ID

38293

Description

The Role of Lifestyle Factors in Breast Cancer-Related Outcomes; ODM derived from: https://clinicaltrials.gov/show/NCT02079662

Link

https://clinicaltrials.gov/show/NCT02079662

Keywords

Versions (1)
  1. 10/8/19 10/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02079662

English

Eligibility Breast Cancer NCT02079662

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women with stage iii breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy.
Description

Breast Carcinoma TNM Breast tumor staging | Therapeutic radiology procedure Course Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C0205539
2. participants must be able to read, write, and speak english.
Description

Able to read English Language | Able to write English Language | Able to speak English Language

Data type

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]
C0564215
UMLS CUI [3,2]
C0376245
3. participants must be at least 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. participants must be oriented to person, place, and time.
Description

Oriented to person, time and place

Data type

boolean

Alias
UMLS CUI [1]
C1961840
5. participants must also meet must also meet at least two of the following criteria related to lifestyle: 1) consume less than 3 servings of fruit and vegetable /day; 2) engage in less than 75 minutes moderate/vigorous activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling); and 3) engage in a mind-body practice less than 4 times a month.
Description

Fruit Serving U/day | Vegetables Serving U/day | Moderate activity Minutes per week | Vigorous activity Minutes per week | Brisk Walking Pace | Bicycling | Mind/body Exercise times per month

Data type

boolean

Alias
UMLS CUI [1,1]
C0016767
UMLS CUI [1,2]
C1519269
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0042440
UMLS CUI [2,2]
C1519269
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C3833417
UMLS CUI [3,2]
C0556975
UMLS CUI [4,1]
C4060778
UMLS CUI [4,2]
C0556975
UMLS CUI [5]
C4289910
UMLS CUI [6]
C0005377
UMLS CUI [7,1]
C2985433
UMLS CUI [7,2]
C0556969
6. participants must have a bmi of 24.45 or higher as assessed in the medical record.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with a recurrent breast cancer diagnosis.
Description

Breast cancer recurrent

Data type

boolean

Alias
UMLS CUI [1]
C0278493
2. patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers.
Description

Cancer Other | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
3. patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia).
Description

Mental disorder Major | Thought disorder Major | Schizophrenia | Bipolar Disorder | Dementia

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C2115875
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0497327
4. patients with communication barriers (e.g., hard of hearing).
Description

Communication Barriers | Hearing Loss, Partial

Data type

boolean

Alias
UMLS CUI [1]
C0009454
UMLS CUI [2]
C0018772
5. patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted).
Description

Impaired mobility Extreme

Data type

boolean

Alias
UMLS CUI [1,1]
C0518456
UMLS CUI [1,2]
C0205403
6. patients with poorly or uncontrolled diabetes in the opinion of the physician(s).
Description

Diabetes mellitus poor control | Diabetes mellitus uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0860161
UMLS CUI [2]
C0421258
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Similar models

Eligibility Breast Cancer NCT02079662

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Therapeutic radiology procedure Course Scheduled
Item
1. women with stage iii breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
Able to read English Language | Able to write English Language | Able to speak English Language
Item
2. participants must be able to read, write, and speak english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0564215 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Age
Item
3. participants must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Oriented to person, time and place
Item
4. participants must be oriented to person, place, and time.
boolean
C1961840 (UMLS CUI [1])
Fruit Serving U/day | Vegetables Serving U/day | Moderate activity Minutes per week | Vigorous activity Minutes per week | Brisk Walking Pace | Bicycling | Mind/body Exercise times per month
Item
5. participants must also meet must also meet at least two of the following criteria related to lifestyle: 1) consume less than 3 servings of fruit and vegetable /day; 2) engage in less than 75 minutes moderate/vigorous activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling); and 3) engage in a mind-body practice less than 4 times a month.
boolean
C0016767 (UMLS CUI [1,1])
C1519269 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0042440 (UMLS CUI [2,1])
C1519269 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C3833417 (UMLS CUI [3,1])
C0556975 (UMLS CUI [3,2])
C4060778 (UMLS CUI [4,1])
C0556975 (UMLS CUI [4,2])
C4289910 (UMLS CUI [5])
C0005377 (UMLS CUI [6])
C2985433 (UMLS CUI [7,1])
C0556969 (UMLS CUI [7,2])
Body mass index
Item
6. participants must have a bmi of 24.45 or higher as assessed in the medical record.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast cancer recurrent
Item
1. patients with a recurrent breast cancer diagnosis.
boolean
C0278493 (UMLS CUI [1])
Cancer Other | Exception Skin carcinoma
Item
2. patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Mental disorder Major | Thought disorder Major | Schizophrenia | Bipolar Disorder | Dementia
Item
3. patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia).
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2115875 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0036341 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0497327 (UMLS CUI [5])
Communication Barriers | Hearing Loss, Partial
Item
4. patients with communication barriers (e.g., hard of hearing).
boolean
C0009454 (UMLS CUI [1])
C0018772 (UMLS CUI [2])
Impaired mobility Extreme
Item
5. patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted).
boolean
C0518456 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
Diabetes mellitus poor control | Diabetes mellitus uncontrolled
Item
6. patients with poorly or uncontrolled diabetes in the opinion of the physician(s).
boolean
C0860161 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
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