ID

43682

Descrição

Intellectual Impairment in Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00896324

Link

https://clinicaltrials.gov/show/NCT00896324

Palavras-chave

Versões (2)
  1. 22/02/2016 22/02/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00896324

Inglês

Eligibility Breast Cancer NCT00896324

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
3.1.1 primary, non-metastatic breast cancer
Descrição

Malignant neoplasm of breast Primary Non-Metastatic Neoplasm

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1334991
3.1.2 newly diagnosed patients who have not yet begun treatment.
Descrição

newly diagnosed breast cancer

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1518321
UMLS CUI [1,2]
C0006142
3.1.4 female participants age 40-65 years of all ethnicities who speak fluent english will be recruited.
Descrição

age; female; english speaking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0086287
UMLS CUI [3]
C0376245
3.1.5 there are no life expectancy restrictions.
Descrição

life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
3.1.6 karnofsky performance status 70% minimum. ecog will not be employed.
Descrição

karnofsky performance status; ECOG

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
3.1.7 there are no requirements for marrow function. the brain must be free from gross neuropathology and metastases in order to participate.
Descrição

function bone marrow; neuropathology

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1254358
UMLS CUI [1,2]
C0005953
UMLS CUI [2]
C0876934
3.1.8 ability to understand and the willingness to sign a written informed consent document.
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
3.2.1 history of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). non-english speaking. major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. mri contraindications (e.g. metallic implants or devices). distant metastases. see also section 4.2.1.
Descrição

Compliance behavior Limited Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
3.2.2 participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
3.2.3 participants with significant co-morbid diseases known to significant impact neuropsychological function such as alzheimer's or parkinson's will be excluded.
Descrição

comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205494
3.2.4 there are no known risks for allergic reactions to any of the study procedures.
Descrição

hypersensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020517
3.2.5 participants taking certain medications that affect neuropsychological and/or brain function including haldol, aricept, ritalin, etc. will be excluded. most anti-depressants are acceptable. some anti-anxiety medications may not be. each case will be individually reviewed.
Descrição

concomitant medication; ritalin; anti-depressants

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0728759
UMLS CUI [3]
C0003290
3.2.6 there are no other agent-specific exclusion criteria.
Descrição

exclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
3.2.7 pregnant individuals will be excluded as this is a contraindication for the 3 tesla research mri scanner employed by this study but not because of the treatment programs per se. nursing individuals can enroll.
Descrição

pregnant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
3.2.8 patients who are hiv positive will be excluded given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.
Descrição

hiv positive; cognitive function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0392335
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Similar models

Eligibility Breast Cancer NCT00896324

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Malignant neoplasm of breast Primary Non-Metastatic Neoplasm
Item
3.1.1 primary, non-metastatic breast cancer
boolean
C0006142 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1334991 (UMLS CUI [1,3])
newly diagnosed breast cancer
Item
3.1.2 newly diagnosed patients who have not yet begun treatment.
boolean
C1518321 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
age; female; english speaking
Item
3.1.4 female participants age 40-65 years of all ethnicities who speak fluent english will be recruited.
boolean
C0001779 (UMLS CUI [1])
C0086287 (UMLS CUI [2])
C0376245 (UMLS CUI [3])
life expectancy
Item
3.1.5 there are no life expectancy restrictions.
boolean
C0023671 (UMLS CUI [1])
karnofsky performance status; ECOG
Item
3.1.6 karnofsky performance status 70% minimum. ecog will not be employed.
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
function bone marrow; neuropathology
Item
3.1.7 there are no requirements for marrow function. the brain must be free from gross neuropathology and metastases in order to participate.
boolean
C1254358 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0876934 (UMLS CUI [2])
informed consent
Item
3.1.8 ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Compliance behavior Limited Comorbidity
Item
3.2.1 history of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). non-english speaking. major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. mri contraindications (e.g. metallic implants or devices). distant metastases. see also section 4.2.1.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Study Subject Participation Status
Item
3.2.2 participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.
boolean
C2348568 (UMLS CUI [1])
comorbidity
Item
3.2.3 participants with significant co-morbid diseases known to significant impact neuropsychological function such as alzheimer's or parkinson's will be excluded.
boolean
C0009488 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
hypersensitivity
Item
3.2.4 there are no known risks for allergic reactions to any of the study procedures.
boolean
C0020517 (UMLS CUI [1])
concomitant medication; ritalin; anti-depressants
Item
3.2.5 participants taking certain medications that affect neuropsychological and/or brain function including haldol, aricept, ritalin, etc. will be excluded. most anti-depressants are acceptable. some anti-anxiety medications may not be. each case will be individually reviewed.
boolean
C2347852 (UMLS CUI [1])
C0728759 (UMLS CUI [2])
C0003290 (UMLS CUI [3])
exclusion criteria
Item
3.2.6 there are no other agent-specific exclusion criteria.
boolean
C0680251 (UMLS CUI [1])
pregnant
Item
3.2.7 pregnant individuals will be excluded as this is a contraindication for the 3 tesla research mri scanner employed by this study but not because of the treatment programs per se. nursing individuals can enroll.
boolean
C0032961 (UMLS CUI [1])
hiv positive; cognitive function
Item
3.2.8 patients who are hiv positive will be excluded given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.
boolean
C0019699 (UMLS CUI [1])
C0392335 (UMLS CUI [2])
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