ID

35071

Description

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

Keywords

Versions (1)
  1. 2/13/19 2/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02495155

English

Eligibility Breast Cancer NCT02495155

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

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

Invasive carcinoma of breast TNM Breast tumor staging

Data type

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.
Description

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

Data type

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.
Description

trastuzumab | Antihormone Therapy

Data type

boolean

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

Criteria Fulfill

Data type

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)
Description

Fatigue Fatigue Severity Scale

Data type

boolean

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

Sleeplessness

Data type

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)
Description

Pain Numeric Pain Scale

Data type

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.
Description

Access Computer | Use of Computer | Access Internet

Data type

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.
Description

Able to read English Language | Comprehension English Language

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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