Developing Precision Smoking Treatment in the Southern Community Cohort Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Intervention Feasibility: Ability to Retain Participants
研究概览
简要总结
Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who reside in TN or MS. Participants will be randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer risk score, and (3) group 3 is Guideline-Based Care (GBC). All groups will be followed for 6 months. All RCT participants will receive FDA-approved smoking cessation medication, be referred to the shared TN/MS state quitline, and be offered the NCI "Clearing the Air" standard intervention. The primary outcome is feasibility of delivering the precision interventions in the SCCS population, as evidenced by ability to recruit, engage, and retain participants through end of study. Secondary outcomes, for which the study is not powered, will include risk perceptions, use of quit aids, lung cancer screening among those who are eligible, and smoking cessation.
详细描述
Cigarette smoking significantly increases the risk of cancer and improved cessation strategies are needed. Biologically-informed precision treatment could benefit smokers but is understudied.
Tennessee and Mississippi Smokers that responded to a previous survey indicating willingness to be contacted for a smoking cessation clinical trial will be assessed for eligibility via phone and, if eligible, provide verbal consent and administer a baseline survey. These participants will then mail in written consent, upon receipt of which their SCCS stored blood samples will be analyzed. During lab processing, a study tobacco counselor will call enrolled participants to assist with their quit plan and inform them of randomization status. Participants will complete telephone surveys at 1, 3, and 6 months. During the 6 month follow-up call, participants will also be given their previously-unreported lab results (i.e., information on nicotine metabolism or lung cancer risk). After receiving lab results, participants will complete a final brief questionnaire.
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
- Single (Outcomes Assessor)
盲法说明
Assessors will be blind to participant arm assignment until delivery of lab results at month 6.
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
- •Daily smoker of ≥5 cigarettes per day (CPD)
- •Enrolled participant of the Southern Community Cohort Study (SCCS) who completed a prior survey indicating they were willing to be contacted regarding a smoking cessation clinical trial
- •Residence in Tennessee (TN) or Mississippi (MS)
- •Has stored blood sample with the SCCS
- •Has established primary care provider (PCP)
- •Medically eligible and willing to take varenicline and NRT
排除标准
- •Currently taking medication to quit smoking
- •enrolled, or planning to be enrolled, in another smoking cessation program
- •Inability to give informed consent or participate due to cognitive disorder (e.g., dementia, severe intellectual disability)
- •Unstable psychiatric illness (ER or hospitalized for psychiatric condition in past 6 months, change in psychiatric medications in past 3 months, or suicidal ideation in past 6 months)
- •not able to send or receive mail
- •no access to a telephone or inability to communicate by telephone
- •unable to speak and read English
- •history of seizures or Buerger's disease
- •currently pregnant or breastfeeding
研究组 & 干预措施
Nicotine Metabolite Ratio (PC-NMR)
Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
干预措施: NCI "Clearing the Air" (Behavioral)
Guideline-Based Care (GBC)
GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.
干预措施: Nicotine patch (Drug)
Guideline-Based Care (GBC)
GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.
干预措施: Varenicline (Drug)
Guideline-Based Care (GBC)
GBC participants are 1) referred to the state quitline, 2) provided the NCI Clearing the Air smoking cessation program, and 3) asked to talk to their healthcare provider about potential lung cancer screening (LCS). Medication assignment is guided by standard guidelines and a conversation between the study tobacco counselor and the participant. Groups 1 and 2 also receive GBC counseling.
干预措施: NCI "Clearing the Air" (Behavioral)
Nicotine Metabolite Ratio (PC-NMR)
Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
干预措施: Nicotine patch (Drug)
Nicotine Metabolite Ratio (PC-NMR)
Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
干预措施: Varenicline (Drug)
Nicotine Metabolite Ratio (PC-NMR)
Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.
干预措施: Nicotine metabolism (Genetic)
Respiragene (PC-Respiragene)
Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.
干预措施: Nicotine patch (Drug)
Respiragene (PC-Respiragene)
Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.
干预措施: Varenicline (Drug)
Respiragene (PC-Respiragene)
Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.
干预措施: Genetically-informed lung cancer risk score (Genetic)
Respiragene (PC-Respiragene)
Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.
干预措施: NCI "Clearing the Air" (Behavioral)
结局指标
主要结局
Intervention Feasibility: Ability to Retain Participants
时间窗: Full trial: Baseline - 6 month survey
Feasibility of delivering precision care (PC) interventions in the Southern Community Cohort Study (SCCS), as evidenced by ability to recruit, engage, and retain participants through end of the study.
次要结局
- Cessation History - Self-reported Abstinence(6 months)
- Cessation History - Validated Abstinence(6 months)
- Cessation History - Medication Use(Full trial: Baseline - 6 month survey)
- Cessation History - Quitline(Full trial: Baseline - 6 month survey)
- Cessation History - Quit Attempts(Full trial: Baseline - 6 month survey)
研究者
Hilary Tindle
Associate Professor of Medicine
Vanderbilt University Medical Center