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CompletedNCT00002520Updated Jun 15, 2023

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

An interventional study of nicotine and Usual Care in Bladder Cancer, Breast Cancer and Colorectal Cancer, sponsored by Eastern Cooperative Oncology Group. Completed at 1 site in United States. Open to participants aged 19 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Eastern Cooperative Oncology Group · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 years 10 months after the study started (first participant enrolled Dec 1990, registered Nov 1999).
Phase
Not applicable
Study type
Interventional
Enrollment
434
Allocation
Randomized
Ages
19 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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

Keywords

  • 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
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • primary central nervous system lymphoma
  • tobacco use disorder
  • stage I adenoid cystic carcinoma of the oral cavity
  • stage I adult T-cell leukemia/lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult Burkitt lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I basal cell carcinoma of the lip
  • stage I cutaneous T-cell non-Hodgkin lymphoma
  • stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I inverted papilloma of the paranasal sinus and nasal cavity
  • stage I lymphoepithelioma of the nasopharynx
  • stage I lymphoepithelioma of the oropharynx
  • stage I mantle cell lymphoma
  • stage I midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage I mucoepidermoid carcinoma of the oral cavity
  • stage I mycosis fungoides/Sezary syndrome
  • stage I non-small cell lung cancer
  • stage I prostate cancer
  • stage I rectal cancer
  • stage I squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the nasopharynx
  • stage I squamous cell carcinoma of the oropharynx
  • stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage I malignant testicular germ cell tumor
  • stage I verrucous carcinoma of the larynx
  • stage I verrucous carcinoma of the oral cavity
  • stage II adult T-cell leukemia/lymphoma
  • stage II adenoid cystic carcinoma of the oral cavity
  • stage II basal cell carcinoma of the lip
  • stage II bladder cancer
  • stage II breast cancer
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage II inverted papilloma of the paranasal sinus and nasal cavity
  • stage II lymphoepithelioma of the nasopharynx
  • stage II lymphoepithelioma of the oropharynx
  • stage II midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage II mucoepidermoid carcinoma of the oral cavity
  • stage II mycosis fungoides/Sezary syndrome
  • stage I bladder cancer
  • stage II non-small cell lung cancer
  • stage II prostate cancer
  • stage II rectal cancer
  • stage II squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the nasopharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage II malignant testicular germ cell tumor
  • stage II verrucous carcinoma of the larynx
  • stage II verrucous carcinoma of the oral cavity
  • stage III adult T-cell leukemia/lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage III prostate cancer
  • stage III malignant testicular germ cell tumor
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV breast cancer
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV mycosis fungoides/Sezary syndrome
  • stage IV prostate cancer
  • unspecified adult solid tumor, protocol specific
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 434 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
434 participants (actual)

Study arms

  • 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

Interventions

  • Drugnicotine
  • BehavioralUsual Care
06

What researchers measure

Primary outcomes

  1. Rate of Smoking Cessation at 6 months

    Proportion of patients who have quit smoking 6 months after the intervention

    Time frame: Assessed at 6 months

07

Study locations

1 site
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
08

References and documents

Publications

  • Schnoll RA, Zhang B, Rue M, Krook JE, Spears WT, Marcus AC, Engstrom PF. Brief physician-initiated quit-smoking strategies for clinical oncology settings: a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2003 Jan 15;21(2):355-65. doi: 10.1200/JCO.2003.04.122. PubMed 12525530 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00002520
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 11, 2003
Start date
Dec 7, 1990
Primary completion
Feb 2002
Last update
Jun 15, 2023

Study contacts

Paul F. Engstrom, MD
study chair · Fox Chase Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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