ID

38061

Beschrijving

Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix); ODM derived from: https://clinicaltrials.gov/show/NCT01532232

Link

https://clinicaltrials.gov/show/NCT01532232

Trefwoorden

Versies (1)
  1. 13-09-19 13-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01532232

Engels

Eligibility Breast Cancer NCT01532232

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
msk patients diagnosed with breast cancer or have a mass suspicious of breast cancer at the time of enrollment, as per clinician judgment or emr;
Beschrijving

Breast Carcinoma | Mass Suspicious Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0577559
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0678222
self-reported current cigarette smoker (defined as daily smoking in the past seven days)
Beschrijving

Cigarette smoker | Tobacco use Daily

Datatype

boolean

Alias
UMLS CUI [1]
C0337667
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C0332173
advised to quit smoking by their msk physician and willing to receive smoking cessation counseling and treatment; as per self report
Beschrijving

Patient advised to Refrain from Smoking | Cessation of smoking Counseling Willing | Smoking cessation therapy Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0418832
UMLS CUI [1,2]
C4086797
UMLS CUI [2,1]
C0085134
UMLS CUI [2,2]
C0010210
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C1095963
UMLS CUI [3,2]
C0600109
fluent in english
Beschrijving

Able to speak fluently English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients less than 18 years of age because the safety and efficacy of varenicline have not yet been tested in children;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
evidence of any known or suspected medical contraindications for use of varenicline (e.g., recent (within past two months) cardiovascular instability (including myocardial infarction or unstable angina; uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, or severe congestive heart failure (new york heart association class iii or iv), severe chronic obstructive pulmonary disease; uncontrolled gastrointestinal, hepatic, or endocrine disease; or severe renal impairment.
Beschrijving

Medical contraindication Varenicline | Instability cardiovascular | Myocardial Infarction | Angina, Unstable | Uncontrolled hypertension | Neurologic sequelae Cerebrovascular Disorder | Congestive heart failure Severe New York Heart Association Classification | Severe chronic obstructive pulmonary disease | Gastrointestinal Disease Uncontrolled | Liver disease Uncontrolled | Endocrine System Disease Uncontrolled | Renal Insufficiency Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1569608
UMLS CUI [2]
C0549406
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C1868885
UMLS CUI [6,1]
C0746864
UMLS CUI [6,2]
C0007820
UMLS CUI [7,1]
C0018802
UMLS CUI [7,2]
C0205082
UMLS CUI [7,3]
C1275491
UMLS CUI [8]
C0730607
UMLS CUI [9,1]
C0017178
UMLS CUI [9,2]
C0205318
UMLS CUI [10,1]
C0023895
UMLS CUI [10,2]
C0205318
UMLS CUI [11,1]
C0014130
UMLS CUI [11,2]
C0205318
UMLS CUI [12,1]
C1565489
UMLS CUI [12,2]
C0205082
self-reported evidence of significant psychiatric history (e.g., schizophrenia, unstable bipolar disorder, panic disorder, untreated major depression) sufficient, in the investigators' judgment, to preclude participation in the clinical trial;
Beschrijving

Psychiatric History Study Subject Participation Status Excluded | Schizophrenia | Bipolar Disorder Unstable | Panic Disorder | Major Depressive Disorder Untreated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0748059
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2]
C0036341
UMLS CUI [3,1]
C0005586
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0030319
UMLS CUI [5,1]
C1269683
UMLS CUI [5,2]
C0332155
self-reported evidence of recent substance abuse or heavy alcohol use (> 14 drinks weekly) in the last 6 months;
Beschrijving

Substance Use Disorders | Heavy alcohol consumption units/week

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C2030272
UMLS CUI [2,2]
C0560579
self-reported recent use (in the past 30 days) or planned use of nicotine replacement therapy (nrt) or other fda approved cessation pharmacotherapy (bupropion);
Beschrijving

Nicotine replacement therapy | Nicotine replacement therapy Planned | Cessation Pharmacotherapy Planned | Bupropion

Datatype

boolean

Alias
UMLS CUI [1]
C1278444
UMLS CUI [2,1]
C1278444
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1880019
UMLS CUI [3,2]
C0013216
UMLS CUI [3,3]
C1301732
UMLS CUI [4]
C0085208
pre-menopausal women who are pregnant as per emr
Beschrijving

Premenopausal state | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0032961
women who are breast-feeding as per self-report.
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Breast Cancer NCT01532232

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Mass Suspicious Breast Carcinoma
Item
msk patients diagnosed with breast cancer or have a mass suspicious of breast cancer at the time of enrollment, as per clinician judgment or emr;
boolean
C0678222 (UMLS CUI [1])
C0577559 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
Cigarette smoker | Tobacco use Daily
Item
self-reported current cigarette smoker (defined as daily smoking in the past seven days)
boolean
C0337667 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
Patient advised to Refrain from Smoking | Cessation of smoking Counseling Willing | Smoking cessation therapy Willing
Item
advised to quit smoking by their msk physician and willing to receive smoking cessation counseling and treatment; as per self report
boolean
C0418832 (UMLS CUI [1,1])
C4086797 (UMLS CUI [1,2])
C0085134 (UMLS CUI [2,1])
C0010210 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C1095963 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
Able to speak fluently English Language
Item
fluent in english
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients less than 18 years of age because the safety and efficacy of varenicline have not yet been tested in children;
boolean
C0001779 (UMLS CUI [1])
Medical contraindication Varenicline | Instability cardiovascular | Myocardial Infarction | Angina, Unstable | Uncontrolled hypertension | Neurologic sequelae Cerebrovascular Disorder | Congestive heart failure Severe New York Heart Association Classification | Severe chronic obstructive pulmonary disease | Gastrointestinal Disease Uncontrolled | Liver disease Uncontrolled | Endocrine System Disease Uncontrolled | Renal Insufficiency Severe
Item
evidence of any known or suspected medical contraindications for use of varenicline (e.g., recent (within past two months) cardiovascular instability (including myocardial infarction or unstable angina; uncontrolled hypertension, significant neurological sequelae of cerebrovascular disease, or severe congestive heart failure (new york heart association class iii or iv), severe chronic obstructive pulmonary disease; uncontrolled gastrointestinal, hepatic, or endocrine disease; or severe renal impairment.
boolean
C1301624 (UMLS CUI [1,1])
C1569608 (UMLS CUI [1,2])
C0549406 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
C0746864 (UMLS CUI [6,1])
C0007820 (UMLS CUI [6,2])
C0018802 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C1275491 (UMLS CUI [7,3])
C0730607 (UMLS CUI [8])
C0017178 (UMLS CUI [9,1])
C0205318 (UMLS CUI [9,2])
C0023895 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C0014130 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
C1565489 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
Psychiatric History Study Subject Participation Status Excluded | Schizophrenia | Bipolar Disorder Unstable | Panic Disorder | Major Depressive Disorder Untreated
Item
self-reported evidence of significant psychiatric history (e.g., schizophrenia, unstable bipolar disorder, panic disorder, untreated major depression) sufficient, in the investigators' judgment, to preclude participation in the clinical trial;
boolean
C0748059 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0030319 (UMLS CUI [4])
C1269683 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
Substance Use Disorders | Heavy alcohol consumption units/week
Item
self-reported evidence of recent substance abuse or heavy alcohol use (> 14 drinks weekly) in the last 6 months;
boolean
C0038586 (UMLS CUI [1])
C2030272 (UMLS CUI [2,1])
C0560579 (UMLS CUI [2,2])
Nicotine replacement therapy | Nicotine replacement therapy Planned | Cessation Pharmacotherapy Planned | Bupropion
Item
self-reported recent use (in the past 30 days) or planned use of nicotine replacement therapy (nrt) or other fda approved cessation pharmacotherapy (bupropion);
boolean
C1278444 (UMLS CUI [1])
C1278444 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1880019 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C0085208 (UMLS CUI [4])
Premenopausal state | Pregnancy
Item
pre-menopausal women who are pregnant as per emr
boolean
C0232969 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Breast Feeding
Item
women who are breast-feeding as per self-report.
boolean
C0006147 (UMLS CUI [1])
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