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

Eastern Cooperative Oncology Group

Status: Completed

Conditions: Breast Cancer; Tobacco Use Disorder; Bladder Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Lung Cancer; Lymphoma; Head and Neck Cancer; Prostate Cancer; Testicular Germ Cell Tumor; Colorectal Cancer

Treatments: Behavioral: Usual Care; Drug: nicotine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00002520

CDR0000078281

NCI-P93-0042

E-1Y92

U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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.

Enrollment: 434 patients

Sex: All

Ages: 19 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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434 participants in 2 patient groups

Quit Smoking Intervention

Experimental group

Description:

Patients received advice and help to quit smoking. The intervention employed physician and patient resources that had already been developed and evaluated or pre-tested, including written materials, prescriptions for nicotine replacement, counseling, and follow-up contact.

Treatment:

Drug: nicotine

Usual Care

Active Comparator group

Description:

No special intervention after randomization. "Usual care" may or may not include advice or assistance to stop smoking. Physicians were reassured that "usual care" did not preclude quit smoking counseling.

Treatment:

Behavioral: Usual Care