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)

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)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Institution Number
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus 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-2)
C1533734 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)
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-2)
C1533734 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
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-2)
C1533734 (UMLS 2011AA Property-2)
Data amended
Item
Are data amended (If yes, check the box and circle amended items)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
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-2)
C0205197 (UMLS 2011AA Property-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)
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-2)
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-2)
C0205191 (UMLS 2011AA ObjectClass-2)
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-3)
C0012634 (UMLS 2011AA-4)
CL Item
Disease Or Disorder Liver (Liver disease)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
C2991 (NCI Thesaurus-3)
C0012634 (UMLS 2011AA-4)
CL Item
Disease Or Disorder Pulmonary (Lung disease)
C13304 (NCI Thesaurus)
C2709248 (UMLS 2011AA)
C2991 (NCI Thesaurus-3)
C0012634 (UMLS 2011AA-4)
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-3)
C0012634 (UMLS 2011AA-4)
CL Item
Ulcer (Ulcer or stomach disease)
C3426 (NCI Thesaurus)
C0041582 (UMLS 2011AA)
DiseaseorDisorderPhysicianCareAssessmentAssessmentInd-3
Item
Is this a problem for which you have seen a doctor?
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus Property)
C0031831 (UMLS 2011AA Property)
C25217 (NCI Thesaurus Property-2)
C1516048 (UMLS 2011AA Property-2)
C61488 (NCI Thesaurus Property-3)
C1947933 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientMedicalConditionTherapyInd-2
Item
Do you currently receive treatment for it?
boolean
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-2)
C0348080 (UMLS 2011AA Property-2)
PersonDiseaseorDisorderActivityRestrictionAssessmentInd-3
Item
Does it currently limit your activities?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C43431 (NCI Thesaurus Property-2)
C0441655 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C53452 (NCI Thesaurus Property-4)
C0443288 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
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
float
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)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
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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