ID

16280

Description

Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY"; ODM derived from: https://clinicaltrials.gov/show/NCT00201890

Link

https://clinicaltrials.gov/show/NCT00201890

Keywords

Versions (1)
  1. 7/9/16 7/9/16 -
Uploaded on

July 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00201890

English

Eligibility Breast Cancer NCT00201890

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm.
Description

Gender | Breast Carcinoma | Edema Upper Extremity Ipsilateral | Upper Extremity Ipsilateral % volume Increase

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
UMLS CUI [3,1]
C0013604
UMLS CUI [3,2]
C1140618
UMLS CUI [3,3]
C0441989
UMLS CUI [4,1]
C1140618
UMLS CUI [4,2]
C0441989
UMLS CUI [4,3]
C1690016
UMLS CUI [4,4]
C0442805
patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. this is to ensure that scheduling difficulties with daily treatments do not arise. patients may be currently taking tamoxifen or similar hormonal treatment.
Description

First line treatment Complete | Adjuvant therapy Complete | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Tamoxifen | Hormone Therapy

Data type

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
UMLS CUI [6]
C0039286
UMLS CUI [7]
C0279025
Exclusion Criteria
Description

Exclusion Criteria

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

Local disease | Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0277565
UMLS CUI [2]
C2939420
history of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.)
Description

Contralateral breast cancer | Operative Surgical Procedures Axilla | Therapeutic radiology procedure | Edema Upper Extremity Bilateral | Edema Volume | Lymphedema

Data type

boolean

Alias
UMLS CUI [1]
C1096616
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0004454
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0013604
UMLS CUI [4,2]
C1140618
UMLS CUI [4,3]
C0238767
UMLS CUI [5,1]
C0013604
UMLS CUI [5,2]
C0449468
UMLS CUI [6]
C0024236
previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. patients are eligible after a simple hysterectomy (+/- oophorectomy).
Description

Operative Surgical Procedures | Lymph Node Dissection Mediastinum | Therapeutic radiology procedure Mediastinum | Lymph Node Dissection Pelvis | Therapeutic radiology procedure Pelvis | Disruption flow Lymphatic | Hysterectomy | Ovariectomy

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0242382
UMLS CUI [2,2]
C0025066
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0025066
UMLS CUI [4,1]
C0242382
UMLS CUI [4,2]
C0030797
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0030797
UMLS CUI [6,1]
C0332453
UMLS CUI [6,2]
C0806140
UMLS CUI [6,3]
C1522604
UMLS CUI [7]
C0020699
UMLS CUI [8]
C0029936
previously undergone massage therapy for arm edema, or has used compression sleeve within the last month.
Description

Massage Therapy Edema Upper Extremity | Compression Sleeve Use

Data type

boolean

Alias
UMLS CUI [1,1]
C3536731
UMLS CUI [1,2]
C0013604
UMLS CUI [1,3]
C1140618
UMLS CUI [2,1]
C0332459
UMLS CUI [2,2]
C0183336
UMLS CUI [2,3]
C1524063
serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up.
Description

Disease Non-Malignant Serious | Kidney Failure | Heart failure | Exclusion Therapeutic procedure Daily | Exclusion Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518371
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0018801
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0332173
UMLS CUI [5,1]
C2828389
UMLS CUI [5,2]
C3274571
patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm.
Description

Medical contraindication Massage | Therapeutic procedure Communicable Diseases | Thrombosis Upper Extremity affected

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024875
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0009450
UMLS CUI [3,1]
C0040053
UMLS CUI [3,2]
C1140618
UMLS CUI [3,3]
C1314939
unable to commence therapy within 7 days of randomization.
Description

Therapeutic procedure Start Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C1299582
psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Description

Mental disorders Exclusion Informed Consent | Substance Dependence Exclusion Informed Consent | Mental disorders Compliance behavior Limited | Substance Dependence Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1321605
UMLS CUI [3,3]
C0439801
UMLS CUI [4,1]
C0038580
UMLS CUI [4,2]
C1321605
UMLS CUI [4,3]
C0439801
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Similar models

Eligibility Breast Cancer NCT00201890

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma | Edema Upper Extremity Ipsilateral | Upper Extremity Ipsilateral % volume Increase
Item
women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0013604 (UMLS CUI [3,1])
C1140618 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
C1140618 (UMLS CUI [4,1])
C0441989 (UMLS CUI [4,2])
C1690016 (UMLS CUI [4,3])
C0442805 (UMLS CUI [4,4])
First line treatment Complete | Adjuvant therapy Complete | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Tamoxifen | Hormone Therapy
Item
patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. this is to ensure that scheduling difficulties with daily treatments do not arise. patients may be currently taking tamoxifen or similar hormonal treatment.
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])
C0039286 (UMLS CUI [6])
C0279025 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Local disease | Metastatic Neoplasm
Item
clinical or radiological evidence of active disease, either local or metastatic.
boolean
C0277565 (UMLS CUI [1])
C2939420 (UMLS CUI [2])
Contralateral breast cancer | Operative Surgical Procedures Axilla | Therapeutic radiology procedure | Edema Upper Extremity Bilateral | Edema Volume | Lymphedema
Item
history of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.)
boolean
C1096616 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3])
C0013604 (UMLS CUI [4,1])
C1140618 (UMLS CUI [4,2])
C0238767 (UMLS CUI [4,3])
C0013604 (UMLS CUI [5,1])
C0449468 (UMLS CUI [5,2])
C0024236 (UMLS CUI [6])
Operative Surgical Procedures | Lymph Node Dissection Mediastinum | Therapeutic radiology procedure Mediastinum | Lymph Node Dissection Pelvis | Therapeutic radiology procedure Pelvis | Disruption flow Lymphatic | Hysterectomy | Ovariectomy
Item
previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. patients are eligible after a simple hysterectomy (+/- oophorectomy).
boolean
C0543467 (UMLS CUI [1])
C0242382 (UMLS CUI [2,1])
C0025066 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0025066 (UMLS CUI [3,2])
C0242382 (UMLS CUI [4,1])
C0030797 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C0030797 (UMLS CUI [5,2])
C0332453 (UMLS CUI [6,1])
C0806140 (UMLS CUI [6,2])
C1522604 (UMLS CUI [6,3])
C0020699 (UMLS CUI [7])
C0029936 (UMLS CUI [8])
Massage Therapy Edema Upper Extremity | Compression Sleeve Use
Item
previously undergone massage therapy for arm edema, or has used compression sleeve within the last month.
boolean
C3536731 (UMLS CUI [1,1])
C0013604 (UMLS CUI [1,2])
C1140618 (UMLS CUI [1,3])
C0332459 (UMLS CUI [2,1])
C0183336 (UMLS CUI [2,2])
C1524063 (UMLS CUI [2,3])
Disease Non-Malignant Serious | Kidney Failure | Heart failure | Exclusion Therapeutic procedure Daily | Exclusion Follow-up
Item
serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up.
boolean
C0012634 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0035078 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C2828389 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
C2828389 (UMLS CUI [5,1])
C3274571 (UMLS CUI [5,2])
Medical contraindication Massage | Therapeutic procedure Communicable Diseases | Thrombosis Upper Extremity affected
Item
patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm.
boolean
C1301624 (UMLS CUI [1,1])
C0024875 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C0040053 (UMLS CUI [3,1])
C1140618 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
Therapeutic procedure Start Unable
Item
unable to commence therapy within 7 days of randomization.
boolean
C0087111 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Mental disorders Exclusion Informed Consent | Substance Dependence Exclusion Informed Consent | Mental disorders Compliance behavior Limited | Substance Dependence Compliance behavior Limited
Item
psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
boolean
C0004936 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0038580 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
C0038580 (UMLS CUI [4,1])
C1321605 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
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