Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

OBJECTIVES:

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.
Compare the sociodemographic, smoking history, and health status correlates of smoking cessation in patients treated with these regimens.
Determine the feasibility of conducting a cancer prevention and control study in a cooperative group setting by monitoring adherence to the smoking-cessation strategies.

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

One of the following diagnoses:

Stage I or II bladder, colorectal, head and neck, lung, or other cancer
Stage I-III testicular cancer
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

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

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

434

Study ID:

NCT00002520

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There is 1 Location for this study

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Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

434

Study ID:

NCT00002520

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

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