ID

16731

Description

Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00188331

Link

https://clinicaltrials.gov/show/NCT00188331

Keywords

Versions (1)
  1. 8/3/16 8/3/16 -
Uploaded on

August 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Cognition NCT00188331

English

Eligibility Cognition NCT00188331

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Cognition NCT00188331
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed colorectal cancer
Description

Colorectal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0009402
age 18-75
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
full recovery from any post operative sequelae
Description

total recovery sequelae Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0683340
UMLS CUI [1,2]
C0243088
UMLS CUI [1,3]
C0032790
adequate hepatic function as documented by a serum bilirubin < 18 umol/l, and liver function tests (lfts) within 1.5x normal range
Description

Liver function | Serum total bilirubin measurement | Liver Function Tests

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0023901
informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any major pre-existing psychiatric history or dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, other than short acting benzodiazepines for nausea or sleep
Description

Mental disorders Pre-existing | Dementia | Alcohol abuse | On psychotropic medication Causing Cognitive problems | short-acting benzodiazepines | Nausea | Sleep

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0085762
UMLS CUI [4,1]
C3874456
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C3842628
UMLS CUI [5]
C0682884
UMLS CUI [6]
C0027497
UMLS CUI [7]
C0037313
any evidence of metastatic disease other than group c who may have limited metastatic disease. if there is clinical suspicion of central nervous system (cns) involvement patients must have brain imaging (mri or ct scan) prior to recruitment.
Description

Neoplasm Metastasis Evidence | Neoplasm Metastasis Limited | CNS involvement | Imaging of brain | Magnetic Resonance Imaging | X-Ray Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0439801
UMLS CUI [3]
C0449389
UMLS CUI [4]
C0203860
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0040405
ongoing sepsis or uncontrolled infection, including hiv infection
Description

Sepsis Continuous | Communicable Diseases Uncontrolled | HIV Infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0019693
pre-existing neurological condition likely to interfere with ability to perform cognitive testing
Description

nervous system disorder Pre-existing Interferes with cognitive testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0204471
any other severe co-morbidity which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
Description

Comorbidity Severe Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0439801
active cancer within the last 5 years other than squamous or basal cell carcinoma of the skin or cervical cancer in situ (except for crc)
Description

Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma | Carcinoma in situ of uterine cervix | Colorectal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0851140
UMLS CUI [5]
C0009402
previous history of chemotherapy, other than adjuvant chemotherapy for group c metastatic group > 1 year previously
Description

Prior Chemotherapy | Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0085533
minimal english skills such that subjects would be unable to follow simple, written english instructions and to read questionnaires of a grade 8 standard with the help of a research assistant.
Description

literacy skills English Language Minimal | Protocol Compliance | Able to read Questionnaires

Data type

boolean

Alias
UMLS CUI [1,1]
C0678998
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0547040
UMLS CUI [2]
C0525058
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C0034394
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Similar models

Eligibility Cognition NCT00188331

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Cognition NCT00188331
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma
Item
histologically confirmed colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Age
Item
age 18-75
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 months
boolean
C0023671 (UMLS CUI [1])
total recovery sequelae Postoperative
Item
full recovery from any post operative sequelae
boolean
C0683340 (UMLS CUI [1,1])
C0243088 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
Liver function | Serum total bilirubin measurement | Liver Function Tests
Item
adequate hepatic function as documented by a serum bilirubin < 18 umol/l, and liver function tests (lfts) within 1.5x normal range
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0023901 (UMLS CUI [3])
Informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorders Pre-existing | Dementia | Alcohol abuse | On psychotropic medication Causing Cognitive problems | short-acting benzodiazepines | Nausea | Sleep
Item
any major pre-existing psychiatric history or dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, other than short acting benzodiazepines for nausea or sleep
boolean
C0004936 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C3874456 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C3842628 (UMLS CUI [4,3])
C0682884 (UMLS CUI [5])
C0027497 (UMLS CUI [6])
C0037313 (UMLS CUI [7])
Neoplasm Metastasis Evidence | Neoplasm Metastasis Limited | CNS involvement | Imaging of brain | Magnetic Resonance Imaging | X-Ray Computed Tomography
Item
any evidence of metastatic disease other than group c who may have limited metastatic disease. if there is clinical suspicion of central nervous system (cns) involvement patients must have brain imaging (mri or ct scan) prior to recruitment.
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0449389 (UMLS CUI [3])
C0203860 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0040405 (UMLS CUI [6])
Sepsis Continuous | Communicable Diseases Uncontrolled | HIV Infections
Item
ongoing sepsis or uncontrolled infection, including hiv infection
boolean
C0243026 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0019693 (UMLS CUI [3])
nervous system disorder Pre-existing Interferes with cognitive testing
Item
pre-existing neurological condition likely to interfere with ability to perform cognitive testing
boolean
C0027765 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0204471 (UMLS CUI [1,4])
Comorbidity Severe Study Subject Participation Status Limited
Item
any other severe co-morbidity which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
Malignant Neoplasms | Squamous cell carcinoma of skin | Basal cell carcinoma | Carcinoma in situ of uterine cervix | Colorectal Carcinoma
Item
active cancer within the last 5 years other than squamous or basal cell carcinoma of the skin or cervical cancer in situ (except for crc)
boolean
C0006826 (UMLS CUI [1])
C0553723 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
C0009402 (UMLS CUI [5])
Prior Chemotherapy | Chemotherapy, Adjuvant
Item
previous history of chemotherapy, other than adjuvant chemotherapy for group c metastatic group > 1 year previously
boolean
C1514457 (UMLS CUI [1])
C0085533 (UMLS CUI [2])
literacy skills English Language Minimal | Protocol Compliance | Able to read Questionnaires
Item
minimal english skills such that subjects would be unable to follow simple, written english instructions and to read questionnaires of a grade 8 standard with the help of a research assistant.
boolean
C0678998 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2])
C0586740 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
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