ID

19705

Beschreibung

Prayer as a Possible Adjuvant Treatment for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00519545

Link

https://clinicaltrials.gov/show/NCT00519545

Stichworte

Versionen (1)
  1. 23.01.17 23.01.17 -
Hochgeladen am

23. Januar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00519545

Englisch

Eligibility Breast Neoplasms NCT00519545

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. primary histological diagnosis of stage i-iv breast cancer.
Beschreibung

Breast Carcinoma Primary TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C3258246
2. initial diagnosis of breast cancer within 5 year of study enrollment.
Beschreibung

Breast Carcinoma initial diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C4071762
3. not currently receiving chemotherapy or radiation therapy. hormone therapy is allowed.
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
4. life expectancy of at least 12 months.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
5. ecog performance status of 0, 1, or 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. willing to sign informed consent indicating that they are aware of the investigational nature of the study and the randomized study design.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
7. willing to comply with monthly follow-up phone calls.
Beschreibung

Telephone follow-up Monthly Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178941
UMLS CUI [1,2]
C0332177
UMLS CUI [1,3]
C3714738
8. willing to complete questionnaires at regular oncology clinic visits.
Beschreibung

Questionnaires Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
9. able to read write & understand english.
Beschreibung

Able to read English Language | Able to write English Language | Comprehension English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. concurrent treatment with chemotherapy or radiation therapy
Beschreibung

Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
2. less than 3 months since last dose of chemotherapy or radiation therapy.
Beschreibung

Chemotherapy Time last dose | Therapeutic radiology procedure Time last dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0946444
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0946444
3. breast cancer diagnosis more than 5 years prior to study enrollment
Beschreibung

Breast Carcinoma disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0872146
4. less than 21 or greater than to 80 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. life threatening or severe concurrent non-malignant conditions.
Beschreibung

Condition Life Threatening | Condition Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205082
6. uncontrolled diabetes mellitus.
Beschreibung

Diabetic - poor control

Datentyp

boolean

Alias
UMLS CUI [1]
C0421258
7. severe heart disease.
Beschreibung

Heart Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
8. severe liver disease. severe lung disease.
Beschreibung

Liver disease Severe | Lung disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205082
9. history of smoking within 5 years of study enrollment.
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
10. psychological or psychiatric disorder that would interfere with study compliance.
Beschreibung

Mental disorder Interferes with Protocol Compliance | Psychological disease Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1658764
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
11. history of missed appointments or poor medical compliance.
Beschreibung

Missed appointment | Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1]
C3854235
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
12. inability to understand instructions on how to complete a questionnaire.
Beschreibung

Questionnaire Completion Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
13. no access to a phone.
Beschreibung

Access to telephone Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1822200
UMLS CUI [1,2]
C0332268
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Ähnliche Modelle

Eligibility Breast Neoplasms NCT00519545

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Primary TNM clinical staging
Item
1. primary histological diagnosis of stage i-iv breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Breast Carcinoma initial diagnosis
Item
2. initial diagnosis of breast cancer within 5 year of study enrollment.
boolean
C0678222 (UMLS CUI [1,1])
C4071762 (UMLS CUI [1,2])
Chemotherapy | Therapeutic radiology procedure | Hormone Therapy
Item
3. not currently receiving chemotherapy or radiation therapy. hormone therapy is allowed.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
Life Expectancy
Item
4. life expectancy of at least 12 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
6. willing to sign informed consent indicating that they are aware of the investigational nature of the study and the randomized study design.
boolean
C0021430 (UMLS CUI [1])
Telephone follow-up Monthly Compliance
Item
7. willing to comply with monthly follow-up phone calls.
boolean
C0178941 (UMLS CUI [1,1])
C0332177 (UMLS CUI [1,2])
C3714738 (UMLS CUI [1,3])
Questionnaires Completion
Item
8. willing to complete questionnaires at regular oncology clinic visits.
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Able to read English Language | Able to write English Language | Comprehension English Language
Item
9. able to read write & understand english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
1. concurrent treatment with chemotherapy or radiation therapy
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Chemotherapy Time last dose | Therapeutic radiology procedure Time last dose
Item
2. less than 3 months since last dose of chemotherapy or radiation therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
Breast Carcinoma disease length
Item
3. breast cancer diagnosis more than 5 years prior to study enrollment
boolean
C0678222 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
4. less than 21 or greater than to 80 years old.
boolean
C0001779 (UMLS CUI [1])
Condition Life Threatening | Condition Severe
Item
5. life threatening or severe concurrent non-malignant conditions.
boolean
C0348080 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Diabetic - poor control
Item
6. uncontrolled diabetes mellitus.
boolean
C0421258 (UMLS CUI [1])
Heart Disease Severe
Item
7. severe heart disease.
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Liver disease Severe | Lung disease Severe
Item
8. severe liver disease. severe lung disease.
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Tobacco use
Item
9. history of smoking within 5 years of study enrollment.
boolean
C0543414 (UMLS CUI [1])
Mental disorder Interferes with Protocol Compliance | Psychological disease Interferes with Protocol Compliance
Item
10. psychological or psychiatric disorder that would interfere with study compliance.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1658764 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Missed appointment | Compliance behavior Limited
Item
11. history of missed appointments or poor medical compliance.
boolean
C3854235 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Questionnaire Completion Unable
Item
12. inability to understand instructions on how to complete a questionnaire.
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Access to telephone Lacking
Item
13. no access to a phone.
boolean
C1822200 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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