ID

30230

Description

Symptom Burden in Chronic Myeloid Leukemia (CML); ODM derived from: https://clinicaltrials.gov/show/NCT01046305

Link

https://clinicaltrials.gov/show/NCT01046305

Keywords

Versions (1)
  1. 5/22/18 5/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01046305

English

Eligibility Leukemia NCT01046305

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01046305
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 18 years of age or older (patient and family caregiver only)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. ability to speak and read english (all participants)
Description

Able to speak English Language | Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
3. live in the united states (patient phase 3 only)
Description

Residence United States

Data type

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C0041703
4. diagnosis of philadelphia chromosome positive cml confirmed by pathological and cytogenetic analysis (patient only)
Description

Philadelphia chromosome positive chronic myelogenous leukemia Cytogenetic Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0279543
UMLS CUI [1,2]
C0752095
5. being followed at m.d. anderson cancer center (patient only)
Description

Follow-up Cancer Hospital

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0019999
6. consent to participate (all participants)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. treatment for cml for at least 1 year (patient phase 2 only)
Description

Therapeutic procedure CML

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0023473
8. family caregiver also willing to receive packet for expert panel participation (patient phase 2 only)
Description

Family Caregiver Participation Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0086279
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0205369
9. physician or nurse with at least 5 years experience caring for patients with cml (professional expert only)
Description

Specialist Physician CML | Nurse Specialist CML

Data type

boolean

Alias
UMLS CUI [1,1]
C2348234
UMLS CUI [1,2]
C0023473
UMLS CUI [2,1]
C4277711
UMLS CUI [2,2]
C0023473
10. at least one publication in the last 5 years dealing with cml (physician professional expert only)
Description

Publications Quantity | Specialist Physician

Data type

boolean

Alias
UMLS CUI [1,1]
C0034036
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C2348234
11. identification as a family caregiver by a patient with cml (family caregiver only)
Description

Identification Family Caregiver | Patient CML

Data type

boolean

Alias
UMLS CUI [1,1]
C0205396
UMLS CUI [1,2]
C0086279
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0023473
12. patient also willing to receive packet for expert panel participation (family caregiver only)
Description

Patient Participation Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. medical condition or impaired performance status that would preclude participation in the study (patient only)
Description

Medical condition Study Subject Participation Status Excluded | Performance status Impaired Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C1518965
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C0332196
2. diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (patient only)
Description

Psychotic Disorders | Impaired cognition Severe

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0205082
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Similar models

Eligibility Leukemia NCT01046305

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01046305
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. 18 years of age or older (patient and family caregiver only)
boolean
C0001779 (UMLS CUI [1])
Able to speak English Language | Able to read English Language
Item
2. ability to speak and read english (all participants)
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Residence United States
Item
3. live in the united states (patient phase 3 only)
boolean
C0237096 (UMLS CUI [1,1])
C0041703 (UMLS CUI [1,2])
Philadelphia chromosome positive chronic myelogenous leukemia Cytogenetic Analysis
Item
4. diagnosis of philadelphia chromosome positive cml confirmed by pathological and cytogenetic analysis (patient only)
boolean
C0279543 (UMLS CUI [1,1])
C0752095 (UMLS CUI [1,2])
Follow-up Cancer Hospital
Item
5. being followed at m.d. anderson cancer center (patient only)
boolean
C3274571 (UMLS CUI [1,1])
C0019999 (UMLS CUI [1,2])
Informed Consent
Item
6. consent to participate (all participants)
boolean
C0021430 (UMLS CUI [1])
Therapeutic procedure CML
Item
7. treatment for cml for at least 1 year (patient phase 2 only)
boolean
C0087111 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
Family Caregiver Participation Specified
Item
8. family caregiver also willing to receive packet for expert panel participation (patient phase 2 only)
boolean
C0086279 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Specialist Physician CML | Nurse Specialist CML
Item
9. physician or nurse with at least 5 years experience caring for patients with cml (professional expert only)
boolean
C2348234 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C4277711 (UMLS CUI [2,1])
C0023473 (UMLS CUI [2,2])
Publications Quantity | Specialist Physician
Item
10. at least one publication in the last 5 years dealing with cml (physician professional expert only)
boolean
C0034036 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2348234 (UMLS CUI [2])
Identification Family Caregiver | Patient CML
Item
11. identification as a family caregiver by a patient with cml (family caregiver only)
boolean
C0205396 (UMLS CUI [1,1])
C0086279 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0023473 (UMLS CUI [2,2])
Patient Participation Specified
Item
12. patient also willing to receive packet for expert panel participation (family caregiver only)
boolean
C0030705 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Study Subject Participation Status Excluded | Performance status Impaired Study Subject Participation Status Excluded
Item
1. medical condition or impaired performance status that would preclude participation in the study (patient only)
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C1518965 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
Psychotic Disorders | Impaired cognition Severe
Item
2. diagnosis of active psychosis or severe cognitive impairment as determined by primary physician (patient only)
boolean
C0033975 (UMLS CUI [1])
C0338656 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
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