Clinical trial NCT00002520: Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
Official title: Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-11
Enrollment: 434
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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

Primary outcomes:
measure: Rate of Smoking Cessation at 6 months
timeFrame: Assessed at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Paul F. Engstrom, MD
role: STUDY_CHAIR
References:
citation: 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.