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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002520

Collaborator

National Cancer Institute (NCI) (NIH)

434

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Breast Cancer Colorectal Cancer Head and Neck Cancer Lung Cancer Lymphoma Prostate Cancer Testicular Germ Cell Tumor Tobacco Use Disorder Unspecified Adult Solid Tumor, Protocol Specific	Drug: nicotine Behavioral: Usual Care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

434 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings

Study Start Date :

Jun 1, 1992

Actual Primary Completion Date :

Feb 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quit Smoking Intervention 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.	Drug: nicotine
Active Comparator: Usual Care 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.	Behavioral: Usual Care

Arm

Intervention/Treatment

Experimental: Quit Smoking Intervention

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.

Drug: nicotine

Active Comparator: Usual Care

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.

Behavioral: Usual Care

Outcome Measures

Primary Outcome Measures

Rate of Smoking Cessation at 6 months [Assessed at 6 months]
Proportion of patients who have quit smoking 6 months after the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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