PRecision Interventions for SMoking in the SCCS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Developing Precision Smoking Treatment in the Southern Community Cohort Study

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Drug: Nicotine patch
* Drug: Varenicline
* Genetic: Nicotine metabolism
* Genetic: Genetically-informed lung cancer risk score
* Behavioral: NCI Clearing the Air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assessing parallel precision care interventions (groups 1, 2) and control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Guideline-Based Care (GBC)<br>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. | Drug: Nicotine patch<br>* FDA-approved smoking cessation pharmacotherapy<br>* Other names: Nicotine Replacement Therapy;Drug: Varenicline<br>* FDA-approved smoking cessation pharmacotherapy<br>* Other names: Chantix;Behavioral: NCI Clearing the Air<br>* A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.<br>|
| Active Comparator: Nicotine Metabolite Ratio (PC-NMR)<br>Group 1, nicotine metabolism. Medication is guided by nicotine metabolism. | Drug: Nicotine patch<br>* FDA-approved smoking cessation pharmacotherapy<br>* Other names: Nicotine Replacement Therapy;Drug: Varenicline<br>* FDA-approved smoking cessation pharmacotherapy<br>* Other names: Chantix;Genetic: Nicotine metabolism<br>* Information on nicotine metabolism will be used to inform selection of medication.<br>Behavioral: NCI Clearing the Air<br>* A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.<br>|
| Active Comparator: Respiragene (PC-Respiragene)<br>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. | Drug: Nicotine patch<br>* FDA-approved smoking cessation pharmacotherapy<br>* Other names: Nicotine Replacement Therapy;Drug: Varenicline<br>* FDA-approved smoking cessation pharmacotherapy<br>* Other names: Chantix;Genetic: Genetically-informed lung cancer risk score<br>* This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.<br>Behavioral: NCI Clearing the Air<br>* A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Feasibility: Ability to Retain Participants | 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. | Full trial: Baseline - 6 month survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation History - Quit Attempts | Participants who reported making a quit attempt during the trial, as defined by use of a quit aid or reporting not at all for current smoking at any timepoint | Full trial: Baseline - 6 month survey | 
| Cessation History - Medication Use | Participants who received, and those who subsequently used, a smoking cessation medication during the trial | Full trial: Baseline - 6 month survey | 
| Cessation History - Quitline | Participants who reported using the quitline (phone support) at any point during the trial | Full trial: Baseline - 6 month survey | 
| Cessation History - Self-reported Abstinence | Participants who self-reported abstinence at the 6 month survey | 6 months | 
| Cessation History - Validated Abstinence | Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco Use Cessation, Precision Medicine