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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group Identifier:
First received: November 1, 1999
Last updated: October 6, 2015
Last verified: October 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 Intervention
Bladder Cancer
Breast Cancer
Colorectal Cancer
Head and Neck Cancer
Lung Cancer
Prostate Cancer
Testicular Germ Cell Tumor
Tobacco Use Disorder
Unspecified Adult Solid Tumor, Protocol Specific
Drug: nicotine
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings

Resource links provided by NLM:

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Rate of Smoking Cessation at 6 months [ Time Frame: Assessed at 6 months ] [ Designated as safety issue: No ]
    Proportion of patients who have quit smoking 6 months after the intervention

Enrollment: 434
Study Start Date: June 1992
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   19 Years to 120 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00002520

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Paul F. Engstrom, MD Fox Chase Cancer Center
  More Information

Additional Information:
Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT00002520     History of Changes
Other Study ID Numbers: CDR0000078281, U10CA021115, E-1Y92, NCI-P93-0042
Study First Received: November 1, 1999
Last Updated: October 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
tobacco use disorder
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

Additional relevant MeSH terms:
Tobacco Use Disorder
Head and Neck Neoplasms
Neoplasms, Germ Cell and Embryonal
Prostatic Neoplasms
Testicular Neoplasms
Urinary Bladder Neoplasms
Chemically-Induced Disorders
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Gonadal Disorders
Mental Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Prostatic Diseases
Substance-Related Disorders
Testicular Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on December 01, 2015