ID

1090

Description

NSABP-B-47 Medical Conditions and Lifestyle Questionnaire Form - Follow-up (Form MCL-F) 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=96C1751F-BD70-2B10-E040-BB89AD433A9B

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=96C1751F-BD70-2B10-E040-BB89AD433A9B

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 8/11/14 8/11/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

August 27, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 Quality of Life - NSABP-B-47 Medical Conditions and Lifestyle Questionnaire Form - Follow-up (Form MCL-F) - 3165236v1.0

English

INSTRUCTIONS TO THE INSTITUTION This questionnaire should be completed by all patients. Evaluations should be carried out according to schedule, even if the patient discontinues protocol therapy (Patients who experienced breast cancer recurrence, invasive contralateral breast cancer, or second non-breast primary cancer excluding squamous or basal cell skin cancers or new in situ carcinomas of any site do not need to fill out this form [Protocol Section 8.4]) A clinical staff member should complete page 1, print the patient's initials and NSABP Patient ID at the top of Page 2 through 3, and give the questionnaire to the patient for completion. After the patient has completed the questionnaire, verify that the date the questionnaire was completed is recorded at the top of page 2 and fax all 3 pages to the NSABP Biostatistical Center at (412) 622-2115. If all efforts to administer the scheduled MCL-F form fail or if a woman declines to complete the scheduled questionnaire for any reason, a B-47 QMD form should be submitted instead (Protocol Section 8.3.4)

1 forms  
Unnamed1
Description

Unnamed1

Patient Initials (Last First Middle)
Description

PatientInitialsName

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
NSABP Patient ID
Description

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15818
UMLS 2011AA Property
C1513905
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Institution Number
Description

InstitutionIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Staff member administering form, Last Name
Description

PersonFormAdministrationLastName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C25551
UMLS 2011AA ValueDomain
C1517741
Staff member administering form, first name
Description

PersonFormAdministrationFirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
Staff Member Administering Form, Phone
Description

PersonFormAdministrationPhoneNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
Are data amended (If yes, check the box and circle amended items)
Description

DataAmendedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Time Point
Description

Time Point

This form is being filled out (mark one)
Description

CaseReportFormPersonCompleteType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25190
UMLS 2011AA Property
C0027361
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
Time point
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
Date Questionnaire Completed (Month Day Year)
Description

QualityofLifeCompleteAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25367
Section 1 - Lifetime Medical Conditions
Description

Section 1 - Lifetime Medical Conditions

New problem
Description

ChronicDiseasePresentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C14141
UMLS 2011AA ObjectClass
C0205191
Is this a problem for which you have seen a doctor?
Description

DiseaseorDisorderPhysicianCareAssessmentAssessmentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25741
UMLS 2011AA Property
C0031831
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus Property
C61488
UMLS 2011AA Property
C1947933
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Do you currently receive treatment for it?
Description

PatientMedicalConditionTherapyInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25457
UMLS 2011AA Property
C0348080
Does it currently limit your activities?
Description

PersonDiseaseorDisorderActivityRestrictionAssessmentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C43431
UMLS 2011AA Property
C0441655
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C53452
UMLS 2011AA Property
C0443288
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Section 2 - Alcohol And Tobacco Usage
Description

Section 2 - Alcohol And Tobacco Usage

How many drinks of any kind of alcoholic beverage have you had in the last month
Description

AlcoholConsumptionNumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C2190
UMLS 2011AA ObjectClass
C0001962
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Did you use tobacco (In the past month)
Description

SmokingHistoryType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17934
UMLS 2011AA ObjectClass
C0453996
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
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Similar models

INSTRUCTIONS TO THE INSTITUTION This questionnaire should be completed by all patients. Evaluations should be carried out according to schedule, even if the patient discontinues protocol therapy (Patients who experienced breast cancer recurrence, invasive contralateral breast cancer, or second non-breast primary cancer excluding squamous or basal cell skin cancers or new in situ carcinomas of any site do not need to fill out this form [Protocol Section 8.4]) A clinical staff member should complete page 1, print the patient's initials and NSABP Patient ID at the top of Page 2 through 3, and give the questionnaire to the patient for completion. After the patient has completed the questionnaire, verify that the date the questionnaire was completed is recorded at the top of page 2 and fax all 3 pages to the NSABP Biostatistical Center at (412) 622-2115. If all efforts to administer the scheduled MCL-F form fail or if a woman declines to complete the scheduled questionnaire for any reason, a B-47 QMD form should be submitted instead (Protocol Section 8.3.4)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
PatientInitialsName
Item
Patient Initials (Last First 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)
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
InstitutionIdentifierNumber
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PersonFormAdministrationLastName
Item
Staff member administering form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ValueDomain)
C1517741 (UMLS 2011AA ValueDomain)
PersonFormAdministrationFirstName
Item
Staff member administering form, first name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
PersonFormAdministrationPhoneNumber
Item
Staff Member Administering Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
Item
Are data amended (If yes, check the box and circle amended items)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended (If yes, check the box and circle amended items)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Time Point
Item
This form is being filled out (mark one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus Property)
C0027361 (UMLS 2011AA Property)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
CL.2
Code List
This form is being filled out (mark one)
CL Item
By Clinical Staff On Phone With Participant (By clinical staff on phone with participant)
CL Item
By Patient In Doctor's Office (By participant in doctor's office)
CL Item
By Participant Not In Doctor's Office (By participant not in doctor's office)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Time point
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)
CL.3
Code List
Time point
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)
QualityofLifeCompleteAssessmentDate
Item
Date Questionnaire Completed (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property)
Item Group
Section 1 - Lifetime Medical Conditions
Item
New problem
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass)
C0205191 (UMLS 2011AA ObjectClass)
CL.4
Code List
New problem
CL Item
Anemia (Anemia or other blood disease)
E10010 (CTCAE)
CL Item
Atrial Fibrillation (Atrial fibrillation)
E10081 (CTCAE)
CL Item
Back Pain (Back pain)
E12388 (CTCAE)
CL Item
Osteoporosis (Bone loss or osteoporosis)
E12508 (CTCAE)
CL Item
Malignant Neoplasm (Cancer (other than breast or non-melanoma skin cancer))
C9305 (NCI Thesaurus)
C0006826 (UMLS 2011AA)
CL Item
Congestive Heart Failure (Congestive Heart Failure)
C3080 (NCI Thesaurus)
C0018802 (UMLS 2011AA)
CL Item
Depression (Depression)
C2982 (NCI Thesaurus)
C0011570 (UMLS 2011AA)
CL Item
Diabetes Mellitus (Diabetes)
C2985 (NCI Thesaurus)
C0011849 (UMLS 2011AA)
CL Item
Myocardial Infarction (Heart attack (myocardial infarction))
E10152 (CTCAE)
CL Item
Coronary Disease (Heart disease)
C26732 (NCI Thesaurus)
C0010068 (UMLS 2011AA)
CL Item
Hypertension (High blood pressure)
E13785 (CTCAE)
CL Item
Disease Or Disorder Kidney (Kidney disease)
C12415 (NCI Thesaurus)
C0022646 (UMLS 2011AA)
C2991 (NCI Thesaurus)
C0012634 (UMLS 2011AA)
CL Item
Disease Or Disorder Liver (Liver disease)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
C2991 (NCI Thesaurus)
C0012634 (UMLS 2011AA)
CL Item
Disease Or Disorder Pulmonary (Lung disease)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
C2991 (NCI Thesaurus)
C0012634 (UMLS 2011AA)
CL Item
Osteoarthritis (Osteoarthritis, degenerative arthritis)
C3293 (NCI Thesaurus)
C0029408 (UMLS 2011AA)
CL Item
Arrhythmia (Other heart rhythm problem)
C2881 (NCI Thesaurus)
C0003811 (UMLS 2011AA)
CL Item
Rheumatoid Arthritis (Rheumatoid Arthritis)
C2884 (NCI Thesaurus)
C0003873 (UMLS 2011AA)
CL Item
Stroke (Stroke)
E12826 (CTCAE)
CL Item
Disease Or Disorder Thyroid Gland (Thyroid disease)
C12400 (NCI Thesaurus)
C0040132 (UMLS 2011AA)
C2991 (NCI Thesaurus)
C0012634 (UMLS 2011AA)
CL Item
Ulcer (Ulcer or stomach disease)
C3426 (NCI Thesaurus)
C0041582 (UMLS 2011AA)
Item
Is this a problem for which you have seen a doctor?
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus Property)
C0031831 (UMLS 2011AA Property)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C61488 (NCI Thesaurus Property)
C1947933 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.5
Code List
Is this a problem for which you have seen a doctor?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Do you currently receive treatment for it?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property)
C0348080 (UMLS 2011AA Property)
CL.6
Code List
Do you currently receive treatment for it?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Does it currently limit your activities?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C43431 (NCI Thesaurus Property)
C0441655 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C53452 (NCI Thesaurus Property)
C0443288 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.7
Code List
Does it currently limit your activities?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Section 2 - Alcohol And Tobacco Usage
AlcoholConsumptionNumber
Item
How many drinks of any kind of alcoholic beverage have you had in the last month
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Item
Did you use tobacco (In the past month)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.8
Code List
Did you use tobacco (In the past month)
CL Item
No, Not At All (No, not at all)
CL Item
Yes, Every Day (Yes, every day)
CL Item
Yes, Some Days (Yes, some days)
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