ID

35071

Beschrijving

Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02495155

Link

https://clinicaltrials.gov/show/NCT02495155

Trefwoorden

Versies (1)
  1. 13-02-19 13-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02495155

Engels

Eligibility Breast Cancer NCT02495155

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
stage 0-iii invasive carcinoma of the breast
Beschrijving

Invasive carcinoma of breast TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
Beschrijving

Excision | Assessment Axillary | Therapeutic radiology procedure Completed | Chemotherapy Completed

Datatype

boolean

Alias
UMLS CUI [1]
C0728940
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0004454
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0205197
concomitant trastuzumab and anti-endocrine therapies are permitted. if taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
Beschrijving

trastuzumab | Antihormone Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2]
C2986607
must report at least one of the following:
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
Beschrijving

Fatigue Fatigue Severity Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C3813323
2. insomnia in the week prior to enrollment
Beschrijving

Sleeplessness

Datatype

boolean

Alias
UMLS CUI [1]
C0917801
3. pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
Beschrijving

Pain Numeric Pain Scale

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1518471
has access to and is able to operate a computer with internet access.
Beschrijving

Access Computer | Use of Computer | Access Internet

Datatype

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0009622
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0009622
UMLS CUI [3,1]
C0444454
UMLS CUI [3,2]
C0282111
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
willing and able to sign an informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
Beschrijving

Sleep Apnea Syndrome Interferes with Sleep | Restless Legs Syndrome Interferes with Sleep

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037315
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0037313
UMLS CUI [2,1]
C0035258
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0037313
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Similar models

Eligibility Breast Cancer NCT02495155

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast TNM Breast tumor staging
Item
stage 0-iii invasive carcinoma of the breast
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Excision | Assessment Axillary | Therapeutic radiology procedure Completed | Chemotherapy Completed
Item
surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
boolean
C0728940 (UMLS CUI [1])
C1516048 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
trastuzumab | Antihormone Therapy
Item
concomitant trastuzumab and anti-endocrine therapies are permitted. if taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
boolean
C0728747 (UMLS CUI [1])
C2986607 (UMLS CUI [2])
Criteria Fulfill
Item
must report at least one of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Fatigue Fatigue Severity Scale
Item
1. fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
boolean
C0015672 (UMLS CUI [1,1])
C3813323 (UMLS CUI [1,2])
Sleeplessness
Item
2. insomnia in the week prior to enrollment
boolean
C0917801 (UMLS CUI [1])
Pain Numeric Pain Scale
Item
3. pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
boolean
C0030193 (UMLS CUI [1,1])
C1518471 (UMLS CUI [1,2])
Access Computer | Use of Computer | Access Internet
Item
has access to and is able to operate a computer with internet access.
boolean
C0444454 (UMLS CUI [1,1])
C0009622 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0009622 (UMLS CUI [2,2])
C0444454 (UMLS CUI [3,1])
C0282111 (UMLS CUI [3,2])
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])
Informed Consent
Item
willing and able to sign an informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sleep Apnea Syndrome Interferes with Sleep | Restless Legs Syndrome Interferes with Sleep
Item
diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
boolean
C0037315 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0035258 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0037313 (UMLS CUI [2,3])
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