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
Acronym
Not provided
Organization
Eastern Cooperative Oncology GroupNETWORK
Status Module
Record Verification Date
Jun 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 7, 1990Actual
Primary Completion Date
Feb 2002Actual
Completion Date
Not provided
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Aug 8, 2003
First Posted Date
Aug 11, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 14, 2023
Last Update Posted Date
Jun 15, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eastern Cooperative Oncology GroupNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
434Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Quit Smoking Intervention
Experimental
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
Usual Care
Active Comparator
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
Name
Type
Description
Arm Group Labels
Other Names
nicotine
Drug
Quit Smoking Intervention
Usual Care
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Rate of Smoking Cessation at 6 months
Proportion of patients who have quit smoking 6 months after the intervention
Assessed at 6 months
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Behavioral
Usual Care
ID
Term
D001749
Urinary Bladder Neoplasms
D001943
Breast Neoplasms
D015179
Colorectal Neoplasms
D006258
Head and Neck Neoplasms
D008175
Lung Neoplasms
D008223
Lymphoma
D011471
Prostatic Neoplasms
C563236
Testicular Germ Cell Tumor
D014029
Tobacco Use Disorder
D006689
Hodgkin Disease
D007119
Immunoblastic Lymphadenopathy
D003110
Colonic Neoplasms
D017728
Lymphoma, Large-Cell, Anaplastic
D064090
Intraocular Lymphoma
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D016403
Lymphoma, Large B-Cell, Diffuse
D008228
Lymphoma, Non-Hodgkin
D002051
Burkitt Lymphoma
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D016410
Lymphoma, T-Cell, Cutaneous
D018304
Esthesioneuroblastoma, Olfactory
D008224
Lymphoma, Follicular
D020522
Lymphoma, Mantle-Cell
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D002289
Carcinoma, Non-Small-Cell Lung
D012004
Rectal Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D013736
Testicular Neoplasms
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
Ancestor Terms
ID
Term
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications