Completed

Brief Physician-Initiated Quit Smoking Strategies for Clinical Oncology Settings

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What is being tested

nicotine

+ Usual Care

DrugBehavioral
Who is being recruted

Lymphadenopathy+103

+ Urogenital Diseases

+ Genital Diseases

From 19 to 120 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: December 1990
See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: June 15, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: December 7, 1990

Actual date on which the first participant was enrolled.

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.

NCT00002520
Principal SponsorEastern Cooperative Oncology Group
Last updated: June 15, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

434 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LymphadenopathyUrogenital DiseasesGenital DiseasesMental DisordersUrinary Bladder DiseasesBreast DiseasesBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Squamous CellChronic DiseaseColonic DiseasesCranial Nerve DiseasesDigestive System DiseasesDigestive System NeoplasmsDNA Virus InfectionsEndocrine System DiseasesEndocrine Gland NeoplasmsEye NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleGonadal DisordersHematologic DiseasesHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsIntestinal DiseasesIntestinal NeoplasmsLeukemiaLeukemia, LymphoidLung DiseasesLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNeuroblastomaPathologic ProcessesProstatic DiseasesRectal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesPathological Conditions, Signs and SymptomsTesticular DiseasesThoracic NeoplasmsTumor Virus InfectionsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsVirus DiseasesLeukemia, B-CellLymphoma, B-CellLymphoma, T-CellSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialSubstance-Related DisordersEpstein-Barr Virus InfectionsOlfactory Nerve DiseasesDisease AttributesFemale Urogenital DiseasesMale Urogenital DiseasesChemically-Induced DisordersSquamous Cell Carcinoma of Head and NeckUrinary Bladder NeoplasmsBreast NeoplasmsBurkitt LymphomaCarcinoma, Non-Small-Cell LungColonic NeoplasmsHead and Neck NeoplasmsHodgkin DiseaseImmunoblastic LymphadenopathyLung NeoplasmsLymphomaLymphoma, FollicularLymphoma, Non-HodgkinMycosis FungoidesProstatic NeoplasmsRectal NeoplasmsSezary SyndromeTesticular NeoplasmsTobacco Use DisorderColorectal NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, Large-Cell, AnaplasticEsthesioneuroblastoma, OlfactoryLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular Lymphoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Fox Chase Cancer Center

Philadelphia, United StatesOpen Fox Chase Cancer Center in Google Maps
CompletedOne Study Center