Trial Outcomes & Findings for Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes (NCT NCT02856581)
NCT ID: NCT02856581
Last Updated: 2022-07-27
Results Overview
Number of patients that died within 30 days of surgery
TERMINATED
PHASE3
23 participants
Up to 30 days post-surgery
2022-07-27
Participant Flow
Participant milestones
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Baseline characteristics by cohort
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 Participants
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 Participants
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
65.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post-surgeryNumber of patients that died within 30 days of surgery
Outcome measures
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 Participants
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 Participants
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post-surgeryNumber of patients re-hospitalized within 30 days of surgery
Outcome measures
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 Participants
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 Participants
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Re-hospitalization
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks post-surgerySurgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Outcome measures
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 Participants
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 Participants
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Number of Paticipants With Incidence of Pulmonary Complications
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks post-surgerySurgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Outcome measures
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 Participants
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 Participants
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Number of Participants With Incidence of Intensive Care Unit Readmission
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks post-surgerySurgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Outcome measures
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 Participants
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 Participants
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Number of Participants With Incidence of Unspecified Wound Infection
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeks post-surgerySurgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Outcome measures
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 Participants
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 Participants
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>
\> Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Number of Participants With Incidence of Anastomotic Failure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 24 weeks after surgeryAnalysis of covariance and linear mixed model repeated measures analysis will be used for each assessment domain (LASA-12, PHQ-9, SEQ12).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 weeks after surgeryOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 24 weeks after surgeryOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time from surgery until the patient is released from the hospitalLogrank testing of Kaplan-Meier estimates will be used for length of hospital stay and supplemented by Cox models to control for concomitant covariates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time from surgery until the patient is released from the hospitalLogrank testing of Kaplan-Meier estimates will be used for length of high dependency unit stay and supplemented by Cox models to control for concomitant covariates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksOutcome measures
Outcome data not reported
Adverse Events
Intervention Group (Varenicline and Behavioral Intervention)
Control Group (Placebo and Behavioral Intervention)
Serious adverse events
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 participants at risk
Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 participants at risk
Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 2 • 24 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Intervention Group (Varenicline and Behavioral Intervention)
n=12 participants at risk
Tobacco Cessation Counseling: Complete counseling session
|
Control Group (Placebo and Behavioral Intervention)
n=11 participants at risk
Tobacco Cessation Counseling: Complete counseling session
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
|
General disorders
Edema face
|
8.3%
1/12 • Number of events 1 • 24 months
|
0.00%
0/11 • 24 months
|
|
General disorders
Fatigue
|
0.00%
0/12 • 24 months
|
18.2%
2/11 • Number of events 3 • 24 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Personality change
|
8.3%
1/12 • Number of events 1 • 24 months
|
0.00%
0/11 • 24 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Suicidal ideation
|
8.3%
1/12 • Number of events 1 • 24 months
|
0.00%
0/11 • 24 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/12 • 24 months
|
9.1%
1/11 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place