ID

38294

Beskrivning

A Study to See Whether Adding Night-time Compression to the Standard Care Will Result in Improved Control of Arm Swelling (Lymphedema) in Breast Cancer Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT02187289

Länk

https://clinicaltrials.gov/show/NCT02187289

Nyckelord

Versioner (1)
  1. 2019-10-08 2019-10-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02187289

Engelsk

Eligibility Breast Cancer NCT02187289

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
Beskrivning

Breast Carcinoma | Lymphedema Mild | Lymphedema Moderate

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0024236
UMLS CUI [2,2]
C2945599
UMLS CUI [3,1]
C0024236
UMLS CUI [3,2]
C0205081
completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
Beskrivning

Cancer treatment Completed | Cancer treatment Adjuvant Completed | Exception Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
in or entering upon the maintenance phase of lymphedema treatment.
Beskrivning

Maintenance therapy Lymphedema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677908
UMLS CUI [1,2]
C0024236
have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
Beskrivning

Compression Sleeve Daytime

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728907
UMLS CUI [1,2]
C0183336
UMLS CUI [1,3]
C0332169
no current use of night-time compression (one month wash-out period before trial entry)
Beskrivning

Absence Compression Night time

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0728907
UMLS CUI [1,3]
C0240526
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical or radiological evidence of active disease, either local or metastatic
Beskrivning

Local disease | Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0277565
UMLS CUI [2]
C0027627
history or clinical diagnosis of bilateral arm lymphedema
Beskrivning

Lymphedema of arm Bilateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0730207
UMLS CUI [1,2]
C0238767
anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
Beskrivning

Medical contraindication Compression | Communicable Disease Untreated | Skin irritation | Exanthema | Thrombosis Arm Affected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728907
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0152030
UMLS CUI [4]
C0015230
UMLS CUI [5,1]
C0040053
UMLS CUI [5,2]
C1140618
UMLS CUI [5,3]
C0392760
serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
Beskrivning

Disease Serious Excludes Informed Consent | Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Disease Serious Excludes Protocol Compliance | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0085281
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0332196
UMLS CUI [4,4]
C0525058
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0085281
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C0525058
unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period
Beskrivning

Protocol Compliance Unable | Etiology Patient on vacation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0422297
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Similar models

Eligibility Breast Cancer NCT02187289

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Lymphedema Mild | Lymphedema Moderate
Item
histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
boolean
C0678222 (UMLS CUI [1])
C0024236 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0024236 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
Cancer treatment Completed | Cancer treatment Adjuvant Completed | Exception Hormone Therapy
Item
completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
boolean
C0920425 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
Maintenance therapy Lymphedema
Item
in or entering upon the maintenance phase of lymphedema treatment.
boolean
C0677908 (UMLS CUI [1,1])
C0024236 (UMLS CUI [1,2])
Compression Sleeve Daytime
Item
have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
boolean
C0728907 (UMLS CUI [1,1])
C0183336 (UMLS CUI [1,2])
C0332169 (UMLS CUI [1,3])
Absence Compression Night time
Item
no current use of night-time compression (one month wash-out period before trial entry)
boolean
C0332197 (UMLS CUI [1,1])
C0728907 (UMLS CUI [1,2])
C0240526 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Local disease | Neoplasm Metastasis
Item
clinical or radiological evidence of active disease, either local or metastatic
boolean
C0277565 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Lymphedema of arm Bilateral
Item
history or clinical diagnosis of bilateral arm lymphedema
boolean
C0730207 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Medical contraindication Compression | Communicable Disease Untreated | Skin irritation | Exanthema | Thrombosis Arm Affected
Item
anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
boolean
C1301624 (UMLS CUI [1,1])
C0728907 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0152030 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C0040053 (UMLS CUI [5,1])
C1140618 (UMLS CUI [5,2])
C0392760 (UMLS CUI [5,3])
Disease Serious Excludes Informed Consent | Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Disease Serious Excludes Protocol Compliance | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance
Item
serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0085281 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0085281 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Protocol Compliance Unable | Etiology Patient on vacation
Item
unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0422297 (UMLS CUI [2,2])
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