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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002520
  Purpose

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
Lymphoma
Prostate Cancer
Testicular Germ Cell Tumor
Tobacco Use Disorder
Unspecified Adult Solid Tumor, Protocol Specific
Drug: nicotine

Genetics Home Reference related topics:   bladder cancer    breast cancer   

MedlinePlus related topics:   Bladder Cancer    Breast Cancer    Cancer    Colorectal Cancer    Fungal Infections    Head and Neck Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lung Cancer    Lymphoma    Prostate Cancer    Smoking    Testicular Cancer   

ChemIDplus related topics:   Nicotine polacrilex    Nicotine tartrate    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Active Control
Official Title:   Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   June 1992

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.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

PATIENT CHARACTERISTICS:

Age:

  • 19 and over

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No history of recent heart attack

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior participation in the pilot phase study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002520

Locations
United States, Pennsylvania
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Paul F. Engstrom, MD     Fox Chase Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000078281, E-1Y92, NCI-P93-0042
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002520
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Nicotine polacrilex
Thoracic Neoplasms
Sezary syndrome
Prostatic Diseases
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Colonic Diseases
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Urologic Neoplasms
Rectal Diseases
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Mycoses
Smoking
Carcinoma, Adenoid Cystic
Lung Neoplasms
Substance-Related Disorders
Lymphoma, Large-Cell, Anaplastic
Laryngeal carcinoma
Rectal cancer
Hodgkin Disease
Breast Diseases
Non-small cell lung cancer
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Tobacco Use Disorder
Urinary Bladder Diseases

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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