ID

23487

Description

Yoga Study in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00476203

Link

https://clinicaltrials.gov/show/NCT00476203

Keywords

Versions (1)
  1. 7/7/17 7/7/17 -
Uploaded on

July 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00476203

English

Eligibility Breast Cancer NCT00476203

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age 21-75
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with a primary breast cancer stage 0-iiia
Description

Breast Carcinoma Primary TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C3258246
current tamoxifen or aromatase inhibitor use is allowed
Description

Tamoxifen | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0593802
at least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)
Description

Period post treatment | Operative Surgical Procedures Status post | Chemotherapy Status post | Therapeutic radiology procedure Status post

Data type

boolean

Alias
UMLS CUI [1,1]
C1948053
UMLS CUI [1,2]
C2709088
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0231290
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0231290
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0231290
bmi: 24 kg/m2 or greater (if asian or asian-american bmi: 23 kg/m2 or greater)
Description

Body mass index | Asians | Asian Americans

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0078988
UMLS CUI [3]
C0003988
no contraindications to participating in a yoga program
Description

Participation in yoga Medical contraindication Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0454430
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0332197
able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in english
Description

Protocol Compliance | Questionnaires Completion Ability

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0034394
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0085732
gives informed consent, agrees to be randomly assigned
Description

Informed Consent | Random assignment Agreement

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0814868
UMLS CUI [2,2]
C4255373
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
plans to leave the study area within the follow-up period
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
is pregnant or plans to become pregnant during the study period.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
history of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)
Description

Myocardial Infarction | Cerebrovascular accident | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0011849
has practiced yoga more than 1 time per month in the past six months.
Description

Participation in yoga Frequency

Data type

boolean

Alias
UMLS CUI [1,1]
C0454430
UMLS CUI [1,2]
C0439603
current use of medications likely to interfere with adherence to interventions or study outcomes
Description

Pharmaceutical Preparations Interfere with Interventional procedure Adherence | Pharmaceutical Preparations Interfere with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0184661
UMLS CUI [1,4]
C1510802
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
Description

Substance Use Disorders | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
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Similar models

Eligibility Breast Cancer NCT00476203

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 21-75
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma Primary TNM clinical staging
Item
diagnosed with a primary breast cancer stage 0-iiia
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Tamoxifen | Aromatase Inhibitors
Item
current tamoxifen or aromatase inhibitor use is allowed
boolean
C0039286 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Period post treatment | Operative Surgical Procedures Status post | Chemotherapy Status post | Therapeutic radiology procedure Status post
Item
at least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)
boolean
C1948053 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0231290 (UMLS CUI [4,2])
Body mass index | Asians | Asian Americans
Item
bmi: 24 kg/m2 or greater (if asian or asian-american bmi: 23 kg/m2 or greater)
boolean
C1305855 (UMLS CUI [1])
C0078988 (UMLS CUI [2])
C0003988 (UMLS CUI [3])
Participation in yoga Medical contraindication Absent
Item
no contraindications to participating in a yoga program
boolean
C0454430 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Protocol Compliance | Questionnaires Completion Ability
Item
able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in english
boolean
C0525058 (UMLS CUI [1])
C0034394 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Informed Consent | Random assignment Agreement
Item
gives informed consent, agrees to be randomly assigned
boolean
C0021430 (UMLS CUI [1])
C0814868 (UMLS CUI [2,1])
C4255373 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Relocation of home Planned
Item
plans to leave the study area within the follow-up period
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Pregnancy | Pregnancy, Planned
Item
is pregnant or plans to become pregnant during the study period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident | Diabetes Mellitus
Item
history of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
Participation in yoga Frequency
Item
has practiced yoga more than 1 time per month in the past six months.
boolean
C0454430 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Pharmaceutical Preparations Interfere with Interventional procedure Adherence | Pharmaceutical Preparations Interfere with Research results
Item
current use of medications likely to interfere with adherence to interventions or study outcomes
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C1510802 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Substance Use Disorders | Mental disorders
Item
alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
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