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| ID | Type | Description | Link |
|---|---|---|---|
| 16-06-571 | Other Identifier | Meharry Medical College | |
| HS2016-3815 | Other Identifier | Tennessee State University |
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| Name | Class |
|---|---|
| Meharry Medical College | OTHER |
| Tennessee State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guideline-Based Care (GBC) | Other | 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. |
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| Nicotine Metabolite Ratio (PC-NMR) | Active Comparator | Group 1, nicotine metabolism. Medication is guided by nicotine metabolism. |
|
| Respiragene (PC-Respiragene) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | FDA-approved smoking cessation pharmacotherapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary A Tindle, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Maureen Sanderson, PhD, RD, MPH | Meharry Medical College | Principal Investigator |
| Rebecca Selove, PhD, MPH | Tennessee State University | Principal Investigator |
| William Blot, PhD | Southern Community Cohort Study, Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38491559 | Derived | Lee SS, Senft Everson N, Sanderson M, Selove R, Blot WJ, King S, Gilliam K, Kundu S, Steinwandel M, Sternlieb SJ, Cai Q, Warren Andersen S, Friedman DL, Connors Kelly E, Fadden MK, Freiberg MS, Wells QS, Canedo J, Tyndale RF, Young RP, Hopkins RJ, Tindle HA. Feasibility of precision smoking treatment in a low-income community setting: results of a pilot randomized controlled trial in The Southern Community Cohort Study. Addict Sci Clin Pract. 2024 Mar 15;19(1):16. doi: 10.1186/s13722-024-00441-1. |
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There is no plan to make individual participant data (IPD) available to other researchers or institutions.
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Begin enrollment (Baseline survey) for verbal consent, randomize on receipt of written consent. Analysis performed on randomized participants who completed the Results Call (those who "began" the pilot trial).
Mailed and Phone outreach to enrolled SCCS participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy NCI "Clearing the Air": 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. |
| FG001 | Nicotine Metabolite Ratio (PC-NMR) | Group 1, nicotine metabolism. Medication is guided by nicotine metabolism. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication. NCI "Clearing the Air": 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. |
| FG002 | 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. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers. NCI "Clearing the Air": 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomized participants who completed the Results Call, allowing for the intervention to be assigned and begin
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy NCI "Clearing the Air": 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Randomized participants who completed the Results Call, allowing for the intervention to be assigned and begin | Posted | Count of Participants | Participants | Full trial: Baseline - 6 month survey |
|
Full trial: Baseline - 6 month survey
Assessed at each survey timepoint for randomized participants who completed the Results Call (those who "began" the pilot trial)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy NCI "Clearing the Air": 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation and/or Irritability | Psychiatric disorders | Systematic Assessment |
Due to the small sample size of this pilot feasibility study, we cannot draw conclusions about differences across study arms. Larger follow-up studies are needed to test the efficacy of these precision approaches compared to guideline based care.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen King | Vanderbilt University Medical Center | 615-875-9394 | stephen.king@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2018 | Apr 9, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000095488 | Nicotine Replacement Therapy |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Assessing parallel precision care interventions (groups 1, 2) and control group.
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Assessors will be blind to participant arm assignment until delivery of lab results at month 6.
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| Varenicline | Drug | FDA-approved smoking cessation pharmacotherapy |
|
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| Nicotine metabolism | Genetic | Information on nicotine metabolism will be used to inform selection of medication. |
|
| Genetically-informed lung cancer risk score | Genetic | This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers. |
|
| NCI "Clearing the Air" | Behavioral | 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. |
|
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 |
| BG001 | Nicotine Metabolite Ratio (PC-NMR) | Group 1, nicotine metabolism. Medication is guided by nicotine metabolism. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication. NCI "Clearing the Air": 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. |
| BG002 | 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. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers. NCI "Clearing the Air": 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Nicotine Metabolite Ratio (PC-NMR) | Group 1, nicotine metabolism. Medication is guided by nicotine metabolism. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication. NCI "Clearing the Air": 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. |
| OG002 | 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. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers. NCI "Clearing the Air": 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. |
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| Secondary | 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 | Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased) | Posted | Count of Participants | Participants | Full trial: Baseline - 6 month survey |
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|
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| Secondary | Cessation History - Medication Use | Participants who received, and those who subsequently used, a smoking cessation medication during the trial | Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased) | Posted | Count of Participants | Participants | Full trial: Baseline - 6 month survey |
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|
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| Secondary | Cessation History - Quitline | Participants who reported using the quitline ("phone support") at any point during the trial | Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased) | Posted | Count of Participants | Participants | Full trial: Baseline - 6 month survey |
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| Secondary | Cessation History - Self-reported Abstinence | Participants who self-reported abstinence at the 6 month survey | Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased) | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Cessation History - Validated Abstinence | Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml) | Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased) | Posted | Count of Participants | Participants | 6 months |
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|
| 1 |
| 19 |
| 0 |
| 19 |
| 19 |
| 19 |
| EG001 | Nicotine Metabolite Ratio (PC-NMR) | Group 1, nicotine metabolism. Medication is guided by nicotine metabolism. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Nicotine metabolism: Information on nicotine metabolism will be used to inform selection of medication. NCI "Clearing the Air": 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. | 0 | 19 | 0 | 19 | 18 | 19 |
| EG002 | 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. Nicotine patch: FDA-approved smoking cessation pharmacotherapy Varenicline: FDA-approved smoking cessation pharmacotherapy Genetically-informed lung cancer risk score: This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers. NCI "Clearing the Air": 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. | 1 | 20 | 0 | 20 | 17 | 20 |
| Anger | Psychiatric disorders | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | Systematic Assessment |
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| Anxiety (includes nervousness and panic attacks) | Psychiatric disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Abnormal dreams and/or nightmares | Nervous system disorders | Systematic Assessment |
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| Insomnia and/or other sleep | Nervous system disorders | Systematic Assessment |
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| Headaches | Nervous system disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Nausea and/or vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other symptom | General disorders | Systematic Assessment |
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| Hospitalization | Surgical and medical procedures | Systematic Assessment | Hospitalizations during the course of the study judged to be unrelated to study procedures |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
|
|