Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
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|ClinicalTrials.gov Identifier: NCT00002520|
Recruitment Status : Completed
First Posted : August 11, 2003
Last Update Posted : October 7, 2015
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||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||434 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings|
|Study Start Date :||June 1992|
|Actual Primary Completion Date :||February 2002|
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.
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
- Rate of Smoking Cessation at 6 months [ Time Frame: Assessed at 6 months ]Proportion of patients who have quit smoking 6 months after the intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002520
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Paul F. Engstrom, MD||Fox Chase Cancer Center|