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)
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, 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
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Scroll for more (166 remaining)Northeast Alabama Regional Medical Center🇺🇸Anniston, Alabama, United States