ID

13907

Descrizione

A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Keywords

Peripheral Blood Stem Cell Transplantation

D016430

Multiple Myeloma

Quality of Life

16/03/16 16/03/16 -

Caricato su

16 marzo 2016

DOI

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Licenza

Creative Commons BY-NC 3.0

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Quality of Life LenaMain-Study

model
Dettagli

No Instruction available.

1 moduli

StudyEvent: AMC-045 Quality of Life Instruments (QLQ)
1. No Instruction available.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

EORTC QLQ-C30 (version 3) Quality of life questionnaire

Item Group

EORTC QLQ-C30 (version 3) Quality of life questionnaire

Physical Activity Difficulty Assessment

Item

Do you have any trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase

integer

C17047 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C17708 (NCI Thesaurus Property-2)
C62189 (NCI Thesaurus Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0518214 (UMLS CUI [1,1])
C0026606 (UMLS CUI [1,2])
C1299586 (UMLS CUI [1,3])

CL.1

Code List

Do you have any trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Long Walking Difficulty Assessment

Item

Do you have any trouble taking a long walk

integer

C17047 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C62189 (NCI Thesaurus Property-2)
C73554 (NCI Thesaurus Property-3)
C25248 (NCI Thesaurus Property-4)
C25664 (NCI Thesaurus ValueDomain)
C0518214 (UMLS CUI [1,1])
C1299586 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0205166 (UMLS CUI [1,4])

CL.2

Code List

Do you have any trouble taking a long walk

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Short Walking Difficulty Assessment

Item

Do you have any trouble taking a short walk outside of the house

integer

C17047 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C62189 (NCI Thesaurus Property-2)
C73554 (NCI Thesaurus Property-3)
C25249 (NCI Thesaurus Property-4)
C25664 (NCI Thesaurus ValueDomain)
C0518214 (UMLS CUI [1,1])
C1299586 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C1806781 (UMLS CUI [1,4])

CL.3

Code List

Do you have any trouble taking a short walk outside of the house

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Bed Rest Assessment

Item

Do you need to stay in bed or a chair during the day

integer

C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C45985 (NCI Thesaurus Property-2)
C0518214 (UMLS CUI [1,1])
C0004910 (UMLS CUI [1,2])
C0425250 (UMLS CUI [1,3])

CL.4

Code List

Do you need to stay in bed or a chair during the day

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Household Activity Support Assessment

Item

Do you need help with eating, dressing, washing yourself or using the toilet

integer

C17047 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C37902 (NCI Thesaurus Property-2)
C53291 (NCI Thesaurus Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0518214 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])

CL.5

Code List

Do you need help with eating, dressing, washing yourself or using the toilet

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

EORTC1 Past Week

Item Group

EORTC1 Past Week

Reduced Occupation Assessment

Item

Were you limited in doing either your work or other daily activities?

integer

C17047 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25640 (NCI Thesaurus Property-2)
C25193 (NCI Thesaurus Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0518214 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])

Reduced Occupation Assessment

Code List

Were you limited in doing either your work or other daily activities?

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Reduced Hobby Assessment

Item

Were you limited in pursuing your hobbies or other leisure time activities?

integer

C17047 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25640 (NCI Thesaurus Property-2)
C73426 (NCI Thesaurus Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0518214 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0019826 (UMLS CUI [1,3])

CL.7

Code List

Were you limited in pursuing your hobbies or other leisure time activities?

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Dyspnea Assessment

Item

Were you short of breath

integer

C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C2998 (NCI Thesaurus ObjectClass-2)
C0031809 (UMLS CUI [1,1])
C0013404 (UMLS CUI [1,2])

CL.8

Code List

Were you short of breath

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Pain Assessment

Item

Have you had pain

integer

C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3303 (NCI Thesaurus ObjectClass-2)
C0031809 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])

CL.9

Code List

Have you had pain

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Need for rest Assessment

Item

Did you need to rest

integer

C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C26754 (NCI Thesaurus ObjectClass-2)
C0031809 (UMLS CUI [1,1])
C0558486 (UMLS CUI [1,2])

CL.10

Code List

Did you need to rest

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

EORTC2 past week

Item Group

Eortc2 past week

Patient Difficulty Sleeping Assessment

Item

Have you had trouble sleeping

integer

C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C73425 (NCI Thesaurus Property-2)
C62189 (NCI Thesaurus Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0037313 (UMLS CUI [1,1])
C1299586 (UMLS CUI [1,2])

Patient Difficulty Sleeping Assessment

Code List

Have you had trouble sleeping

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Weakness Assessment

Item

Have you felt weak

integer

C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3036 (NCI Thesaurus ObjectClass-2)
C0497127 (UMLS CUI [1])

CL.12

Code List

Have you felt weak

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Appetite Assessment

Item

Have you lacked appetite

integer

C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C25152 (NCI Thesaurus ObjectClass-2)
C0003618 (UMLS CUI [1])

CL.13

Code List

Have you lacked appetite

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Nausea Assessment

Item

Have you felt nauseated

integer

C25664 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C3258 (NCI Thesaurus ObjectClass-2)
C0027497 (UMLS CUI [1])

CL.14

Code List

Have you felt nauseated

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Vomiting Assessment

Item

Have you vomited

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C0042963 (UMLS CUI [1])

CL.15

Code List

Have you vomited

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

EORTC3 past week

Item Group

Eortc3 past week

Constipation Assessment

Item

Have you been constipated

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C0009806 (UMLS CUI [1])

CL.16

Code List

Have you been constipated

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Diarrhea Assessment

Item

Have you had diarrhea

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C0011991 (UMLS CUI [1])

CL.17

Code List

Have you had diarrhea

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Tiredness Assessment

Item

Were you tired

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C0848717 (UMLS CUI [1])

CL.18

Code List

Were you tired

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Pain Restricted Quality of Life

Item

Did pain interfere with your daily activities

integer

C16960 (NCI Thesaurus ObjectClass)
CL196329 (NCI Metathesaurus ObjectClass)
C3303 (NCI Thesaurus Property)
CL212559 (NCI Metathesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0030193 (UMLS CUI [1,1])
C0518214 (UMLS CUI [1,2])

CL.19

Code List

Did pain interfere with your daily activities

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Patient Difficulty Concentration

Item

Have you had difficulty in concentrating on things, like reading a newspaper or watching television

integer

C15584 (NCI Thesaurus ObjectClass)
C16960 (NCI Thesaurus Property)
C62189 (NCI Thesaurus Property-2)
C41209 (NCI Thesaurus Property-3)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C1299586 (UMLS CUI [1,1])
C0086045 (UMLS CUI [1,2])
C0518214 (UMLS CUI [1,3])

CL.20

Code List

Have you had difficulty in concentrating on things, like reading a newspaper or watching television

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

EORTC4 past week

Item Group

Eortc4 past week

Nervousness Assessment

Item

Did you feel tense

integer

C16960 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C25584 (NCI Thesaurus Property-2)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0849963 (UMLS CUI [1,1])
C0518214 (UMLS CUI [1,2])

CL.21

Code List

Did you feel tense

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Distress Assessment

Item

Did you worry

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C0815107 (UMLS CUI [1,1])
C0518214 (UMLS CUI [1,2])

CL.22

Code List

Did you worry

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Emotional stability Assessment

Item

Did you feel irritable

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C0237105 (UMLS CUI [1,1])
C0518214 (UMLS CUI [1,2])

CL.23

Code List

Did you feel irritable

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Depression Assessment

Item

Did you feel depressed

integer

C16960 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C2982 (NCI Thesaurus Property-2)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0011570 (UMLS CUI [1,1])
C0518214 (UMLS CUI [1,2])

CL.24

Code List

Did you feel depressed

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Memory Dysfunction Assessment

Item

Have you had difficulty remembering things

integer

C25284 (NCI Thesaurus ValueDomain)
C25755 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ObjectClass)
C46084 (NCI Thesaurus ObjectClass-2)
C0233794 (UMLS CUI [1,1])
C0518214 (UMLS CUI [1,2])

CL.25

Code List

Have you had difficulty remembering things

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

EORTC5 past week

Item Group

Eortc5 past week

Family life Assessment

Item

Has your physical condition or medical treatment interfered with your family life

integer

C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25755 (NCI Thesaurus Property)
C0337640 (UMLS CUI [1,1])
C0518214 (UMLS CUI [1,2])

CL.26

Code List

Has your physical condition or medical treatment interfered with your family life

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Social Activity Assessment

Item

Has your physical condition or medical treatment interfered with your social activities

integer

C15584 (NCI Thesaurus ObjectClass)
C16960 (NCI Thesaurus Property)
C43431 (NCI Thesaurus Property-2)
C3036 (NCI Thesaurus Property-3)
C25664 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0441655 (UMLS CUI [1,1])
C2371613 (UMLS CUI [1,2])
C0518214 (UMLS CUI [1,3])

CL.27

Code List

Has your physical condition or medical treatment interfered with your social activities

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Financial Problems Assessment

Item

Has your physical condition or medical treatment caused you financial difficulties

integer

C25367 (NCI Thesaurus ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25371 (NCI Thesaurus ObjectClass-4)
C25755 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0012634 (UMLS CUI [1,1])
C0680264 (UMLS CUI [1,2])
C0549106 (UMLS CUI [1,3])

CL.28

Code List

Has your physical condition or medical treatment caused you financial difficulties

CL Item

Not at all (1)

CL Item

A little (2)

CL Item

Quite a bit (3)

CL Item

Very much (4)

Overall Patient Health Assessment

Item

How would you rate your overall health during the past week?

integer

C16960 (NCI Thesaurus ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C20989 (NCI Thesaurus Property)
C25178 (NCI Thesaurus Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0030705 (UMLS CUI [1,1])
C0516984 (UMLS CUI [1,2])

CL.29

Code List

How would you rate your overall health during the past week?

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7 (7)

Patient Quality of Life Assessment

Item

How would you rate your overall quality of life during the past week?

integer

C17047 (NCI Thesaurus Property)
C16960 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0518214 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])

CL.30

Code List

How would you rate your overall quality of life during the past week?

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7 (7)

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Caricato su

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Commenti del modello :

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Quality of Life LenaMain-Study

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