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

StudyEvent: NSABP Protocol B-42 - Optional Letrozole Registration Program Worksheet
1. 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.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Registration Information

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)

Eligibility Questions

Item Group

Unnamed2

NSABPPatientClinicalTrialEligibilityCriteriaB-42Type

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)

Adjuvant Hormonal Therapy History

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)

Footer Module

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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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.

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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.