Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | September 29, 2017 |
End Date: | February 2022 |
Contact: | Ivana Croghan, PhD |
Email: | croghan.ivana@mayo.edu |
Phone: | 507-284-7313 |
Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
This randomized phase III trial studies how well management of a tobacco treatment
intervention works in reducing surgical complications in patients with newly diagnosed lung
cancer who smoke cigarettes. Management of a tobacco treatment intervention compares
varenicline (a drug that reduces the craving and withdrawal symptoms that occur with
abstinence from nicotine) and behavioral interventions (consisting of a brief
clinician-delivered intervention and tobacco quitline [tobacco cessation service available
through a toll-free telephone number] follow-up) with placebo (a pill with no active
medication) along with similar behavioral interventions. It is not yet known whether
management of a tobacco treatment intervention is more effective in reducing surgical
complications than placebo.
intervention works in reducing surgical complications in patients with newly diagnosed lung
cancer who smoke cigarettes. Management of a tobacco treatment intervention compares
varenicline (a drug that reduces the craving and withdrawal symptoms that occur with
abstinence from nicotine) and behavioral interventions (consisting of a brief
clinician-delivered intervention and tobacco quitline [tobacco cessation service available
through a toll-free telephone number] follow-up) with placebo (a pill with no active
medication) along with similar behavioral interventions. It is not yet known whether
management of a tobacco treatment intervention is more effective in reducing surgical
complications than placebo.
PRIMARY OBJECTIVES:
I. To determine if varenicline plus a behavioral intervention consisting of a brief
clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical
complications through 24 weeks after surgery when compared to placebo plus the behavioral
intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.
SECONDARY OBJECTIVES:
I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality
of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention
(varenicline) and control group (placebo).
II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient
quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and
Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.
III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse
("Was It Worth It") each treatment (intervention versus [vs] control groups).
IV. To compare post-operative care (as measured by length of hospital and high dependency
unit stay) between the intervention and control groups.
V. To compare treatment adherence between the intervention and control groups. VI. To compare
rates of smoking abstinence between the intervention and control groups as a covariate of the
primary outcome only.
I. To determine if varenicline plus a behavioral intervention consisting of a brief
clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical
complications through 24 weeks after surgery when compared to placebo plus the behavioral
intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.
SECONDARY OBJECTIVES:
I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality
of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention
(varenicline) and control group (placebo).
II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient
quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and
Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.
III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse
("Was It Worth It") each treatment (intervention versus [vs] control groups).
IV. To compare post-operative care (as measured by length of hospital and high dependency
unit stay) between the intervention and control groups.
V. To compare treatment adherence between the intervention and control groups. VI. To compare
rates of smoking abstinence between the intervention and control groups as a covariate of the
primary outcome only.
- Eligible patients will have a new diagnosis of lung cancer and have sought a surgical
consult relating to this diagnosis
- Surgery must be scheduled no sooner than 10 days after randomization and no more than
twelve weeks after randomization
- Have smoked daily or nearly every day in the previous 6 months up to the date of
surgical consult AND have smoked at least one puff in the previous 7 days
- Motivated to stop smoking, as indicated by a score of 6 or above on the Contemplation
Ladder
- Within the 30 days before registration, no use of: 1) any pharmacologic treatment for
smoking cessation, including bupropion or nicotine replacement therapy; 2) any
nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in
any formal behavioral treatment program for tobacco dependence as determined by
patient report
- No allergies to and not currently using varenicline
- No suicidal thoughts as indicated by a positive (1+) response to the PHQ9
- No active untreated clinically significant psychiatric condition (psychosis, bipolar
disorder, or depression)
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
women of childbearing potential only
* A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in
the preceding 12 consecutive months)
- No unstable angina, myocardial infarction, or coronary angioplasty within the past 3
months or an untreated cardiac dysrhythmia
- No history of seizures
- No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic
disease
- Not currently on renal dialysis or has a history of significant renal impairment
- No recent history (=< 90 days) of substance abuse (outside of tobacco) defined by
National Institute on Alcohol Abuse and Alcoholism (NIAAA) as:
- If male, drinking > 14 alcoholic beverages per week for past 1 month
- If female, drinking > 7 alcoholic beverages per week for past 1 month
- Use of cocaine, heroin, club drugs (i.e., 3,4-methylenedioxymethamphetamine
(MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., lysergic acid
diethylamide [LSD]) at any time during the past 1 month
- Use of marijuana on a weekly basis for the past 1 month
- Patients must be able to complete study questionnaires in English
- No other household member or relative participating in the study
- No known history of any condition or factor judged by the investigator to preclude
participation in the study or which might hinder study adherence
- Calculated creatinine clearance >= 30 mL/min * For females, use 85% of calculated
creatinine clearance (CrCl) value
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Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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31500 Telegraph Road
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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1400 East Boulder Street
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Principal Investigator: Matthew G. Blum
Phone: 719-365-2406
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Colorado Springs, Colorado 80920
Principal Investigator: Matthew G. Blum
Phone: 719-364-6700
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2520 North 5th Street
Columbus, Mississippi 39705
Columbus, Mississippi 39705
Principal Investigator: Edward T. Robbins
Phone: 901-226-1366
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Corbin, Kentucky 40701
Principal Investigator: Nicholas M. Lopez
Phone: 859-523-1934
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
![Geisinger Medical Center](/wp-content/uploads/logos/geisinger-medical-center.jpg)
Principal Investigator: Matthew A. Facktor
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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1 Wyoming St,
Dayton, Ohio 45409
Dayton, Ohio 45409
(937) 208-8000
![Miami Valley Hospital](/wp-content/uploads/logos/miami-valley-hospital.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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2222 Philadelphia Dr
Dayton, Ohio 45406
Dayton, Ohio 45406
(937) 734-2612
![Good Samaritan Hospital - Dayton](/wp-content/uploads/logos/good-samaritan-hospital---dayton.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-832-1093
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Dayton, Ohio 45415
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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2300 N Edward St
Decatur, Illinois 62526
Decatur, Illinois 62526
(217) 876-8121
![Decatur Memorial Hospital](/wp-content/uploads/logos/decatur-memorial-hospital.jpg)
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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210 West McKinley Avenue
Decatur, Illinois 62526
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Detroit, Michigan 48236
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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17900 23 Mile Road
East China Township, Michigan 48054
East China Township, Michigan 48054
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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East Stroudsburg, Pennsylvania 18301
Principal Investigator: Christopher M. Reynolds
Phone: 570-422-1700
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Effingham, Illinois 62401
Principal Investigator: Yujie Zhao
Phone: 800-446-5532
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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1202 East Locust Street
Emmett, Idaho 83617
Emmett, Idaho 83617
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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101 S Major St
Eureka, Illinois 61530
Eureka, Illinois 61530
309-467-2371
![Illinois CancerCare - Eureka](/wp-content/uploads/logos/illinois-cancercare---eureka.jpg)
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Evansville, Indiana 47713
Principal Investigator: Yujie Zhao
Phone: 877-654-0311
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Fairbanks, Alaska 99701
Principal Investigator: John A. Keech
Phone: 907-458-3043
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Federal Way, Washington 98002
Principal Investigator: John A. Keech
Phone: 206-342-6954
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Findlay, Ohio 45840
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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1900 S Main St
Findlay, Ohio 45840
Findlay, Ohio 45840
(419) 423-4500
![Blanchard Valley Hospital](/wp-content/uploads/logos/blanchard-valley-hospital.jpg)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
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![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
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Fishersville, Virginia 22939
Principal Investigator: Kelvin B. Raybon
Phone: 540-245-7106
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Flemington, New Jersey 08822
Principal Investigator: Kenneth B. Blankstein
Phone: 888-788-1260
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Flint, Michigan 48503
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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302 Kensington Avenue
Flint, Michigan 48503
Flint, Michigan 48503
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
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302 Kensington Ave
Flint, Michigan 48503
Flint, Michigan 48503
(810) 762-8490
![Genesys Hurley Cancer Institute](/wp-content/uploads/logos/genesys-hurley-cancer-institute.jpg)
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
1600 S Andrews Ave
Fort Lauderdale, Florida 33316
Fort Lauderdale, Florida 33316
(954) 355-4400
![Broward Health Medical Center](/wp-content/uploads/logos/broward-health-medical-center.png)
Principal Investigator: Mehmet F. Hepgur
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Fort Wayne, Indiana 46805
Principal Investigator: Sushil Jain
Phone: 260-373-8888
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One Medical Center Drive
Franklin, Ohio 45005
Franklin, Ohio 45005
(513) 424-2111
![Atrium Medical Center - Middletown Regional Hospital](/wp-content/uploads/logos/atrium-medical-center---middletown-regional-hospital.png)
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Atrium Medical Center - Middletown Regional Hospital Atrium Medical Center (Atrium) is built on the...
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![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)