ID

38257

Beskrivning

Night-time Compression Systems for Breast Cancer Related Lymphedema; ODM derived from: https://clinicaltrials.gov/show/NCT01550250

Länk

https://clinicaltrials.gov/show/NCT01550250

Nyckelord

Versioner (1)
  1. 2019-10-04 2019-10-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01550250

Engelsk

Eligibility Breast Neoplasms NCT01550250

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema).
Beskrivning

Gender | Breast Carcinoma | Edema Arm Ipsilateral | Arm % volume Increase | Lymphedema Mild | Lymphedema Moderate

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3,1]
C0013604
UMLS CUI [3,2]
C1269078
UMLS CUI [3,3]
C0441989
UMLS CUI [4,1]
C1269078
UMLS CUI [4,2]
C1690016
UMLS CUI [4,3]
C0442805
UMLS CUI [5,1]
C0024236
UMLS CUI [5,2]
C2945599
UMLS CUI [6,1]
C0024236
UMLS CUI [6,2]
C0205081
2. patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
Beskrivning

Primary treatment Completed | Adjuvant therapy Completed | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0543467
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1522449
3. patients must have their own fitted compression garment for daytime maintenance.
Beskrivning

Compression garment Daytime Maintenance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985539
UMLS CUI [1,2]
C0332169
UMLS CUI [1,3]
C0024501
4. no past or current use of a night-time compression system for maintenance. those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial.
Beskrivning

Night time Compression System Absent | Night time Compression System Washout Period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0240526
UMLS CUI [1,2]
C0728907
UMLS CUI [1,3]
C0449913
UMLS CUI [1,4]
C0332197
UMLS CUI [2,1]
C0240526
UMLS CUI [2,2]
C0728907
UMLS CUI [2,3]
C0449913
UMLS CUI [2,4]
C1710661
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. 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
2. history of contralateral breast cancer and axillary surgery.
Beskrivning

Contralateral Breast Carcinoma | Operative Surgical Procedure Axillary lymph nodes

Datatyp

boolean

Alias
UMLS CUI [1]
C3274709
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0729594
3. serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
Beskrivning

Disease Serious | Exception Malignant disease | Treatment Daily Excluded | Kidney Failure | Heart failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0442867
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332173
UMLS CUI [3,3]
C0332196
UMLS CUI [4]
C0035078
UMLS CUI [5]
C0018801
4. patients for whom compression is contraindicated.
Beskrivning

Medical contraindication Compression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728907
5. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0085281
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0525058
6. unable to comply with the protocol, measurement and follow-up schedule.
Beskrivning

Protocol Compliance Unable | Compliance Follow-up Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Breast Neoplasms NCT01550250

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma | Edema Arm Ipsilateral | Arm % volume Increase | Lymphedema Mild | Lymphedema Moderate
Item
1. women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 10% and maximum 40% increase in arm volume over the unaffected arm (mild to moderate lymphedema).
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0013604 (UMLS CUI [3,1])
C1269078 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
C1269078 (UMLS CUI [4,1])
C1690016 (UMLS CUI [4,2])
C0442805 (UMLS CUI [4,3])
C0024236 (UMLS CUI [5,1])
C2945599 (UMLS CUI [5,2])
C0024236 (UMLS CUI [6,1])
C0205081 (UMLS CUI [6,2])
Primary treatment Completed | Adjuvant therapy Completed | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure
Item
2. patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization.
boolean
C1708063 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Compression garment Daytime Maintenance
Item
3. patients must have their own fitted compression garment for daytime maintenance.
boolean
C2985539 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
Night time Compression System Absent | Night time Compression System Washout Period
Item
4. no past or current use of a night-time compression system for maintenance. those patients who have trialed a night-time compression system in the past year must observe a six-month washout period before entering the trial.
boolean
C0240526 (UMLS CUI [1,1])
C0728907 (UMLS CUI [1,2])
C0449913 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0240526 (UMLS CUI [2,1])
C0728907 (UMLS CUI [2,2])
C0449913 (UMLS CUI [2,3])
C1710661 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Local disease | Neoplasm Metastasis
Item
1. clinical or radiological evidence of active disease, either local or metastatic.
boolean
C0277565 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
Contralateral Breast Carcinoma | Operative Surgical Procedure Axillary lymph nodes
Item
2. history of contralateral breast cancer and axillary surgery.
boolean
C3274709 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0729594 (UMLS CUI [2,2])
Disease Serious | Exception Malignant disease | Treatment Daily Excluded | Kidney Failure | Heart failure
Item
3. serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow-up.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0442867 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0035078 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
Medical contraindication Compression
Item
4. patients for whom compression is contraindicated.
boolean
C1301624 (UMLS CUI [1,1])
C0728907 (UMLS CUI [1,2])
Mental disorder Excludes Informed Consent | Addictive Behavior Excludes Informed Consent | Mental disorder Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance
Item
5. psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0085281 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Protocol Compliance Unable | Compliance Follow-up Unable
Item
6. unable to comply with the protocol, measurement and follow-up schedule.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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