ID

23480

Beskrivning

Lifestyle Intervention Study in Adjuvant Treatment of Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00463489

Länk

https://clinicaltrials.gov/show/NCT00463489

Nyckelord

Versioner (1)
  1. 2017-07-07 2017-07-07 -
Uppladdad den

7 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00463489

Engelsk

Eligibility Breast Cancer NCT00463489

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
post-menopausal woman with a diagnosis of invasive breast cancer (t1-3,pn0-2,m0) for which definitive surgery was performed during the previous 36 months.
Beskrivning

Postmenopausal state | Invasive carcinoma of breast TNM clinical staging | Operative Surgical Procedures Definitive

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0443196
on adjuvant hormonal therapy with letrozole at time of randomization (either as initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal therapy).
Beskrivning

Hormone Therapy Adjuvant | letrozole | Tamoxifen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [2]
C0246421
UMLS CUI [3]
C0039286
bmi ≥ 24 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
medical, surgical or radiation oncologist agrees to subject participation in a diet and physical activity program.
Beskrivning

Participation Diet therapy Agreement | Participation Physical activity Agreement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0012159
UMLS CUI [1,3]
C4255373
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0026606
UMLS CUI [2,3]
C4255373
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
life expectancy less than five years.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
self-reported inability to walk at least 2 blocks (at any pace).
Beskrivning

Difficulty walking

Datatyp

boolean

Alias
UMLS CUI [1]
C0311394
insulin requiring diabetes (telephone directed diet and physical activity changes would be difficult in this population without close coordination with the treating physician). non-insulin requiring diabetics are eligible for the study.
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diet therapy Difficult | Physical activity Change Difficult | Non-Insulin-Dependent Diabetes Mellitus eligible

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0012159
UMLS CUI [2,2]
C0332218
UMLS CUI [3,1]
C0026606
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0332218
UMLS CUI [4,1]
C0011860
UMLS CUI [4,2]
C1548635
serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
Beskrivning

Digestive problem Serious | Absorption disorder Serious | Inflammatory Bowel Diseases | Chronic diarrhea | Clinical Trial Diet Adherence Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0851121
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1385930
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0021390
UMLS CUI [4]
C0401151
UMLS CUI [5,1]
C0008976
UMLS CUI [5,2]
C0012155
UMLS CUI [5,3]
C1510802
UMLS CUI [5,4]
C2828389
cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
Beskrivning

Cardiovascular Diseases Exclude Physical activity Moderate | Respiration Disorders Exclude Physical activity Moderate | Musculoskeletal Diseases Exclude Physical activity Moderate | Joint problem Excludes Physical activity Moderate | Arthritis Moderate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0026606
UMLS CUI [1,4]
C0205081
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0026606
UMLS CUI [2,4]
C0205081
UMLS CUI [3,1]
C0026857
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0026606
UMLS CUI [3,4]
C0205081
UMLS CUI [4,1]
C0575044
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0026606
UMLS CUI [4,4]
C0205081
UMLS CUI [5,1]
C0003864
UMLS CUI [5,2]
C0205081
psychiatric disorders or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
Beskrivning

Mental disorders Study Subject Participation Status Excluded | Major Depressive Disorder untreated | Psychotic Disorders Major untreated | Substance Use Disorders | Personality Disorders Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0033975
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0332155
UMLS CUI [4]
C0038586
UMLS CUI [5,1]
C0031212
UMLS CUI [5,2]
C0205082
patients on aromatase inhibitors other than letrozole at study entry.
Beskrivning

Aromatase Inhibitors | letrozole

Datatyp

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2]
C0246421
known recurrence of breast cancer (local, regional or distant) at any time prior to study entry.
Beskrivning

Local recurrence of malignant tumor of breast | Breast cancer recurrent regional | Breast cancer recurrent Distant

Datatyp

boolean

Alias
UMLS CUI [1]
C1282471
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C0205147
UMLS CUI [3,1]
C0278493
UMLS CUI [3,2]
C0443203
history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. prior in situ cancer of the breast is not a reason for exclusion.
Beskrivning

Malignant Neoplasms | Skin carcinoma Treated | Curative treatment Carcinoma in situ of uterine cervix | Curative treatment Solid tumour | Disease Free of | Breast Carcinoma In situ

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1273390
UMLS CUI [4,2]
C0280100
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
UMLS CUI [6,1]
C0678222
UMLS CUI [6,2]
C0444498
patients not fluent in either english or french (spoken and written).
Beskrivning

Able to speak fluently English Language | Able to speak fluently French language | Able to write well English Language | Able to write well French language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564241
UMLS CUI [2,2]
C0376246
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0205170
UMLS CUI [3,3]
C0376245
UMLS CUI [4,1]
C0584993
UMLS CUI [4,2]
C0205170
UMLS CUI [4,3]
C0376246
patient unwilling or unable to provide informed consent.
Beskrivning

Informed Consent Unwilling | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Breast Cancer NCT00463489

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Invasive carcinoma of breast TNM clinical staging | Operative Surgical Procedures Definitive
Item
post-menopausal woman with a diagnosis of invasive breast cancer (t1-3,pn0-2,m0) for which definitive surgery was performed during the previous 36 months.
boolean
C0232970 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0443196 (UMLS CUI [3,2])
Hormone Therapy Adjuvant | letrozole | Tamoxifen
Item
on adjuvant hormonal therapy with letrozole at time of randomization (either as initial adjuvant hormonal therapy or after a switch from tamoxifen or other hormonal therapy).
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0246421 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
Body mass index
Item
bmi ≥ 24 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Participation Diet therapy Agreement | Participation Physical activity Agreement
Item
medical, surgical or radiation oncologist agrees to subject participation in a diet and physical activity program.
boolean
C0679823 (UMLS CUI [1,1])
C0012159 (UMLS CUI [1,2])
C4255373 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
C4255373 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Life Expectancy
Item
life expectancy less than five years.
boolean
C0023671 (UMLS CUI [1])
Difficulty walking
Item
self-reported inability to walk at least 2 blocks (at any pace).
boolean
C0311394 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Diet therapy Difficult | Physical activity Change Difficult | Non-Insulin-Dependent Diabetes Mellitus eligible
Item
insulin requiring diabetes (telephone directed diet and physical activity changes would be difficult in this population without close coordination with the treating physician). non-insulin requiring diabetics are eligible for the study.
boolean
C0011854 (UMLS CUI [1])
C0012159 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
C0026606 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C0011860 (UMLS CUI [4,1])
C1548635 (UMLS CUI [4,2])
Digestive problem Serious | Absorption disorder Serious | Inflammatory Bowel Diseases | Chronic diarrhea | Clinical Trial Diet Adherence Excluded
Item
serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
boolean
C0851121 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1385930 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0021390 (UMLS CUI [3])
C0401151 (UMLS CUI [4])
C0008976 (UMLS CUI [5,1])
C0012155 (UMLS CUI [5,2])
C1510802 (UMLS CUI [5,3])
C2828389 (UMLS CUI [5,4])
Cardiovascular Diseases Exclude Physical activity Moderate | Respiration Disorders Exclude Physical activity Moderate | Musculoskeletal Diseases Exclude Physical activity Moderate | Joint problem Excludes Physical activity Moderate | Arthritis Moderate
Item
cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
boolean
C0007222 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0026606 (UMLS CUI [1,3])
C0205081 (UMLS CUI [1,4])
C0035204 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
C0205081 (UMLS CUI [2,4])
C0026857 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0026606 (UMLS CUI [3,3])
C0205081 (UMLS CUI [3,4])
C0575044 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0026606 (UMLS CUI [4,3])
C0205081 (UMLS CUI [4,4])
C0003864 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
Mental disorders Study Subject Participation Status Excluded | Major Depressive Disorder untreated | Psychotic Disorders Major untreated | Substance Use Disorders | Personality Disorders Severe
Item
psychiatric disorders or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
boolean
C0004936 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C1269683 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0033975 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0332155 (UMLS CUI [3,3])
C0038586 (UMLS CUI [4])
C0031212 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Aromatase Inhibitors | letrozole
Item
patients on aromatase inhibitors other than letrozole at study entry.
boolean
C0593802 (UMLS CUI [1])
C0246421 (UMLS CUI [2])
Local recurrence of malignant tumor of breast | Breast cancer recurrent regional | Breast cancer recurrent Distant
Item
known recurrence of breast cancer (local, regional or distant) at any time prior to study entry.
boolean
C1282471 (UMLS CUI [1])
C0278493 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0278493 (UMLS CUI [3,1])
C0443203 (UMLS CUI [3,2])
Malignant Neoplasms | Skin carcinoma Treated | Curative treatment Carcinoma in situ of uterine cervix | Curative treatment Solid tumour | Disease Free of | Breast Carcinoma In situ
Item
history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. prior in situ cancer of the breast is not a reason for exclusion.
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1273390 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1273390 (UMLS CUI [4,1])
C0280100 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C0678222 (UMLS CUI [6,1])
C0444498 (UMLS CUI [6,2])
Able to speak fluently English Language | Able to speak fluently French language | Able to write well English Language | Able to write well French language
Item
patients not fluent in either english or french (spoken and written).
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564241 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0205170 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
C0584993 (UMLS CUI [4,1])
C0205170 (UMLS CUI [4,2])
C0376246 (UMLS CUI [4,3])
Informed Consent Unwilling | Informed Consent Unable
Item
patient unwilling or unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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