NCT00002520

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
434

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 1990

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 11, 2003

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

11.2 years

First QC Date

November 1, 1999

Last Update Submit

June 14, 2023

Conditions

Bladder CancerBreast CancerColorectal CancerHead and Neck CancerLung CancerLymphomaProstate CancerTesticular Germ Cell TumorTobacco Use DisorderUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage I adult Hodgkin lymphomaangioimmunoblastic T-cell lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage I colon cancerstage II colon cancerstage I breast cancerAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaanaplastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult lymphoblastic lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II mantle cell lymphomaintraocular lymphomalimited stage small cell lung cancernoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomaprimary central nervous system lymphomatobacco use disorderstage I adenoid cystic carcinoma of the oral cavitystage I adult T-cell leukemia/lymphomastage I adult diffuse large cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse small cleaved cell lymphomastage I adult Burkitt lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I basal cell carcinoma of the lipstage I cutaneous T-cell non-Hodgkin lymphomastage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I inverted papilloma of the paranasal sinus and nasal cavitystage I lymphoepithelioma of the nasopharynxstage I lymphoepithelioma of the oropharynxstage I mantle cell lymphomastage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I mucoepidermoid carcinoma of the oral cavitystage I mycosis fungoides/Sezary syndromestage I non-small cell lung cancerstage I prostate cancerstage I rectal cancerstage I squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I squamous cell carcinoma of the lip and oral cavitystage I squamous cell carcinoma of the nasopharynxstage I squamous cell carcinoma of the oropharynxstage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage I malignant testicular germ cell tumorstage I verrucous carcinoma of the larynxstage I verrucous carcinoma of the oral cavitystage II adult T-cell leukemia/lymphomastage II adenoid cystic carcinoma of the oral cavitystage II basal cell carcinoma of the lipstage II bladder cancerstage II breast cancerstage II cutaneous T-cell non-Hodgkin lymphomastage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II lymphoepithelioma of the nasopharynxstage II lymphoepithelioma of the oropharynxstage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II mucoepidermoid carcinoma of the oral cavitystage II mycosis fungoides/Sezary syndromestage I bladder cancerstage II non-small cell lung cancerstage II prostate cancerstage II rectal cancerstage II squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the larynxstage II squamous cell carcinoma of the lip and oral cavitystage II squamous cell carcinoma of the nasopharynxstage II squamous cell carcinoma of the oropharynxstage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage II malignant testicular germ cell tumorstage II verrucous carcinoma of the larynxstage II verrucous carcinoma of the oral cavitystage III adult T-cell leukemia/lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Burkitt lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III mycosis fungoides/Sezary syndromestage III prostate cancerstage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IV adult T-cell leukemia/lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV breast cancerstage IV cutaneous T-cell non-Hodgkin lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV mycosis fungoides/Sezary syndromestage IV prostate cancerunspecified adult solid tumor, protocol specificcontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • Rate of Smoking Cessation at 6 months

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

    Assessed at 6 months

Study Arms (2)

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

nicotineDRUG
Quit Smoking Intervention
Usual CareBEHAVIORAL
Usual Care

Eligibility Criteria

Age19 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • 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.

    PMID: 12525530RESULT

MeSH Terms

Conditions

Urinary Bladder NeoplasmsBreast NeoplasmsColorectal NeoplasmsHead and Neck NeoplasmsLung NeoplasmsLymphomaProstatic NeoplasmsTesticular Germ Cell TumorTobacco Use DisorderHodgkin DiseaseImmunoblastic LymphadenopathyColonic NeoplasmsLymphoma, Large-Cell, AnaplasticIntraocular LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousEsthesioneuroblastoma, OlfactoryLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeCarcinoma, Non-Small-Cell LungRectal NeoplasmsSquamous Cell Carcinoma of Head and NeckTesticular NeoplasmsLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersLymphadenopathyLymphoma, T-CellEye NeoplasmsLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinoma, Squamous CellCarcinomaEndocrine Gland NeoplasmsEndocrine System DiseasesTesticular DiseasesGonadal DisordersLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Paul F. Engstrom, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2003

Study Start

December 7, 1990

Primary Completion

February 1, 2002

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(1)