ID

26637

Beschrijving

Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT00811824

Link

https://clinicaltrials.gov/show/NCT00811824

Trefwoorden

Versies (2)
  1. 19-10-17 19-10-17 -
  2. 22-10-17 22-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00811824

Engels

Eligibility Breast Cancer NCT00811824

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
21-70 yrs
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
stage 0-iiia breast cancer
Beschrijving

Breast Carcinoma TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
no evidence of recurrent/metastatic disease
Beschrijving

Recurrent disease Absent | Neoplasm Metastasis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
hispanic or african descent (african-american or caribbean)
Beschrijving

Hispanics | African | African American | Caribbean

Datatype

boolean

Alias
UMLS CUI [1]
C0086409
UMLS CUI [2]
C0027567
UMLS CUI [3]
C0085756
UMLS CUI [4]
C1331005
bmi > 25kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
sedentary
Beschrijving

Sedentary

Datatype

boolean

Alias
UMLS CUI [1]
C1532253
completed surgery, chemotherapy, and radiation therapy ≥ 6 months
Beschrijving

Operative Surgical Procedures Completed | Chemotherapy Completed | Therapeutic radiology procedure Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
blood pressure < 140/90
Beschrijving

Blood Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
hgba1c < 8
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
ldl cholesterol < 150
Beschrijving

LDL cholesterol measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202117
no uncontrolled comorbidities
Beschrijving

Comorbidity Uncontrolled Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332197
vo2 max normal ekg changes
Beschrijving

Maximum oxygen uptake Electrocardiographic changes Normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0429693
UMLS CUI [1,2]
C0855329
UMLS CUI [1,3]
C0205307
non-smoker
Beschrijving

Non-smoker

Datatype

boolean

Alias
UMLS CUI [1]
C0337672
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of recurrent or metastatic breast cancer
Beschrijving

Breast cancer recurrent | Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2]
C0346993
uncontrolled co-morbid illness including, but not limited to, type i diabetes mellitus, type ii diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
Beschrijving

Comorbidity Uncontrolled | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hypertensive disease | Symptomatic congestive heart failure | Angina, Unstable | Claudication | Cardiac Arrhythmia | Lung diseases | Hypercholesterolemia | nervous system disorder | Myocardial Ischemia | Heart Diseases | Kidney Diseases | Respiration Disorders | Asthma | Dyspnea | Physical disability | Abnormality of thyroid physiology | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Chemotherapy | Therapeutic radiology procedure | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0011860
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0742758
UMLS CUI [6]
C0002965
UMLS CUI [7]
C1456822
UMLS CUI [8]
C0003811
UMLS CUI [9]
C0024115
UMLS CUI [10]
C0020443
UMLS CUI [11]
C0027765
UMLS CUI [12]
C0151744
UMLS CUI [13]
C0018799
UMLS CUI [14]
C0022658
UMLS CUI [15]
C0035204
UMLS CUI [16]
C0004096
UMLS CUI [17]
C0013404
UMLS CUI [18]
C0520817
UMLS CUI [19]
C0857576
UMLS CUI [20]
C0006826
UMLS CUI [21,1]
C1705847
UMLS CUI [21,2]
C0553723
UMLS CUI [22,1]
C1705847
UMLS CUI [22,2]
C0007117
UMLS CUI [23]
C0392920
UMLS CUI [24]
C1522449
UMLS CUI [25,1]
C0004936
UMLS CUI [25,2]
C0525058
UMLS CUI [25,3]
C0439801
UMLS CUI [26,1]
C0748872
UMLS CUI [26,2]
C0525058
UMLS CUI [26,3]
C0439801
currently taking herceptin therapy, or abnormal echo or muga post-herceptin therapy
Beschrijving

Herceptin | Echocardiogram abnormal Status post Herceptin | MUGA abnormal Status post Herceptin

Datatype

boolean

Alias
UMLS CUI [1]
C0338204
UMLS CUI [2,1]
C0476369
UMLS CUI [2,2]
C0231290
UMLS CUI [2,3]
C0338204
UMLS CUI [3,1]
C0853480
UMLS CUI [3,2]
C0231290
UMLS CUI [3,3]
C0338204
active tobacco use
Beschrijving

Tobacco use

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
currently active in an exercise and/or dietary change weight loss program
Beschrijving

Exercise Program | Dietary change Weight Reduction Program

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C3484370
UMLS CUI [2,1]
C3671772
UMLS CUI [2,2]
C3179079
if a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.
Beschrijving

Development Breast cancer recurrent | Development Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243107
UMLS CUI [1,2]
C0278493
UMLS CUI [2,1]
C0243107
UMLS CUI [2,2]
C0346993
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Similar models

Eligibility Breast Cancer NCT00811824

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
21-70 yrs
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
stage 0-iiia breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Recurrent disease Absent | Neoplasm Metastasis Absent
Item
no evidence of recurrent/metastatic disease
boolean
C0277556 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hispanics | African | African American | Caribbean
Item
hispanic or african descent (african-american or caribbean)
boolean
C0086409 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
C0085756 (UMLS CUI [3])
C1331005 (UMLS CUI [4])
Body mass index
Item
bmi > 25kg/m2
boolean
C1305855 (UMLS CUI [1])
Sedentary
Item
sedentary
boolean
C1532253 (UMLS CUI [1])
Operative Surgical Procedures Completed | Chemotherapy Completed | Therapeutic radiology procedure Completed
Item
completed surgery, chemotherapy, and radiation therapy ≥ 6 months
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Blood Pressure
Item
blood pressure < 140/90
boolean
C0005823 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hgba1c < 8
boolean
C0019018 (UMLS CUI [1])
LDL cholesterol measurement
Item
ldl cholesterol < 150
boolean
C0202117 (UMLS CUI [1])
Comorbidity Uncontrolled Absent
Item
no uncontrolled comorbidities
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Maximum oxygen uptake Electrocardiographic changes Normal
Item
vo2 max normal ekg changes
boolean
C0429693 (UMLS CUI [1,1])
C0855329 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast cancer recurrent | Secondary malignant neoplasm of female breast
Item
evidence of recurrent or metastatic breast cancer
boolean
C0278493 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Comorbidity Uncontrolled | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hypertensive disease | Symptomatic congestive heart failure | Angina, Unstable | Claudication | Cardiac Arrhythmia | Lung diseases | Hypercholesterolemia | nervous system disorder | Myocardial Ischemia | Heart Diseases | Kidney Diseases | Respiration Disorders | Asthma | Dyspnea | Physical disability | Abnormality of thyroid physiology | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Chemotherapy | Therapeutic radiology procedure | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled co-morbid illness including, but not limited to, type i diabetes mellitus, type ii diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0742758 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C1456822 (UMLS CUI [7])
C0003811 (UMLS CUI [8])
C0024115 (UMLS CUI [9])
C0020443 (UMLS CUI [10])
C0027765 (UMLS CUI [11])
C0151744 (UMLS CUI [12])
C0018799 (UMLS CUI [13])
C0022658 (UMLS CUI [14])
C0035204 (UMLS CUI [15])
C0004096 (UMLS CUI [16])
C0013404 (UMLS CUI [17])
C0520817 (UMLS CUI [18])
C0857576 (UMLS CUI [19])
C0006826 (UMLS CUI [20])
C1705847 (UMLS CUI [21,1])
C0553723 (UMLS CUI [21,2])
C1705847 (UMLS CUI [22,1])
C0007117 (UMLS CUI [22,2])
C0392920 (UMLS CUI [23])
C1522449 (UMLS CUI [24])
C0004936 (UMLS CUI [25,1])
C0525058 (UMLS CUI [25,2])
C0439801 (UMLS CUI [25,3])
C0748872 (UMLS CUI [26,1])
C0525058 (UMLS CUI [26,2])
C0439801 (UMLS CUI [26,3])
Herceptin | Echocardiogram abnormal Status post Herceptin | MUGA abnormal Status post Herceptin
Item
currently taking herceptin therapy, or abnormal echo or muga post-herceptin therapy
boolean
C0338204 (UMLS CUI [1])
C0476369 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
C0338204 (UMLS CUI [2,3])
C0853480 (UMLS CUI [3,1])
C0231290 (UMLS CUI [3,2])
C0338204 (UMLS CUI [3,3])
Tobacco use
Item
active tobacco use
boolean
C0543414 (UMLS CUI [1])
Exercise Program | Dietary change Weight Reduction Program
Item
currently active in an exercise and/or dietary change weight loss program
boolean
C0015259 (UMLS CUI [1,1])
C3484370 (UMLS CUI [1,2])
C3671772 (UMLS CUI [2,1])
C3179079 (UMLS CUI [2,2])
Development Breast cancer recurrent | Development Secondary malignant neoplasm of female breast
Item
if a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.
boolean
C0243107 (UMLS CUI [1,1])
C0278493 (UMLS CUI [1,2])
C0243107 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
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