ID

38247

Beskrivning

Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT01302379

Länk

https://clinicaltrials.gov/show/NCT01302379

Nyckelord

Versioner (1)
  1. 2019-10-02 2019-10-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01302379

Engelsk

Eligibility Breast Neoplasms NCT01302379

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
bmi at least 25.0 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
diagnosed with stage i, ii, or iii breast cancer within past 5 years
Beskrivning

Breast Carcinoma TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
Beskrivning

Simple mastectomy | Breast-Conserving Surgery | BREAST CANCER REMOVAL | Negative Surgical Margin macroscopic | Excision of axillary lymph nodes | Radiotherapy to breast Adjuvant

Datatyp

boolean

Alias
UMLS CUI [1]
C0024886
UMLS CUI [2]
C0917927
UMLS CUI [3]
C0741683
UMLS CUI [4,1]
C1709157
UMLS CUI [4,2]
C0439806
UMLS CUI [5]
C0193867
UMLS CUI [6,1]
C0948310
UMLS CUI [6,2]
C1522673
not scheduled for or currently undergoing chemotherapy
Beskrivning

Absence Chemotherapy Scheduled | Chemotherapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
accessible geographically and by telephone
Beskrivning

Patient Available Geographic | Access to telephone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C1517526
UMLS CUI [2]
C1822200
able to communicate dietary and physical activity data via telephone
Beskrivning

Able to communicate Telephone | Data Dietary | Data Physical activity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0039457
UMLS CUI [2,1]
C1511726
UMLS CUI [2,2]
C0012155
UMLS CUI [3,1]
C1511726
UMLS CUI [3,2]
C0026606
if taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
Beskrivning

Statins | Tamoxifen | Aromatase Inhibitors | Treatment Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0360714
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0593802
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0449238
post-menopausal at diagnosis
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
preliminary bloodwork outside of specified ranges
Beskrivning

Hematologic Tests Preliminary Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0439611
UMLS CUI [1,3]
C0205161
evidence of renal insufficiency, liver disease, or congestive heart failure
Beskrivning

Renal Insufficiency | Liver disease | Congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018802
currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
Beskrivning

Adrenal Cortex Hormone Pills | Steroid therapy | ESTROGENS,VAGINAL

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0994475
UMLS CUI [2]
C0149783
UMLS CUI [3]
C1875126
recent initiation (< 3 months ago) of thiazides or β-blockers
Beskrivning

Thiazides Initiation | Adrenergic beta-1 Receptor Antagonists Initiation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0541746
UMLS CUI [1,2]
C1704686
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C1704686
taking insulin or other antidiabetic drug
Beskrivning

Insulin | Antidiabetics

Datatyp

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0935929
other primary or recurrent invasive cancer in past 10 years
Beskrivning

Cancer Other | Invasive cancer Recurrent

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0677898
UMLS CUI [2,2]
C2945760
unable to commit to study requirements
Beskrivning

Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Breast Neoplasms NCT01302379

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
bmi at least 25.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
diagnosed with stage i, ii, or iii breast cancer within past 5 years
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Simple mastectomy | Breast-Conserving Surgery | BREAST CANCER REMOVAL | Negative Surgical Margin macroscopic | Excision of axillary lymph nodes | Radiotherapy to breast Adjuvant
Item
treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
boolean
C0024886 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
C0741683 (UMLS CUI [3])
C1709157 (UMLS CUI [4,1])
C0439806 (UMLS CUI [4,2])
C0193867 (UMLS CUI [5])
C0948310 (UMLS CUI [6,1])
C1522673 (UMLS CUI [6,2])
Absence Chemotherapy Scheduled | Chemotherapy Absent
Item
not scheduled for or currently undergoing chemotherapy
boolean
C0332197 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Patient Available Geographic | Access to telephone
Item
accessible geographically and by telephone
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C1822200 (UMLS CUI [2])
Able to communicate Telephone | Data Dietary | Data Physical activity
Item
able to communicate dietary and physical activity data via telephone
boolean
C2364293 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
C1511726 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
C1511726 (UMLS CUI [3,1])
C0026606 (UMLS CUI [3,2])
Statins | Tamoxifen | Aromatase Inhibitors | Treatment Duration
Item
if taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
boolean
C0360714 (UMLS CUI [1])
C0039286 (UMLS CUI [2])
C0593802 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
Postmenopausal state
Item
post-menopausal at diagnosis
boolean
C0232970 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hematologic Tests Preliminary Abnormal
Item
preliminary bloodwork outside of specified ranges
boolean
C0018941 (UMLS CUI [1,1])
C0439611 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Renal Insufficiency | Liver disease | Congestive heart failure
Item
evidence of renal insufficiency, liver disease, or congestive heart failure
boolean
C1565489 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
Adrenal Cortex Hormone Pills | Steroid therapy | ESTROGENS,VAGINAL
Item
currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
boolean
C0001617 (UMLS CUI [1,1])
C0994475 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2])
C1875126 (UMLS CUI [3])
Thiazides Initiation | Adrenergic beta-1 Receptor Antagonists Initiation
Item
recent initiation (< 3 months ago) of thiazides or β-blockers
boolean
C0541746 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0304516 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
Insulin | Antidiabetics
Item
taking insulin or other antidiabetic drug
boolean
C0021641 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
Cancer Other | Invasive cancer Recurrent
Item
other primary or recurrent invasive cancer in past 10 years
boolean
C1707251 (UMLS CUI [1])
C0677898 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Protocol Compliance Unable
Item
unable to commit to study requirements
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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