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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00002520
First received: November 1, 1999
Last updated: November 30, 2012
Last verified: November 2012
  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
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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00002520     History of Changes
Other Study ID Numbers: CDR0000078281, U10CA021115, E-1Y92, NCI-P93-0042
Study First Received: November 1, 1999
Last Updated: November 30, 2012
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
Lung Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Lymphoma
Breast Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Urologic Neoplasms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on September 22, 2014