Breast Cancer NCT01275677 Quality of Life - NSABP-B-47 Medical Conditions and Lifestyle Questionnaire Form - Follow-up (Form MCL-F) - 3165236v1.0 - Portal de Modelos de Datos Médicos (MDM-Portal)

ID

9331

Descripción

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

Palabras clave

Clinical Trial

Quality of Life

C50.9

27/8/12 27/8/12 -
11/8/14 11/8/14 - Martin Dugas
9/1/15 9/1/15 - Martin Dugas

Subido en

9 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy

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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 formularios

StudyEvent: NSABP-B-47 Medical Conditions and Lifestyle Questionnaire Form - Follow-up (Form MCL-F)
1. 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)

Header

Descripción

Header

Patient Initials (Last First Middle)

Descripción

Patient Initials

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25191

UMLS CUI-1: C2986440

NCI Thesaurus ObjectClass: C16960

NCI Thesaurus Property: C25536

NSABP Patient ID

Descripción

Patient ID NSABP

Tipo de datos

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

Institution/Affiliate

Descripción

Institution Name

Tipo de datos

text

Alias

NCI Thesaurus ObjectClass: C25454

UMLS CUI-1: C1301943

NCI Thesaurus ObjectClass-2: C21541

NCI Thesaurus Property: C25364

NCI Thesaurus ValueDomain: C25191

NCI Thesaurus ValueDomain-2: C21541

Institution Number

Descripción

Institution Number

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25337

UMLS CUI-1: C1301943

NCI Thesaurus ObjectClass: C21541

UMLS CUI-2: C0805701

NCI Thesaurus Property: C25364

Staff member administering form, Last Name

Descripción

PersonFormAdministrationLastName

Tipo de datos

text

Alias

NCI Thesaurus ObjectClass: C25190

UMLS 2011AA ObjectClass: C0027361

NCI Thesaurus Property: C19464

UMLS 2011AA Property: C0376315

NCI Thesaurus Property-2: C25409

UMLS 2011AA Property-2: C1533734

NCI Thesaurus ValueDomain: C25191

UMLS 2011AA ValueDomain: C1547383

NCI Thesaurus ValueDomain-2: C25551

UMLS 2011AA ValueDomain-2: C1517741

Staff member administering form, first name

Descripción

PersonFormAdministrationFirstName

Tipo de datos

text

Alias

NCI Thesaurus ObjectClass: C25190

UMLS 2011AA ObjectClass: C0027361

NCI Thesaurus Property: C19464

UMLS 2011AA Property: C0376315

NCI Thesaurus Property-2: C25409

UMLS 2011AA Property-2: C1533734

NCI Thesaurus ValueDomain: C25191

UMLS 2011AA ValueDomain: C1547383

NCI Thesaurus ValueDomain-2: C25509

UMLS 2011AA ValueDomain-2: C1279901

Staff Member Administering Form, Phone

Descripción

PersonFormAdministrationPhoneNumber

Tipo de datos

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-2: C25409

UMLS 2011AA Property-2: C1533734

Are data amended (If yes, check the box and circle amended items)

Descripción

Data amended

Tipo de datos

boolean

Alias

NCI Thesaurus ValueDomain: C38148

UMLS CUI-1: C0680532

NCI Thesaurus ObjectClass: C25474

NCI Thesaurus Property: C25416

Yes

Time Point

Descripción

Time Point

This form is being filled out (mark one)

Descripción

CaseReportFormPersonCompleteType

Tipo de datos

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-2: C25250

UMLS 2011AA Property-2: C0205197

By Clinical Staff On Phone With Participant (By clinical staff on phone with participant)

By Patient In Doctor's Office (By participant in doctor's office)

By Participant Not In Doctor's Office (By participant not in doctor's office)

Other (Other)

Time point

Descripción

AssessmentPeriodType

Tipo de datos

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

12 Months Post Randomization (12 months post randomization)

24 Months Post Randomization (24 months post randomization)

36 Months Post Randomization (36 months post randomization)

48 Months Post Randomization (48 months post randomization)

60 Months Post Randomization (60 months post randomization)

Date Questionnaire Completed (Month Day Year)

Descripción

QualityofLifeCompleteAssessmentDate

Tipo de datos

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-2: C25367

Section 2 - Alcohol And Tobacco Usage

Descripción

Section 2 - Alcohol And Tobacco Usage

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

Descripción

AlcoholConsumptionNumber

Tipo de datos

float

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)

Descripción

Smoking history

Tipo de datos

text

Alias

NCI Thesaurus ValueDomain: C25284

UMLS CUI-1: C1519384

NCI Thesaurus ObjectClass: C17934

NCI Thesaurus Property: C18772

No, Not At All (No, not at all)

Yes, Every Day (Yes, every day)

Yes, Some Days (Yes, some days)

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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 formularios

StudyEvent: NSABP-B-47 Medical Conditions and Lifestyle Questionnaire Form - Follow-up (Form MCL-F)
1. 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

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Header Module

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)

QOL Information

Item Group

Time Point

CaseReportFormPersonCompleteType

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)

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)

AssessmentPeriodType

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-2)

SECTION 1 - Lifetime Medical Conditions

Item Group

Section 1 - Lifetime Medical Conditions

ChronicDiseasePresentType

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)

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-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)

SECTION 2 - Alcohol and Tobacco Usage

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)

Smoking history

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)

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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ID

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Link

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Versiones (3)

Subido en

DOI

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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

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