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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Bladder Cancer; Breast Cancer; Head and Neck Cancer; Tobacco Use Disorder; Unspecified Adult Solid Tumor, Protocol Specific; Lung Cancer; Lymphoma; Prostate Cancer; Testicular Germ Cell Tumor
• Interventions: Drug: nicotine; Behavioral: Usual Care

• Registration Number: NCT00002520
• Lead Sponsor: Eastern Cooperative Oncology Group

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.

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 Timeline

• Study Start: 1990-12-07
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-02
• Study First Submitted QC: 2003-08-08
• Study First Posted: 2003-08-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quit Smoking Intervention	nicotine	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.
Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Rate of Smoking Cessation at 6 months	Assessed at 6 months	Proportion of patients who have quit smoking 6 months after the intervention

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States