S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery
- Conditions
- Lung Cancer
- Interventions
- Behavioral: smoking cessation interventionProcedure: psychosocial assessment and care
- Registration Number
- NCT00032084
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: A program that includes bupropion may be more effective in helping early-stage lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is more effective with or without bupropion.
PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit smoking with or without bupropion in treating patients who have undergone surgery for stage I or stage II non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the effect of a smoking cessation intervention comprising behavior intervention and nicotine replacement with or without bupropion on 12-month quit rates in patients with completely resected stage I or II non-small cell lung cancer who are current smokers.
* Compare the predictors of smoking cessation success in patients treated with these regimens.
* Determine the relationship between smoking cessation and standard outcome measures (e.g., second malignancies, survival, and symptom status) in patients treated with these regimens.
* Compare the effect of these treatment regimens on emotional functioning in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to gender, prior neoadjuvant or concurrent adjuvant chemotherapy and/or radiotherapy (yes vs no), and time since prior surgery (less than 6 months vs 6 to 12 months vs more than 12 months). Patients are randomized to 1 of 2 arms.
All patients receive behavioral intervention comprising smoking cessation advice and education on day 1. Patients quit smoking on day 8. Patients then receive a nicotine transdermal patch once daily on days 8-77.
* Arm I: Patients receive oral bupropion once daily on days 1-3 and twice daily on days 4-77.
* Arm II: Patients receive oral placebo as in arm I. Patients are followed at 3, 6, and 12 months and then annually for 10 years.
PROJECTED ACCRUAL: A total of 468 patients (234 \[117 men and 117 women\] per arm) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Behavioral Intervention + Placebo psychosocial assessment and care Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo. Behavioral Intervention + Placebo smoking cessation intervention Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo. Behavioral Intervention + Bupropion smoking cessation intervention Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride . Behavioral Intervention + Bupropion bupropion hydrochloride Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride . Behavioral Intervention + Bupropion nicotine Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride . Behavioral Intervention + Bupropion psychosocial assessment and care Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride . Behavioral Intervention + Placebo nicotine Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.
- Primary Outcome Measures
Name Time Method To compare the effect on 12 month quit rates of adding an anti-depressant versus placebo in a double blind to an intervention and nicotine replacement in complete resected Stage I and II non-small cell lung cancer patients who are current smokers 12 months
- Secondary Outcome Measures
Name Time Method To assess predictors of successful cessation in male and female patients. 12 months To explore the relationship between smoking cessation and standard outcome measures. 12 months To compare the effect on emotional functioning of adding bupropion to a behavioral intervention plus nicotine replacement in this patient population. 12 months
Trial Locations
- Locations (176)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
Kansas Cancer Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Lombardi Cancer Center of Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
Ministry Medical Group - Northern Region
🇺🇸Rhinelander, Wisconsin, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Green Mountain Oncology Group
🇺🇸Bennington, Vermont, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
🇺🇸Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
🇺🇸Hollywood, Florida, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
University of Massachusetts Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Norris Cotton Cancer Center at Dartmouth Medical School
🇺🇸Lebanon, New Hampshire, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
🇺🇸Kinston, North Carolina, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
FirstHealth Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Danville Radiation Therapy Center
🇺🇸Memphis, Tennessee, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
🇵🇷San Juan, Puerto Rico