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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002520
Recruitment Status : Completed
First Posted : August 11, 2003
Last Update Posted : October 7, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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 : June 1992
Actual Primary Completion Date : February 2002

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 19 and over


  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No history of recent heart attack


  • Not pregnant
  • No other imminent medical needs requiring referral to a more intensive smoking cessation regimen


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No prior participation in the pilot phase study

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002520

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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Paul F. Engstrom, MD Fox Chase Cancer Center
Publications of Results:
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Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT00002520    
Other Study ID Numbers: CDR0000078281
U10CA021115 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2003    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by Eastern Cooperative Oncology Group:
stage I adult Hodgkin lymphoma
angioimmunoblastic T-cell lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage I colon cancer
stage II colon cancer
stage I breast cancer
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
anaplastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult lymphoblastic lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II mantle cell lymphoma
intraocular lymphoma
limited stage small cell lung cancer
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Germ Cell and Embryonal
Tobacco Use Disorder
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders