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

NCT02856581

Last updated date
Study Location
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Lung CarcinomaManagement of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
NCT02856581
  1. Denver, Colorado
  2. Englewood, Colorado
  3. Gainesville, Florida
  4. Atlanta, Georgia
  5. Michigan City, Indiana
  6. Flint, Michigan
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  266. Poughkeepsie, New York
  267. Rochester, New York
  268. Greenville, North Carolina
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  270. Beavercreek, Ohio
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  331. Charlottesville, Virginia
  332. Charlottesville, Virginia
  333. Fishersville, Virginia
  334. Norfolk, Virginia
  335. Auburn, Washington
  336. Bainbridge Island, Washington
  337. Bellevue, Washington
  338. Federal Way, Washington
  339. Gig Harbor, Washington
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  341. Kennewick, Washington
  342. Lynnwood, Washington
  343. Port Townsend, Washington
  344. Poulsbo, Washington
  345. Puyallup, Washington
  346. Puyallup, Washington
  347. Renton, Washington
  348. Seattle, Washington
  349. Spokane Valley, Washington
  350. Spokane, Washington
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  352. Tacoma, Washington
  353. Tacoma, Washington
  354. Tacoma, Washington
  355. Yakima, Washington
  356. La Crosse, Wisconsin
  357. Milwaukee, Wisconsin
  358. Cheyenne, Wyoming
  359. Cody, Wyoming
  360. Sheridan, Wyoming
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 19, 2019)
23
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2016)
783
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 information is only displayed when the study is recruiting subjects
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, PhDMayo
PRS Account Alliance for Clinical Trials in Oncology
Verification Date November 2019

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