoking cessation and a brief discussion with a behavior interventionist.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Patient receipt of tobacco treatment medication for smoking cessation
时间窗: 6 months post-intervention
This will be quantified by the proportion of enrolled patients who receive cessation medication.
Patient use of cessation medication
时间窗: 6 months post-intervention
This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.
Patient smoking abstinence
时间窗: 6 months post-intervention
This will be quantified by the proportion of patients who smoke with bioverified point-prevalent abstinence at 6 months.
次要结局
- Patient medication adherence(6 months post-intervention)
- Patient smoking abstinence among treated(6 months post-intervention)
- Abstinence Outcomes Across Multiple Time Points(From intervention through 12 months post-intervention)
- Smoking quantity across multiple time points(From intervention through 12 months post-intervention)
- Quit attempts(6 and 12 months post-intervention)
- Patient quality of life(6 and 12 months post-intervention)
- Patient quality of life(6 and 12 months post-intervention)
- Patient survival(6 and 12 months post-intervention)
- Patient medication adherence(6 months post-intervention)
- Smoking quantity across multiple time points(From intervention through 12 months post-intervention)
- Patient receipt of recommended tobacco treatment(6 months post-intervention)
- Quit attempts(6 and 12 months post-intervention)
- Patient smoking abstinence among treated(6 months post-intervention)
- Abstinence Outcomes Across Multiple Time Points(From intervention through 12 months post-intervention)