ID

9048

Description

NSABP B-45 Worksheet for Thyroid Function Monitoring Form Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=64AFECAB-BE8A-0357-E040-BB89AD431986

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=64AFECAB-BE8A-0357-E040-BB89AD431986

Keywords

  1. 8/27/12 8/27/12 -
  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 NCT00914043 On-Study - NSABP B-45 Worksheet for Thyroid Function Monitoring Form - 2847070v1.0

This paper worksheet may be completed to facilitate the entry of Thyroid Function information (TSH) information in NSABP Coordinator Online. Partially completed worksheets may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL

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
Tsh Assessment
Description

Tsh Assessment

Time point (for this report)
Description

AssessmentPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Was TSH assessed at this time point
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C2280
UMLS 2011AA Property
C0040160
NCI Thesaurus Property-2
C64813
UMLS 2011AA Property-2
C0202230
Tsh Assessment1
Description

Tsh Assessment1

Was the patient being treated with sunitinib/placebo at the time of this assessment
Description

AgentPlaceboSunitinibMalateAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C753
UMLS 2011AA Property
C0032042
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C26673
UMLS 2011AA Property-3
C1698963
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the patient being treated with levothyroxine at the time of this assessment
Description

LevothyroxineAgentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C62080
UMLS 2011AA ObjectClass-2
C1881373
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was levothyroxine initiated as a result of this assessment (If no)
Description

LevothyroxineAgentInitiationAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C62080
UMLS 2011AA ObjectClass-2
C1881373
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C47938
UMLS 2011AA Property-2
C1704686
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Levothyroxine Dose (if either question is marked yes)
Description

LevothyroxineAgentDoseAdministeredType

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C62080
UMLS 2011AA ObjectClass-2
C1881373
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify (mg daily)
Description

LevothyroxineAgentDoseAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C62080
UMLS 2011AA ObjectClass-2
C1881373
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C25382
UMLS 2011AA ValueDomain-2
C1521801
Tsh Assessment2
Description

Tsh Assessment2

Date of Assessment (MM DD YYYY)
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
TSH (patient value microIU/mL)
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementOutcomeUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2280
UMLS 2011AA Property-2
C0040160
NCI Thesaurus Property-3
C64813
UMLS 2011AA Property-3
C0202230
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
TSH LLN (microIU/mL)
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C2280
UMLS 2011AA Property
C0040160
NCI Thesaurus Property-2
C64813
UMLS 2011AA Property-2
C0202230
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
TSH ULN (microIU/mL)
Description

LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C2280
UMLS 2011AA Property
C0040160
NCI Thesaurus Property-2
C64813
UMLS 2011AA Property-2
C0202230
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Did the patient receive any systemic anticancer treatment for documented invasive breast cancer recurrence or second primary cancer prior to this Time Point
Description

PriorSystemicTherapyInvasiveBreastCarcinomaSecondaryMalignantNeoplasmAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C4968
UMLS 2011AA Property
C0751623
NCI Thesaurus Property-2
C9245
UMLS 2011AA Property-2
C0853879
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Reason TSH was Assessed at Other Time Point (When Other Time Point applies)
Description

ThyrotropinMeasurementOtherTimepointAssessmentReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C64813
UMLS 2011AA ObjectClass
C0202230
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25367
NCI Thesaurus Property-3
C68568
UMLS 2011AA Property-2
C2348792
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Description

ThyrotropinMeasurementOtherTimepointAssessmentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C64813
UMLS 2011AA ObjectClass
C0202230
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25367
NCI Thesaurus Property-3
C68568
UMLS 2011AA Property-2
C2348792
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
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

Similar models

This paper worksheet may be completed to facilitate the entry of Thyroid Function information (TSH) information in NSABP Coordinator Online. Partially completed worksheets 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
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
Tsh Assessment
Item
Time point (for this report)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
Code List
Time point (for this report)
CL Item
6 Weeks After Start Of Study Therapy (6 weeks after start of study therapy)
CL Item
3 Months After Randomization (3 months after randomization)
CL Item
6 Months After Randomization (6 months after randomization)
CL Item
9 Months After Randomization (9 months after randomization)
CL Item
12 Months After Randomization (12 months after randomization)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementInd-2
Item
Was TSH assessed at this time point
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C2280 (NCI Thesaurus Property)
C0040160 (UMLS 2011AA Property)
C64813 (NCI Thesaurus Property-2)
C0202230 (UMLS 2011AA Property-2)
Item Group
Tsh Assessment1
AgentPlaceboSunitinibMalateAdministeredInd-2
Item
Was the patient being treated with sunitinib/placebo at the time of this assessment
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C753 (NCI Thesaurus Property)
C0032042 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C26673 (NCI Thesaurus Property-3)
C1698963 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LevothyroxineAgentAdministeredInd-2
Item
Was the patient being treated with levothyroxine at the time of this assessment
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C62080 (NCI Thesaurus ObjectClass-2)
C1881373 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
LevothyroxineAgentInitiationAdministeredInd-2
Item
Was levothyroxine initiated as a result of this assessment (If no)
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C62080 (NCI Thesaurus ObjectClass-2)
C1881373 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C47938 (NCI Thesaurus Property-2)
C1704686 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Levothyroxine Dose (if either question is marked yes)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C62080 (NCI Thesaurus ObjectClass-2)
C1881373 (UMLS 2011AA ObjectClass-2)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Levothyroxine Dose (if either question is marked yes)
CL Item
0.1 Mg Daily (0.1 mg daily)
CL Item
0.125 Mg Daily (0.125 mg daily)
CL Item
0.15 Mg Daily (0.15 mg daily)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LevothyroxineAgentDoseAdministeredSpecify
Item
Other, specify (mg daily)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C62080 (NCI Thesaurus ObjectClass-2)
C1881373 (UMLS 2011AA ObjectClass-2)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus ValueDomain-2)
C1521801 (UMLS 2011AA ValueDomain-2)
Item Group
Tsh Assessment2
Assessment Date
Item
Date of Assessment (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementOutcomeUnspecifiedValue
Item
TSH (patient value microIU/mL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2280 (NCI Thesaurus Property-2)
C0040160 (UMLS 2011AA Property-2)
C64813 (NCI Thesaurus Property-3)
C0202230 (UMLS 2011AA Property-3)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementLowerLimitofNormalValue
Item
TSH LLN (microIU/mL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C2280 (NCI Thesaurus Property)
C0040160 (UMLS 2011AA Property)
C64813 (NCI Thesaurus Property-2)
C0202230 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureThyroidStimulatingHormoneThyrotropinMeasurementUpperLimitofNormalValue
Item
TSH ULN (microIU/mL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C2280 (NCI Thesaurus Property)
C0040160 (UMLS 2011AA Property)
C64813 (NCI Thesaurus Property-2)
C0202230 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
PriorSystemicTherapyInvasiveBreastCarcinomaSecondaryMalignantNeoplasmAdministeredInd-2
Item
Did the patient receive any systemic anticancer treatment for documented invasive breast cancer recurrence or second primary cancer prior to this Time Point
boolean
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C4968 (NCI Thesaurus Property)
C0751623 (UMLS 2011AA Property)
C9245 (NCI Thesaurus Property-2)
C0853879 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Reason TSH was Assessed at Other Time Point (When Other Time Point applies)
text
C64813 (NCI Thesaurus ObjectClass)
C0202230 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C68568 (NCI Thesaurus Property-3)
C2348792 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason TSH was Assessed at Other Time Point (When Other Time Point applies)
CL Item
Evaluation Of Symptoms (Evaluation of Symptoms)
CL Item
Follow-up After Discontinuation Of Levothyroxine (Follow-up after Discontinuation of Levothyroxine)
CL Item
Follow-up Of Previous Assessment (Follow-up of Previous Assessment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ThyrotropinMeasurementOtherTimepointAssessmentSpecify
Item
Other, specify
text
C64813 (NCI Thesaurus ObjectClass)
C0202230 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C68568 (NCI Thesaurus Property-3)
C2348792 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
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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