ID

8930

Description

NSABP Protocol B-42 - Optional Letrozole Registration Program Worksheet (See Protocol Appendix A) Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF72B9-3E1D-4613-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF72B9-3E1D-4613-E044-0003BA3F9857

Keywords

Versions (2)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00382070 Treatment - NSABP Protocol B-42 - Optional Letrozole Registration Program Worksheet - 2494275v1.0

English

This paper worksheet may be completed to faciliate the entry of the information in NSABP Coordinator Online. Partially completed forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL.

1 forms  
Header
Description

Header

First
Description

Patient Initials First

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C0205435
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25509
Middle
Description

PatientMiddleInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Last
Description

Patient Initials Last

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1517741
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25551
Patient Birth Date
Description

Birth Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0421451
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25155
Site Name
Description

ClinicalTrialSiteNameText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C37901
UMLS 2011AA Property
C0205145
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Patient Social Security Number (USA only)
Description

Social Security Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301821
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25686
Treating physician
Description

TreatingPhysicianName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Unnamed2
Description

Unnamed2

Eligibility Criteria (All must be met)
Description

NSABPPatientClinicalTrialEligibilityCriteriaB-42Type

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C15818
UMLS 2011AA ObjectClass-2
C1513905
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Has the patient authorized the release of Protected Health Information to the NSABP?
Description

PatientPHIConsentIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Adjuvant Hormonal Therapy History
Description

Adjuvant Hormonal Therapy History

Prior aromatase inhibitor therapy (Has patient received AI)
Description

PriorAromataseInhibitorsReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
Aromatase inhibitor treatment start date (If Yes,)
Description

AromataseInhibitorHormoneTherapyAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Cumulative Duration of AIs (# months)
Description

PriorAromataseInhibitorReceivedMonthDuration

Data type

float

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C29846
UMLS 2011AA ValueDomain
C0439231
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Which aromatase inhibitor was most recently being taken (AI)
Description

AromataseInhibitorMostRecentReceivedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
NCI Thesaurus Property-2
C25577
UMLS 2011AA Property-2
C1513491
Did this patient receive any tamoxifen?
Description

PriorTamoxifenAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C855
UMLS 2011AA ObjectClass
C0039286
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Beginning date (If Yes,)
Description

TamoxifenTreatmentBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C855
UMLS 2011AA ObjectClass
C0039286
NCI Thesaurus Property
C15368
Total Duration (# months)
Description

PriorTamoxifenAdministeredMonthDuration

Data type

float

Alias
NCI Thesaurus ObjectClass
C855
UMLS 2011AA ObjectClass
C0039286
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C29846
UMLS 2011AA ValueDomain
C0439231
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Footer Module
Description

Footer Module

Completed by
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date
Description

ResponsiblePersonSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25657
UMLS 2011AA ObjectClass-2
C1273518
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
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Similar models

This paper worksheet may be completed to faciliate the entry of the information in NSABP Coordinator Online. Partially completed forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL.

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials First
Item
First
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleInitialsName
Item
Middle
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Patient Initials Last
Item
Last
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Birth Date
Item
Patient Birth Date
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)
ClinicalTrialSiteNameText
Item
Site Name
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus ObjectClass)
C37901 (NCI Thesaurus Property)
C0205145 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
Social Security Number
Item
Patient Social Security Number (USA only)
text
C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)
TreatingPhysicianName
Item
Treating physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
Item Group
Unnamed2
Item
Eligibility Criteria (All must be met)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15818 (NCI Thesaurus ObjectClass-2)
C1513905 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
CL.1
Code List
Eligibility Criteria (All must be met)
CL Item
Signed And Dated Consent (Signed and Dated Consent)
CL Item
Postmenopausal (Postmenopausal)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
CL Item
Disease-free From Initial Breast Cancer Diagnosis (Disease-free from initial breast cancer diagnosis)
CL Item
Histologically-confirmed Invasive Breast Carcinoma By Diagnostic Core Needle Biopsy Or Final Pathologic Evaluation Of Surgical Specimen (Histologically-confirmed invasive breast carcinoma by diagnostic core needle biopsy or final pathologic evaluation of surgical specimen)
CL Item
Primary Tumor Was Er-positive And/or Pgr-positive (Primary tumor was ER-positive and/or PgR-positive)
CL Item
Lumpectomy + Axillary Staging + Radiation Therapy Or Total Mastectomy + Axillary Staging (Lumpectomy + Axillary Staging + Radiation Therapy OR Total Mastectomy + Axillary Staging)
CL Item
Currently Taking An Aromatase Inhibitor Or Tamoxifen With Cumulative Duration Of 2 - 4.5 Years And With Tamoxifen Duration Of 0-3 Years. (Currently taking an aromatase inhibitor or tamoxifen, and received a duration of 2 - 4.5 years (regardless of missed doses). Total tamoxifen duration must not exceed 3 years.)
CL Item
No History Of Non-traumatic Osteoporotic Bone Fractures (No history of non-traumatic osteoporotic bone fractures)
CL Item
No Diagnosis Of Bilateral Breast Cancer Including Dcis (synchronous Or Metachronous) (No diagnosis of bilateral breast cancer including DCIS (synchronous or metachronous).)
CL Item
Not Currently On Sex Hormonal Therapy (Not currently on sex hormonal therapy)
CL Item
Not On Any Hormonal Agent For Osteoporosis (Not on any hormonal agent for osteoporosis)
CL Item
Not Currently On Any Other Investigational Hormonal Therapy Or In Any Other Hormonal Therapy Clinical Trial (Not currently on any other investigational hormonal therapy or in any other hormonal therapy clinical trial)
CL Item
All Other Protocol Criteria Met (All other protocol criteria met)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientPHIConsentIndicator
Item
Has the patient authorized the release of Protected Health Information to the NSABP?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
Item Group
Adjuvant Hormonal Therapy History
PriorAromataseInhibitorsReceivedInd-2
Item
Prior aromatase inhibitor therapy (Has patient received AI)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
AromataseInhibitorHormoneTherapyAdministeredBeginDate
Item
Aromatase inhibitor treatment start date (If Yes,)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
PriorAromataseInhibitorReceivedMonthDuration
Item
Cumulative Duration of AIs (# months)
float
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C29846 (NCI Thesaurus ValueDomain)
C0439231 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
AromataseInhibitorMostRecentReceivedText
Item
Which aromatase inhibitor was most recently being taken (AI)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)
PriorTamoxifenAdministeredInd-3
Item
Did this patient receive any tamoxifen?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
TamoxifenTreatmentBeginDate
Item
Beginning date (If Yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
PriorTamoxifenAdministeredMonthDuration
Item
Total Duration (# months)
float
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C29846 (NCI Thesaurus ValueDomain)
C0439231 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
Item Group
Footer Module
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
ResponsiblePersonSignatureDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
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