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Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

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ClinicalTrials.gov Identifier: NCT02856581
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Carcinoma Drug: Varenicline Drug: Placebo Other: Tobacco Cessation Counseling Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 783 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: Varenicline
Given PO

Other: Tobacco Cessation Counseling
Complete counseling session

Placebo Comparator: 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.
Drug: Placebo
Given PO

Other: Tobacco Cessation Counseling
Complete counseling session




Primary Outcome Measures :
  1. Mortality [ Time Frame: Up to 30 days post-surgery ]
  2. Re-hospitalization [ Time Frame: Up to 30 days post-surgery ]
  3. Incidence of pulmonary complications [ Time Frame: Up to 24 weeks post-surgery ]
    Surgical 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.

  4. Incidence of intensive care unit readmission [ Time Frame: Up to 24 weeks post-surgery ]
    Surgical 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.

  5. Incidence of unspecified wound infection [ Time Frame: Up to 24 weeks post-surgery ]
    Surgical 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.

  6. Incidence of anastomotic failure [ Time Frame: Up to 24 weeks post-surgery ]
    Surgical 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.


Secondary Outcome Measures :
  1. Change in QOL as measured by the LASA-12, PHQ-9, SEQ-12 [ Time Frame: Baseline up to 24 weeks after surgery ]
    Analysis of covariance and linear mixed model repeated measures analysis will be used for each assessment domain (LASA-12, PHQ-9, SEQ12).

  2. Change in QOL as measured by Was It Worth It assessments [ Time Frame: At 12 weeks after surgery ]
  3. Change in QOL as measured by Was It Worth It assessments [ Time Frame: At 24 weeks after surgery ]
  4. Length of hospital stay [ Time Frame: The time from surgery until the patient is released from the hospital ]
    Logrank testing of Kaplan-Meier estimates will be used for length of hospital stay and supplemented by Cox models to control for concomitant covariates.

  5. Length of high dependency unit stay [ Time Frame: The time from surgery until the patient is released from the hospital ]
    Logrank 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.

  6. Expanded complication rate [ Time Frame: Up to 1 year ]
  7. Treatment adherence rates related to visits, medication compliance, quitline usage, and surgeon teachable moment delivery [ Time Frame: Up to 12 weeks ]
  8. Smoking abstinence rates as measured by self-report [ Time Frame: Up to 12 weeks ]
  9. Smoking abstinence rates as measured by salivary cotinine testing [ Time Frame: Up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856581


Contacts
Contact: Ivana Croghan, PhD 507-284-7313 croghan.ivana@mayo.edu

  Show 288 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Pfizer
Investigators
Study Chair: Ivana Croghan, PhD Mayo

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02856581     History of Changes
Other Study ID Numbers: A211401
NCI-2016-00438 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs