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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 : August 6, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 5, 2016
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE September 29, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
  • Mortality [ Time Frame: Up to 30 days post-surgery ]
  • Re-hospitalization [ Time Frame: Up to 30 days post-surgery ]
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2016)
  • Incidence of mortality [ Time Frame: Up to 30 days post-surgery ]
  • Incidence of re-hospitalization [ Time Frame: Up to 30 days post-surgery ]
  • Incidence of pulmonary complications [ Time Frame: Up to 24 weeks post-surgery ]
  • Incidence of intensive care unit readmission [ Time Frame: Up to 24 weeks post-surgery ]
  • Incidence of wound infection (not otherwise specified) [ Time Frame: Up to 24 weeks post-surgery ]
  • Incidence of anastomotic failure [ Time Frame: Up to 24 weeks post-surgery ]
Change History Complete list of historical versions of study NCT02856581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
  • 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).
  • Change in QOL as measured by Was It Worth It assessments [ Time Frame: At 12 weeks after surgery ]
  • Change in QOL as measured by Was It Worth It assessments [ Time Frame: At 24 weeks after surgery ]
  • 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.
  • 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.
  • Expanded complication rate [ Time Frame: Up to 1 year ]
  • Treatment adherence rates related to visits, medication compliance, quitline usage, and surgeon teachable moment delivery [ Time Frame: Up to 12 weeks ]
  • Smoking abstinence rates as measured by self-report [ Time Frame: Up to 12 weeks ]
  • Smoking abstinence rates as measured by salivary cotinine testing [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2016)
  • Change in QOL as measured by the LASA-12 [ Time Frame: Up to 24 weeks post-surgery ]
  • Change in QOL as measured by the PHQ-9 [ Time Frame: Up to 24 weeks post-surgery ]
  • Change in QOL as measured by the SEQ-12 [ Time Frame: Up to 24 weeks post-surgery ]
  • Change in QOL as measured by the Was It Worth It Assessments [ Time Frame: Up to 24 weeks post-surgery ]
  • Post-operative care as measured by length of hospital stay [ Time Frame: Up to 24 weeks post-surgery ]
  • Post-operative care as measured by high dependency unit stay [ Time Frame: Up to 24 weeks post-surgery ]
  • Expanded complication rate [ Time Frame: Up to 24 weeks post-surgery ]
  • Treatment adherence rates related to visits [ Time Frame: Up to 12 weeks ]
  • Treatment adherence rates related to medication compliance [ Time Frame: Up to 12 weeks ]
  • Treatment adherence rates related to quitline usage [ Time Frame: Up to 12 weeks ]
  • Treatment adherence rates related to surgeon teachable moment delivery [ Time Frame: Up to 12 weeks ]
  • Smoking abstinence rates as measured by self-report [ Time Frame: Up to 12 weeks ]
  • Smoking abstinence rates as measured by salivary cotinine testing [ Time Frame: Up to 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Official Title  ICMJE Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Lung Carcinoma
Intervention  ICMJE
  • Drug: Varenicline
    Given PO
  • Drug: Placebo
    Given PO
  • Other: Tobacco Cessation Counseling
    Complete counseling session
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Varenicline
    • Other: Tobacco Cessation Counseling
  • 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.
    Interventions:
    • Drug: Placebo
    • Other: Tobacco Cessation Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2016)
783
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ivana Croghan, PhD 507-284-7313 croghan.ivana@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02856581
Other Study ID Numbers  ICMJE A211401
NCI-2016-00438 ( Registry Identifier: NCI Clinical Trial Reporting Program )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Study Chair: Ivana Croghan, PhD Mayo
PRS Account Alliance for Clinical Trials in Oncology
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP