ID

9354

Description

NSABP-B-47 Hormonal/Endocrine Therapy Form (Form HT) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95594CE0-B466-936E-E040-BB89AD43333F

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=95594CE0-B466-936E-E040-BB89AD43333F

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 NCT01275677 Treatment - NSABP-B-47 Hormonal/Endocrine Therapy Form (Form HT) - 3161813v1.0

English

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed worksheets may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. This form applies ONLY to women with ER-positive and/or PgR-positive tumors. This form should be submitted through 6 years on study, even if all postoperative adjuvant hormonal treatment is reported to have ended. Do not report hormonal therapy that was taken to treat breast cancer recurrence or second primary cancer

1 forms  
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Unnamed Module 1
Description

Unnamed Module 1

Reporting Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Since being entered on study, has the patient received any postoperative adjuvant hormonal treatment? (If no, omit all remaining questions)
Description

PostoperativeAdjuvantHormoneTherapyPostClinicalStudyEnrollmentReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C28006
UMLS 2011AA ObjectClass
C0032790
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus Property-4
C37948
UMLS 2011AA Property-4
C1516879
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was endocrine therapy use assessed at the specified time point (If yes, complete the following table)
Description

HormoneTherapyReportPeriodAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property-2
C0684224
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Unnamed3
Description

Unnamed3

Agent Name
Description

AgentName

Data type

text

Other, specify
Description

HormoneTherapyAgentAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was agent administered
Description

Agent administered during reporting period

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0450442
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
Cumulative Agent Duration (Round up to the nearest month months)
Description

AgentAdministeredDayDuration

Data type

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Footer
Description

Footer

Comments (optional)
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person Completing Form
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 Form Completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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Similar models

This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed worksheets may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. This form applies ONLY to women with ER-positive and/or PgR-positive tumors. This form should be submitted through 6 years on study, even if all postoperative adjuvant hormonal treatment is reported to have ended. Do not report hormonal therapy that was taken to treat breast cancer recurrence or second primary cancer

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Unnamed Module 1
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
12 Months Post Randomization (12 Months Post Randomization)
CL Item
24 Months Post Randomization (24 Months Post Randomization)
CL Item
36 Months Post Randomization (36 Months Post Randomization)
CL Item
48 Months Post Randomization (48 Months Post Randomization)
CL Item
60 Months Post Randomization (60 Months Post Randomization)
CL Item
72 Months Post Randomization (72 Months Post Randomization)
PostoperativeAdjuvantHormoneTherapyPostClinicalStudyEnrollmentReceivedInd-2
Item
Since being entered on study, has the patient received any postoperative adjuvant hormonal treatment? (If no, omit all remaining questions)
boolean
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C37948 (NCI Thesaurus Property-4)
C1516879 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HormoneTherapyReportPeriodAdministeredInd-3
Item
Was endocrine therapy use assessed at the specified time point (If yes, complete the following table)
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Unnamed3
AgentName
Item
Agent Name
text
HormoneTherapyAgentAdministeredSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Agent administered during reporting period
Item
Was agent administered
boolean
C38147 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
AgentAdministeredDayDuration
Item
Cumulative Agent Duration (Round up to the nearest month months)
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
Item Group
Footer
Research Comments
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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