ID

35043

Beschreibung

Cognitive Sequelae of Adjuvant Endocrine Therapy for the Treatment of Breast Cancer in Older Women; ODM derived from: https://clinicaltrials.gov/show/NCT02480218

Link

https://clinicaltrials.gov/show/NCT02480218

Stichworte

Versionen (1)
  1. 12.02.19 12.02.19 -
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See clinicaltrials.gov

Hochgeladen am

12. Februar 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02480218

Englisch

Eligibility Breast Cancer NCT02480218

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal female, age 65 and older
Beschreibung

Postmenopausal state | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
no more than 14 weeks post surgical resection for early stage histologically confirmed hormone receptor positive (hr+) breast cancer (bc) (i.e., tumour size 1-2, node status 0-1, metastasis 0). hr+ bc defined as >1% positive cell staining
Beschreibung

Excision Early-Stage Breast Carcinoma Hormone Receptor Positive | Tumor size | TNM Breast tumor staging | Staining Positive Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C2986665
UMLS CUI [1,3]
C0019929
UMLS CUI [1,4]
C1514241
UMLS CUI [2]
C0475440
UMLS CUI [3]
C0474926
UMLS CUI [4,1]
C0487602
UMLS CUI [4,2]
C1514241
UMLS CUI [4,3]
C0439165
prescribed either tamoxifen, letrozole, or anastrozole
Beschreibung

Tamoxifen | letrozole | anastrozole

Datentyp

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0246421
UMLS CUI [3]
C0290883
fluent in written and spoken english; >grade 5 education; can read large print (with or without correction); can hear normal conversation (with or without a hearing aid)
Beschreibung

Able to write Well English Language | Able to speak fluently English Language | Educational Status Grade | Other Coding | Able to hear Conversation Normal | Hearing Aids | Hearing Aids Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0584993
UMLS CUI [1,2]
C0205170
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0564241
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0013658
UMLS CUI [3,2]
C0441800
UMLS CUI [4]
C3846158
UMLS CUI [5,1]
C0576928
UMLS CUI [5,2]
C0871703
UMLS CUI [5,3]
C0205307
UMLS CUI [6]
C0018768
UMLS CUI [7,1]
C0018768
UMLS CUI [7,2]
C0332197
capacity to provide informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
initiated adjuvant et more than one week before baseline assessment
Beschreibung

Hormone Therapy Adjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
chemotherapy (neoadjuvant or adjuvant)
Beschreibung

Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1298676
UMLS CUI [2]
C0085533
more than one treatment of radiotherapy before baseline assessment
Beschreibung

Therapeutic radiology procedure Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1265611
hormone replacement therapy use 4 weeks prior to baseline assessment
Beschreibung

Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
previous breast cancer or metastatic disease or other malignancy, other than any cancers treated for cure >5 years ago and not having recurred except non-melanoma skin cancers; previous chemotherapy; previous use of selective estrogen receptor modulators (serm) or aromatase inhibitor (ai); distant metastases
Beschreibung

Breast Carcinoma Previous | Neoplasm Metastasis | Cancer Other | Exception Malignant Neoplasm Cured | Exception Recurrent Malignant Neoplasm Absent | Exception Skin carcinoma | Prior Chemotherapy | Selective Estrogen Receptor Modulators | Aromatase Inhibitors | Distant metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0027627
UMLS CUI [3]
C1707251
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C1880198
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1458156
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0699893
UMLS CUI [7]
C1514457
UMLS CUI [8]
C0732611
UMLS CUI [9]
C0593802
UMLS CUI [10]
C1269798
history of or active known cns disease (e.g. known diagnosis of stroke, parkinson's), medical condition impairing cognitive function, including active treatment with medication known to affect cognition, or signs of cognitive impairment on the memory impairment screen
Beschreibung

CNS disorder | Cerebrovascular accident | Parkinson Disease | Medical condition Impairing Cognitive function | Pharmaceutical Preparations Affecting Cognition | Signs Impaired cognition Memory impairment Screen

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0030567
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C0392335
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0009240
UMLS CUI [6,1]
C0311392
UMLS CUI [6,2]
C0338656
UMLS CUI [6,3]
C0233794
UMLS CUI [6,4]
C0220908
history or active known diagnosis of major psychiatric disorder in the last 10 years including bipolar disease, schizophrenia, major depression or self-reported hospitalization for psychiatric illness, alcoholism, or history of alcohol or drug abuse
Beschreibung

Major psychiatric illness | Bipolar Disorder | Schizophrenia | Major Depressive Disorder | Psychiatric hospitalization | Alcoholic Intoxication, Chronic | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C4534351
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0036341
UMLS CUI [4]
C1269683
UMLS CUI [5]
C0748061
UMLS CUI [6]
C0001973
UMLS CUI [7]
C0038586
life expectancy less than two years, acutely ill or delirious
Beschreibung

Life Expectancy | Acute illness | Delirium

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C4061114
UMLS CUI [3]
C0011206
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Ähnliche Modelle

Eligibility Breast Cancer NCT02480218

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Age
Item
postmenopausal female, age 65 and older
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Excision Early-Stage Breast Carcinoma Hormone Receptor Positive | Tumor size | TNM Breast tumor staging | Staining Positive Percentage
Item
no more than 14 weeks post surgical resection for early stage histologically confirmed hormone receptor positive (hr+) breast cancer (bc) (i.e., tumour size 1-2, node status 0-1, metastasis 0). hr+ bc defined as >1% positive cell staining
boolean
C0728940 (UMLS CUI [1,1])
C2986665 (UMLS CUI [1,2])
C0019929 (UMLS CUI [1,3])
C1514241 (UMLS CUI [1,4])
C0475440 (UMLS CUI [2])
C0474926 (UMLS CUI [3])
C0487602 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
Tamoxifen | letrozole | anastrozole
Item
prescribed either tamoxifen, letrozole, or anastrozole
boolean
C0039286 (UMLS CUI [1])
C0246421 (UMLS CUI [2])
C0290883 (UMLS CUI [3])
Able to write Well English Language | Able to speak fluently English Language | Educational Status Grade | Other Coding | Able to hear Conversation Normal | Hearing Aids | Hearing Aids Absent
Item
fluent in written and spoken english; >grade 5 education; can read large print (with or without correction); can hear normal conversation (with or without a hearing aid)
boolean
C0584993 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0564241 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0013658 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C3846158 (UMLS CUI [4])
C0576928 (UMLS CUI [5,1])
C0871703 (UMLS CUI [5,2])
C0205307 (UMLS CUI [5,3])
C0018768 (UMLS CUI [6])
C0018768 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
Informed Consent
Item
capacity to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Adjuvant
Item
initiated adjuvant et more than one week before baseline assessment
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant
Item
chemotherapy (neoadjuvant or adjuvant)
boolean
C0392920 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
Therapeutic radiology procedure Quantity
Item
more than one treatment of radiotherapy before baseline assessment
boolean
C1522449 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hormone replacement therapy
Item
hormone replacement therapy use 4 weeks prior to baseline assessment
boolean
C0282402 (UMLS CUI [1])
Breast Carcinoma Previous | Neoplasm Metastasis | Cancer Other | Exception Malignant Neoplasm Cured | Exception Recurrent Malignant Neoplasm Absent | Exception Skin carcinoma | Prior Chemotherapy | Selective Estrogen Receptor Modulators | Aromatase Inhibitors | Distant metastasis
Item
previous breast cancer or metastatic disease or other malignancy, other than any cancers treated for cure >5 years ago and not having recurred except non-melanoma skin cancers; previous chemotherapy; previous use of selective estrogen receptor modulators (serm) or aromatase inhibitor (ai); distant metastases
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C1707251 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1458156 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])
C1514457 (UMLS CUI [7])
C0732611 (UMLS CUI [8])
C0593802 (UMLS CUI [9])
C1269798 (UMLS CUI [10])
CNS disorder | Cerebrovascular accident | Parkinson Disease | Medical condition Impairing Cognitive function | Pharmaceutical Preparations Affecting Cognition | Signs Impaired cognition Memory impairment Screen
Item
history of or active known cns disease (e.g. known diagnosis of stroke, parkinson's), medical condition impairing cognitive function, including active treatment with medication known to affect cognition, or signs of cognitive impairment on the memory impairment screen
boolean
C0007682 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0030567 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C0392335 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0009240 (UMLS CUI [5,3])
C0311392 (UMLS CUI [6,1])
C0338656 (UMLS CUI [6,2])
C0233794 (UMLS CUI [6,3])
C0220908 (UMLS CUI [6,4])
Major psychiatric illness | Bipolar Disorder | Schizophrenia | Major Depressive Disorder | Psychiatric hospitalization | Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
history or active known diagnosis of major psychiatric disorder in the last 10 years including bipolar disease, schizophrenia, major depression or self-reported hospitalization for psychiatric illness, alcoholism, or history of alcohol or drug abuse
boolean
C4534351 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C1269683 (UMLS CUI [4])
C0748061 (UMLS CUI [5])
C0001973 (UMLS CUI [6])
C0038586 (UMLS CUI [7])
Life Expectancy | Acute illness | Delirium
Item
life expectancy less than two years, acutely ill or delirious
boolean
C0023671 (UMLS CUI [1])
C4061114 (UMLS CUI [2])
C0011206 (UMLS CUI [3])
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