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Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer



Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer

For Condition: Leukemia,Lymphoma,Head and Neck Cancer,Lung Cancer,Eye Cancer,Gastrointestinal Cancer,Oral Cancer,Reproductive Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Physician-initiated smoking cessation strategies may be effective in getting early-stage cancer patients to quit smoking. PURPOSE: Randomized clinical trial to compare the effectiveness of a physician-initiated stop-smoking program with the usual care for patients receiving treatment for early-stage cancer.
Details: OBJECTIVES: I. Compare the efficacy of brief physician-initiated smoking cessation strategies vs usual care in patients with early stage cancer who are undergoing treatment in clinical oncology settings. II. Compare the sociodemographic, smoking history, and health status correlates of smoking cessation in patients treated with these regimens. III. Determine the feasibility of conducting a cancer prevention and control study in a cooperative group setting by monitoring adherence to the smoking-cessation strategies. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive usual care (no special intervention). Arm II: Patients receive smoking-cessation therapy based on the 4-step intervention plan in the "Manual for Physicians" published by the National Cancer Institute. The smoking cessation coordinator and physician provide self-quitting advice and support to the patient via counseling, self-help materials, and referral to a smoking cessation counselor at the Cancer Information Service (CIS). Patients receive nicotine replacement, if indicated. Patients who express an interest in more intensive treatment are referred to local American Cancer Society or American Lung Association clinics and/or advised to call the CIS for additional local program referrals. All patients are followed at 6 and 12 months. Patients who report that they are still smoking and interested in help to quit smoking at the 12-month follow-up interview are encouraged to return to their physicians and contact the CIS for additional help quitting or for a referral to more intensive or specialized treatments in their area. PROJECTED ACCRUAL: A total of 494 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 19 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of stage I or II bladder, colorectal, head and neck, lung, or other cancer OR Diagnosis of stage I-III testicular cancer OR Diagnosis of stage I-IV breast cancer, prostate cancer, or lymphoma Must have smoked 1 or more cigarettes within the past month or define self as a smoker Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior participation in the pilot phase study --Patient Characteristics-- Age: 19 and over Sex: Not specified Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No history of recent heart attack Other: - Not pregnant - No other imminent medical needs requiring referral to a more intensive smoking cessation regimen
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PaulEngstrom,  Study Chair,  Eastern Cooperative Oncology Group

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 


Additional Information:
Study ID Numbers:
  CDR0000078281;  E-1Y92,NCI-P93-0042
Study Start Date: June 1992
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002520

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