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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

NCT00032084 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-03-11

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

smoking cessation intervention

Physician will deliver the smoking cessation advice, reinforce the established quit date (no sooner than seven days after starting bupropion/placebo), and will distribute patient educational materials and all pharmacotherapy

DRUG

bupropion hydrochloride

150 mg/day on Days 1-3, 300 mg/day on Day 4-77

DRUG

nicotine

21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.

PROCEDURE

psychosocial assessment and care

The nurse/CRA will debrief the patients after the brief physician intervention and will follow-up with a series of 5 phone calls to provide booster advice. All advice will be based on the stage of change model (i.e., tailored to the patient's readiness to quit and/or stay off cigarettes).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Ellen R. Gritz, PhD · M.D. Anderson Cancer Center

  • Philip C. Hoffman, MD · University of Chicago

  • James Stevenson, MD · Presbyterian medical center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2004-02-29
Completion
2004-02-29

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00032084 on ClinicalTrials.gov