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.

Condition	Treatment or Intervention
Leukemia Lymphoma Head and Neck Cancer Lung Cancer Eye Cancer Gastrointestinal Cancer Oral Cancer Reproductive Cancer	Procedure: supportive care  Behavior: supportive care/therapy  Behavior: psychosocial assessment/care  Drug: nicotine

Further Study 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.

Ages Eligible for Study:  19 Years and above

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

Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study chairs or principal investigators

Paul F. Engstrom,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000078281; E-1Y92; NCI-P93-0042
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002520
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08