ID

44046

Beschreibung

Participation Restrictions in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT01225328

Link

https://clinicaltrials.gov/show/NCT01225328

Stichworte

Versionen (2)
  1. 30.08.19 30.08.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01225328

Englisch

Eligibility Breast Cancer NCT01225328

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female breast cancer patient stages i-iii.
Beschreibung

Gender | Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0474926
2. age 18-59.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. completion of definitive breast cancer treatment (i.e., subsequent to loco-regional surgical treatment and completion of adjuvant or neo-adjuvant chemotherapy with or without radiation) within the past 3-6 months.
Beschreibung

Treatment completed Breast Carcinoma | Status post Operative Surgical Procedure Local-Regional | Adjuvant Chemotherapy Completed | Neoadjuvant Chemotherapy Completed | Therapeutic radiology procedure | Therapeutic radiology procedure Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C1947913
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C3665472
UMLS CUI [4,3]
C0205197
UMLS CUI [5]
C1522449
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C0332197
4. screen positive for a moderate or worse level of participation restriction (work and social adjustment scale score > 10) within 6 months following cancer treatment.
Beschreibung

Study Subject Participation Status Restricted Moderate | Study Subject Participation Status Restricted Severe | Other Coding | Status post Cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0443288
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0443288
UMLS CUI [2,3]
C0205082
UMLS CUI [3]
C3846158
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0920425
5. english speaking.
Beschreibung

Able to speak English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
6. have a land-based phone or reliable cell phone reception.
Beschreibung

Availability of Telephone | Availability of Cell Phone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0039457
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1136359
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non-correctable hearing loss.
Beschreibung

Hearing loss | Correction Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0011053
UMLS CUI [2,1]
C1947976
UMLS CUI [2,2]
C1272705
2. moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
Beschreibung

Moderate cognitive impairment Cognitive Assessment Score | Severe cognitive impairment Cognitive Assessment Score

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3839816
UMLS CUI [1,2]
C0870300
UMLS CUI [1,3]
C0449820
UMLS CUI [2,1]
C3554639
UMLS CUI [2,2]
C0870300
UMLS CUI [2,3]
C0449820
3. medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder) or active substance abuse.
Beschreibung

Mental Disorders, Severe | Schizophrenia | Bipolar Disorder | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C4046029
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0038586
4. medical record documentation of a physical disorder with associated functional impairment (e.g., parkinson's disease, stroke, congestive heart failure, etc.).
Beschreibung

Physical illness Associated with Functional impairment | Parkinson Disease | Cerebrovascular accident | Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C4062321
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0018802
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Ähnliche Modelle

Eligibility Breast Cancer NCT01225328

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma TNM Breast tumor staging
Item
1. female breast cancer patient stages i-iii.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
Age
Item
2. age 18-59.
boolean
C0001779 (UMLS CUI [1])
Treatment completed Breast Carcinoma | Status post Operative Surgical Procedure Local-Regional | Adjuvant Chemotherapy Completed | Neoadjuvant Chemotherapy Completed | Therapeutic radiology procedure | Therapeutic radiology procedure Absent
Item
3. completion of definitive breast cancer treatment (i.e., subsequent to loco-regional surgical treatment and completion of adjuvant or neo-adjuvant chemotherapy with or without radiation) within the past 3-6 months.
boolean
C0580352 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1947913 (UMLS CUI [2,3])
C0085533 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0600558 (UMLS CUI [4,1])
C3665472 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C1522449 (UMLS CUI [5])
C1522449 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Study Subject Participation Status Restricted Moderate | Study Subject Participation Status Restricted Severe | Other Coding | Status post Cancer treatment
Item
4. screen positive for a moderate or worse level of participation restriction (work and social adjustment scale score > 10) within 6 months following cancer treatment.
boolean
C2348568 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C3846158 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0920425 (UMLS CUI [4,2])
Able to speak English Language
Item
5. english speaking.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Availability of Telephone | Availability of Cell Phone
Item
6. have a land-based phone or reliable cell phone reception.
boolean
C0470187 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1136359 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hearing loss | Correction Unsuccessful
Item
1. non-correctable hearing loss.
boolean
C0011053 (UMLS CUI [1])
C1947976 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Moderate cognitive impairment Cognitive Assessment Score | Severe cognitive impairment Cognitive Assessment Score
Item
2. moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
boolean
C3839816 (UMLS CUI [1,1])
C0870300 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C3554639 (UMLS CUI [2,1])
C0870300 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Mental Disorders, Severe | Schizophrenia | Bipolar Disorder | Substance Use Disorders
Item
3. medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder) or active substance abuse.
boolean
C4046029 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0038586 (UMLS CUI [4])
Physical illness Associated with Functional impairment | Parkinson Disease | Cerebrovascular accident | Congestive heart failure
Item
4. medical record documentation of a physical disorder with associated functional impairment (e.g., parkinson's disease, stroke, congestive heart failure, etc.).
boolean
C0683323 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C4062321 (UMLS CUI [1,3])
C0030567 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
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