Trial Outcomes & Findings for PRecision Interventions for SMoking in the SCCS (NCT NCT03521141)
NCT ID: NCT03521141
Last Updated: 2020-06-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
67 participants
Primary outcome timeframe
Full trial: Baseline - 6 month survey
Results posted on
2020-06-01
Participant Flow
Mailed and Phone outreach to enrolled SCCS participants.
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).
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
Baseline Characteristics
PRecision Interventions for SMoking in the SCCS
Baseline characteristics by cohort
| Measure |
Guideline-Based Care (GBC)
n=19 Participants
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 Participants
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.
|
Respiragene (PC-Respiragene)
n=20 Participants
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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.49 years
n=5 Participants
|
62.23 years
n=7 Participants
|
57.92 years
n=5 Participants
|
59.24 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
20 participants
n=5 Participants
|
58 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Full trial: Baseline - 6 month surveyPopulation: Randomized participants who completed the Results Call, allowing for the intervention to be assigned and begin
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.
Outcome measures
| Measure |
Guideline-Based Care (GBC)
n=19 Participants
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 Participants
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.
|
Respiragene (PC-Respiragene)
n=20 Participants
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.
|
|---|---|---|---|
|
Intervention Feasibility: Ability to Retain Participants
Started Pilot Trial (completed results call)
|
19 Participants
|
19 Participants
|
20 Participants
|
|
Intervention Feasibility: Ability to Retain Participants
Still enrolled at end of pilot trial
|
18 Participants
|
18 Participants
|
19 Participants
|
|
Intervention Feasibility: Ability to Retain Participants
Completed 6 month survey
|
17 Participants
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Full trial: Baseline - 6 month surveyPopulation: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
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
Outcome measures
| Measure |
Guideline-Based Care (GBC)
n=18 Participants
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 Participants
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.
|
Respiragene (PC-Respiragene)
n=19 Participants
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.
|
|---|---|---|---|
|
Cessation History - Quit Attempts
|
16 Participants
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Full trial: Baseline - 6 month surveyPopulation: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
Participants who received, and those who subsequently used, a smoking cessation medication during the trial
Outcome measures
| Measure |
Guideline-Based Care (GBC)
n=18 Participants
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 Participants
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.
|
Respiragene (PC-Respiragene)
n=19 Participants
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.
|
|---|---|---|---|
|
Cessation History - Medication Use
Started/used any cessation medication
|
14 Participants
|
9 Participants
|
14 Participants
|
|
Cessation History - Medication Use
Received any cessation medication
|
17 Participants
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Full trial: Baseline - 6 month surveyPopulation: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
Participants who reported using the quitline ("phone support") at any point during the trial
Outcome measures
| Measure |
Guideline-Based Care (GBC)
n=18 Participants
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 Participants
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.
|
Respiragene (PC-Respiragene)
n=19 Participants
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.
|
|---|---|---|---|
|
Cessation History - Quitline
|
4 Participants
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
Participants who self-reported abstinence at the 6 month survey
Outcome measures
| Measure |
Guideline-Based Care (GBC)
n=18 Participants
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 Participants
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.
|
Respiragene (PC-Respiragene)
n=19 Participants
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.
|
|---|---|---|---|
|
Cessation History - Self-reported Abstinence
|
7 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Randomized participants who completed the Results Call, and were enrolled in the study through the 6 month timepoint (i.e., not withdrawn nor deceased)
Participants who completed a salivary cotinine sample; participants who biochemically-verified as abstinent (salivary cotinine ≤10ng/ml)
Outcome measures
| Measure |
Guideline-Based Care (GBC)
n=18 Participants
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 Participants
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.
|
Respiragene (PC-Respiragene)
n=19 Participants
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.
|
|---|---|---|---|
|
Cessation History - Validated Abstinence
Salivary cotinine sample received by study staff
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Cessation History - Validated Abstinence
Validated as abstinent (cotinine ≤10ng/ml)
|
3 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Guideline-Based Care (GBC)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 1 deaths
Nicotine Metabolite Ratio (PC-NMR)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Respiragene (PC-Respiragene)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Guideline-Based Care (GBC)
n=19 participants at risk
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.
|
Nicotine Metabolite Ratio (PC-NMR)
n=19 participants at risk
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.
|
Respiragene (PC-Respiragene)
n=20 participants at risk
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.
|
|---|---|---|---|
|
Psychiatric disorders
Agitation and/or Irritability
|
63.2%
12/19 • 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)
|
26.3%
5/19 • 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)
|
60.0%
12/20 • 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)
|
|
Psychiatric disorders
Anger
|
68.4%
13/19 • 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)
|
26.3%
5/19 • 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)
|
35.0%
7/20 • 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)
|
|
Psychiatric disorders
Depressed mood
|
57.9%
11/19 • 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)
|
47.4%
9/19 • 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)
|
40.0%
8/20 • 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)
|
|
Psychiatric disorders
Anxiety (includes nervousness and panic attacks)
|
42.1%
8/19 • 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)
|
36.8%
7/19 • 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)
|
35.0%
7/20 • 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)
|
|
General disorders
Restlessness
|
52.6%
10/19 • 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)
|
57.9%
11/19 • 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)
|
20.0%
4/20 • 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)
|
|
Nervous system disorders
Abnormal dreams and/or nightmares
|
31.6%
6/19 • 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)
|
15.8%
3/19 • 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)
|
35.0%
7/20 • 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)
|
|
Nervous system disorders
Insomnia and/or other sleep
|
63.2%
12/19 • 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)
|
63.2%
12/19 • 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)
|
45.0%
9/20 • 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)
|
|
Nervous system disorders
Headaches
|
57.9%
11/19 • 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)
|
42.1%
8/19 • 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)
|
25.0%
5/20 • 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)
|
|
General disorders
Dizziness
|
26.3%
5/19 • 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)
|
21.1%
4/19 • 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)
|
15.0%
3/20 • 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)
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
15.8%
3/19 • 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)
|
21.1%
4/19 • 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)
|
15.0%
3/20 • 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)
|
|
General disorders
Fatigue
|
42.1%
8/19 • 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)
|
42.1%
8/19 • 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)
|
30.0%
6/20 • 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)
|
|
Skin and subcutaneous tissue disorders
Itching
|
26.3%
5/19 • 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)
|
42.1%
8/19 • 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)
|
40.0%
8/20 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
26.3%
5/19 • 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)
|
5.3%
1/19 • 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)
|
15.0%
3/20 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.1%
8/19 • 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)
|
52.6%
10/19 • 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)
|
50.0%
10/20 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
36.8%
7/19 • 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)
|
36.8%
7/19 • 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)
|
25.0%
5/20 • 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)
|
|
General disorders
Other symptom
|
26.3%
5/19 • 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)
|
26.3%
5/19 • 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)
|
30.0%
6/20 • 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)
|
|
Surgical and medical procedures
Hospitalization
|
10.5%
2/19 • 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)
|
15.8%
3/19 • 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)
|
0.00%
0/20 • 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)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place