ID

41181

Descrição

Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies; ODM derived from: https://clinicaltrials.gov/show/NCT01877070

Link

https://clinicaltrials.gov/show/NCT01877070

Palavras-chave

Versões (1)
  1. 06/07/2020 06/07/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de julho de 2020

DOI

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Licença

Creative Commons BY-NC 4.0
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Eligibility Low Risk Prostate Cancer NCT01877070

Inglês

Eligibility Low Risk Prostate Cancer NCT01877070

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
for patients:
Descrição

Patients

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030705
men who meet the nccn guidelines for low risk prostate cancer, which include all of the following:
Descrição

Gender Fulfill NCCN Guidelines | Low risk Prostate carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C1513893
UMLS CUI [1,4]
C0162791
UMLS CUI [2,1]
C5201228
UMLS CUI [2,2]
C0600139
most recent gleason score ≤ 6, or clinical stage t1a or less;
Descrição

Gleason score | TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3203027
UMLS CUI [2]
C3258246
most recent psa level below 10;
Descrição

Prostate specific antigen measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201544
in the most recent biopsy, had fewer than 3 positive biopsy cores (with ≤ 50% cancer in each); or the patient's doctor discussed active surveillance as a treatment option (as documented in visit notes of the patient's medical record)
Descrição

Core needle biopsy Positive Quantity | Malignant Neoplasm Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0439165
are able to speak, read, write and understand english well enough to provide informed consent and complete study tasks
Descrição

Able to speak English Language | Able to read English Language | Able to write English Language | Comprehension English Language | Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376245
UMLS CUI [4,1]
C0233733
UMLS CUI [4,2]
C0376245
UMLS CUI [5]
C0021430
UMLS CUI [6]
C0525058
has not made a treatment decision prior to consent, as per self report
Descrição

Absence Decision Making Treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0011109
UMLS CUI [1,3]
C0087111
18 years of age or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
for partners/close allies:
Descrição

Partner

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0682323
considered a partner/close ally to the patient in the treatment making decision, as reported by the patient
Descrição

Partner Decision Making Treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C0011109
UMLS CUI [1,3]
C0087111
are able to speak, read, write and understand english well enough to provide informed consent and complete study tasks
Descrição

Able to speak English Language | Able to read English Language | Able to write English Language | Comprehension English Language | Informed Consent | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376245
UMLS CUI [4,1]
C0233733
UMLS CUI [4,2]
C0376245
UMLS CUI [5]
C0021430
UMLS CUI [6]
C0525058
18 years old or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
for patients:
Descrição

Patients

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030705
history of a cancer other than prostate cancer and non-melanoma skin cancer
Descrição

Cancer Other | Exception Prostate carcinoma | Exception Skin carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
Descrição

Mental disorders Exclude Informed Consent | Impaired cognition Excludes Informed Consent | Mental disorder Study Subject Participation Status Excluded | Impaired cognition Study Subject Participation Status Excluded | Psychiatric symptom Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C0338656
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0233401
UMLS CUI [5,2]
C0332121
for partners/close allies:
Descrição

Partner

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0682323
significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
Descrição

Mental disorders Exclude Informed Consent | Impaired cognition Excludes Informed Consent | Mental disorder Study Subject Participation Status Excluded | Impaired cognition Study Subject Participation Status Excluded | Psychiatric symptom Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C0338656
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0233401
UMLS CUI [5,2]
C0332121
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Similar models

Eligibility Low Risk Prostate Cancer NCT01877070

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Patients
Item
for patients:
boolean
C0030705 (UMLS CUI [1])
Gender Fulfill NCCN Guidelines | Low risk Prostate carcinoma
Item
men who meet the nccn guidelines for low risk prostate cancer, which include all of the following:
boolean
C0079399 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1513893 (UMLS CUI [1,3])
C0162791 (UMLS CUI [1,4])
C5201228 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
Gleason score | TNM clinical staging
Item
most recent gleason score ≤ 6, or clinical stage t1a or less;
boolean
C3203027 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Prostate specific antigen measurement
Item
most recent psa level below 10;
boolean
C0201544 (UMLS CUI [1])
Core needle biopsy Positive Quantity | Malignant Neoplasm Percentage
Item
in the most recent biopsy, had fewer than 3 positive biopsy cores (with ≤ 50% cancer in each); or the patient's doctor discussed active surveillance as a treatment option (as documented in visit notes of the patient's medical record)
boolean
C1318309 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Able to speak English Language | Able to read English Language | Able to write English Language | Comprehension English Language | Informed Consent | Protocol Compliance
Item
are able to speak, read, write and understand english well enough to provide informed consent and complete study tasks
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
C0233733 (UMLS CUI [4,1])
C0376245 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5])
C0525058 (UMLS CUI [6])
Absence Decision Making Treatment
Item
has not made a treatment decision prior to consent, as per self report
boolean
C0332197 (UMLS CUI [1,1])
C0011109 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Partner
Item
for partners/close allies:
boolean
C0682323 (UMLS CUI [1])
Partner Decision Making Treatment
Item
considered a partner/close ally to the patient in the treatment making decision, as reported by the patient
boolean
C0682323 (UMLS CUI [1,1])
C0011109 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Able to speak English Language | Able to read English Language | Able to write English Language | Comprehension English Language | Informed Consent | Protocol Compliance
Item
are able to speak, read, write and understand english well enough to provide informed consent and complete study tasks
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
C0233733 (UMLS CUI [4,1])
C0376245 (UMLS CUI [4,2])
C0021430 (UMLS CUI [5])
C0525058 (UMLS CUI [6])
Age
Item
18 years old or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients
Item
for patients:
boolean
C0030705 (UMLS CUI [1])
Cancer Other | Exception Prostate carcinoma | Exception Skin carcinoma
Item
history of a cancer other than prostate cancer and non-melanoma skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Mental disorders Exclude Informed Consent | Impaired cognition Excludes Informed Consent | Mental disorder Study Subject Participation Status Excluded | Impaired cognition Study Subject Participation Status Excluded | Psychiatric symptom Treatment required for
Item
significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0338656 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0233401 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
Partner
Item
for partners/close allies:
boolean
C0682323 (UMLS CUI [1])
Mental disorders Exclude Informed Consent | Impaired cognition Excludes Informed Consent | Mental disorder Study Subject Participation Status Excluded | Impaired cognition Study Subject Participation Status Excluded | Psychiatric symptom Treatment required for
Item
significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0338656 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0233401 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
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