ID

19705

Description

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

Lien

https://clinicaltrials.gov/show/NCT00519545

Mots-clés

Versions (1)
  1. 23-01-17 23-01-17 -
Téléchargé le

23 januari 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00519545

Anglais

Eligibility Breast Neoplasms NCT00519545

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

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

Breast Carcinoma Primary TNM clinical staging

Type de données

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.
Description

Breast Carcinoma initial diagnosis

Type de données

boolean

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

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy

Type de données

boolean

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

Life Expectancy

Type de données

boolean

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

ECOG performance status

Type de données

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.
Description

Informed Consent

Type de données

boolean

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

Telephone follow-up Monthly Compliance

Type de données

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.
Description

Questionnaires Completion

Type de données

boolean

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

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

Type de données

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
Description

Exclusion Criteria

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

Chemotherapy | Therapeutic radiology procedure

Type de données

boolean

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

Chemotherapy Time last dose | Therapeutic radiology procedure Time last dose

Type de données

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
Description

Breast Carcinoma disease length

Type de données

boolean

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

Age

Type de données

boolean

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

Condition Life Threatening | Condition Severe

Type de données

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.
Description

Diabetic - poor control

Type de données

boolean

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

Heart Disease Severe

Type de données

boolean

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

Liver disease Severe | Lung disease Severe

Type de données

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.
Description

Tobacco use

Type de données

boolean

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

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

Type de données

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.
Description

Missed appointment | Compliance behavior Limited

Type de données

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.
Description

Questionnaire Completion Unable

Type de données

boolean

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

Access to telephone Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C1822200
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Breast Neoplasms NCT00519545

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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