ID

38294

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02187289

Stichworte

Versionen (1)
  1. 08.10.19 08.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Oktober 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT02187289

Englisch

Eligibility Breast Cancer NCT02187289

1 Formulare  
Inclusion Criteria
Beschreibung

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.)
Beschreibung

Breast Carcinoma | Lymphedema Mild | Lymphedema Moderate

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Maintenance therapy Lymphedema

Datentyp

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
Beschreibung

Compression Sleeve Daytime

Datentyp

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)
Beschreibung

Absence Compression Night time

Datentyp

boolean

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

Exclusion Criteria

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

Local disease | Neoplasm Metastasis

Datentyp

boolean

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

Lymphedema of arm Bilateral

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Protocol Compliance Unable | Etiology Patient on vacation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0422297
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT02187289

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video