ID

44199

Beschrijving

Video Impact on Neulasta Education; ODM derived from: https://clinicaltrials.gov/show/NCT01752907

Link

https://clinicaltrials.gov/show/NCT01752907

Trefwoorden

Versies (2)
  1. 18-09-19 18-09-19 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01752907

Engels

Eligibility Breast Cancer NCT01752907

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or over
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
female with newly diagnosed, not previously treated with chemotherapy, stage i-iii breast cancer
Beschrijving

Gender | Prior Chemotherapy Absent | Breast Carcinoma TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0474926
planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy
Beschrijving

Chemotherapy cycle Adjuvant Quantity Planned | Chemotherapy cycle Neoadjuvant Quantity Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1301732
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1301732
medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and pegfilgrastim as determined by the investigator
Beschrijving

Eligibility Medical Adjuvant Chemotherapy | Eligibility Medical Neoadjuvant Chemotherapy | pegfilgrastim

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0085533
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0205476
UMLS CUI [2,3]
C0600558
UMLS CUI [2,4]
C3665472
UMLS CUI [3]
C1136535
planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the study period
Beschrijving

Prophylactic treatment Planned | pegfilgrastim

Datatype

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C1136535
has provided informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
able to understand the content of the dvd material, in investigator's opinion
Beschrijving

Comprehension DVD Materials

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C4052484
UMLS CUI [1,3]
C0520510
able to read and understand english
Beschrijving

Able to read English Language | Comprehension English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
planning to receive weekly chemotherapy
Beschrijving

Chemotherapy Weekly Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332174
UMLS CUI [1,3]
C1301732
chronic use of oral nsaids or oral antihistamines with the following exception:
Beschrijving

NSAIDs Oral chronic | Antihistamines Oral chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0019590
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205191
chronic oral aspirin use for cardiovascular-related indications
Beschrijving

Exception | Aspirin Oral chronic Cardiovascular Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205191
UMLS CUI [2,4]
C0007222
ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator
Beschrijving

Chronic pain | Condition Painful Treatment required for | Treatment Postoperative Pain | Treatment Post procedural pain

Datatype

boolean

Alias
UMLS CUI [1]
C0150055
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0030193
UMLS CUI [2,3]
C0332121
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0030201
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0877303
chronic oral steroid use. premedication related to the administration of taxanes, and use of anti-emetics is allowed, per usual clinical practice.
Beschrijving

Oral steroid therapy chronic | Premedication Relationship Taxanes allowed | Antiemetics allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0574135
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0033045
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0796419
UMLS CUI [2,4]
C0683607
UMLS CUI [3,1]
C0003297
UMLS CUI [3,2]
C0683607
prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis
Beschrijving

Prior Chemotherapy Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0006826
prior use of g-csf
Beschrijving

G-CSF

Datatype

boolean

Alias
UMLS CUI [1]
C0079459
currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing g-csf (filgrastim, pegfilgrastim, other) or gm-csf (sargramostim) use
Beschrijving

Study Subject Participation Status | G-CSF | Filgrastim | pegfilgrastim | GM-CSF | sargramostim

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0079459
UMLS CUI [3]
C0210630
UMLS CUI [4]
C1136535
UMLS CUI [5]
C0079460
UMLS CUI [6]
C0216231
currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)
Beschrijving

Study Subject Participation Status | Blinded Clinical Study

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2347038
currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage i-iii breast cancer based on nccn clinical practice guidelines in oncology for breast cancer
Beschrijving

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
currently enrolled in, or less than 30 days since ending, any pain intervention study
Beschrijving

Study Subject Participation Status | Pain Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0008976
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Similar models

Eligibility Breast Cancer NCT01752907

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or over
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Gender | Prior Chemotherapy Absent | Breast Carcinoma TNM Breast tumor staging
Item
female with newly diagnosed, not previously treated with chemotherapy, stage i-iii breast cancer
boolean
C0079399 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0678222 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
Chemotherapy cycle Adjuvant Quantity Planned | Chemotherapy cycle Neoadjuvant Quantity Planned
Item
planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy
boolean
C1302181 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C1302181 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1301732 (UMLS CUI [2,4])
Eligibility Medical Adjuvant Chemotherapy | Eligibility Medical Neoadjuvant Chemotherapy | pegfilgrastim
Item
medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and pegfilgrastim as determined by the investigator
boolean
C1548635 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
C1548635 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C3665472 (UMLS CUI [2,4])
C1136535 (UMLS CUI [3])
Prophylactic treatment Planned | pegfilgrastim
Item
planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the study period
boolean
C0199176 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1136535 (UMLS CUI [2])
Informed Consent
Item
has provided informed consent
boolean
C0021430 (UMLS CUI [1])
Comprehension DVD Materials
Item
able to understand the content of the dvd material, in investigator's opinion
boolean
C0162340 (UMLS CUI [1,1])
C4052484 (UMLS CUI [1,2])
C0520510 (UMLS CUI [1,3])
Able to read English Language | Comprehension English Language
Item
able to read and understand english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Weekly Planned
Item
planning to receive weekly chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
NSAIDs Oral chronic | Antihistamines Oral chronic
Item
chronic use of oral nsaids or oral antihistamines with the following exception:
boolean
C0003211 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0019590 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Exception | Aspirin Oral chronic Cardiovascular Diseases
Item
chronic oral aspirin use for cardiovascular-related indications
boolean
C1705847 (UMLS CUI [1])
C0004057 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0007222 (UMLS CUI [2,4])
Chronic pain | Condition Painful Treatment required for | Treatment Postoperative Pain | Treatment Post procedural pain
Item
ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator
boolean
C0150055 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0030193 (UMLS CUI [2,2])
C0332121 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0030201 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0877303 (UMLS CUI [4,2])
Oral steroid therapy chronic | Premedication Relationship Taxanes allowed | Antiemetics allowed
Item
chronic oral steroid use. premedication related to the administration of taxanes, and use of anti-emetics is allowed, per usual clinical practice.
boolean
C0574135 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0033045 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0796419 (UMLS CUI [2,3])
C0683607 (UMLS CUI [2,4])
C0003297 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Prior Chemotherapy Malignant Neoplasms
Item
prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis
boolean
C1514457 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
G-CSF
Item
prior use of g-csf
boolean
C0079459 (UMLS CUI [1])
Study Subject Participation Status | G-CSF | Filgrastim | pegfilgrastim | GM-CSF | sargramostim
Item
currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing g-csf (filgrastim, pegfilgrastim, other) or gm-csf (sargramostim) use
boolean
C2348568 (UMLS CUI [1])
C0079459 (UMLS CUI [2])
C0210630 (UMLS CUI [3])
C1136535 (UMLS CUI [4])
C0079460 (UMLS CUI [5])
C0216231 (UMLS CUI [6])
Study Subject Participation Status | Blinded Clinical Study
Item
currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)
boolean
C2348568 (UMLS CUI [1])
C2347038 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage i-iii breast cancer based on nccn clinical practice guidelines in oncology for breast cancer
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Study Subject Participation Status | Pain Clinical Trial
Item
currently enrolled in, or less than 30 days since ending, any pain intervention study
boolean
C2348568 (UMLS CUI [1])
C0030193 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
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