ID

44026

Description

The Impact of Lymphedema on Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT00769821

Link

https://clinicaltrials.gov/show/NCT00769821

Keywords

Versions (2)
  1. 10/19/17 10/19/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00769821

English

Eligibility Breast Cancer NCT00769821

1 forms  
Criteria
Description

Criteria

diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
no breast cancer on both sides
Description

Bilateral breast cancer Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C2828389
no recurrence of breast cancer (local or distant)
Description

Breast cancer recurrent Local Excluded | Breast cancer recurrent Distant Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C0443203
UMLS CUI [2,3]
C2828389
completed active treatment for breast cancer (i.e., surgery and/or radiotherapy and/or chemotherapy) for ≥ 6 months
Description

Treatment completed Breast Carcinoma | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0392920
no prior contralateral or bilateral mastectomy
Description

Mastectomy Contralateral Excluded | Bilateral mastectomy Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C0441988
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0191877
UMLS CUI [2,2]
C2828389
no pre-existing lymphedema prior to breast cancer diagnosis
Description

Lymphedema Pre-existing Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C2828389
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
weight < 300 pounds
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
mentally and physically able to participate
Description

Intellectual ability Participation | Ability physical Participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0423898
UMLS CUI [1,2]
C0679823
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0205485
UMLS CUI [2,3]
C0679823
no current infection or lymphangitis involving the affected arm
Description

Communicable Disease Excluded | Exclusion Lymphangitis Involving Arm Affected

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2828389
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0024225
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C1140618
UMLS CUI [2,5]
C0392760
no pre-existing neuromuscular conditions that would affect local upper extremity or overall health-related functioning
Description

Exclusion Neuromuscular Diseases Affecting Upper Extremity Local | Exclusion Neuromuscular Diseases Affecting Health

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0027868
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C1140618
UMLS CUI [1,5]
C0205276
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0027868
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0018684
no contraindications to bioimpedance spectroscopy (bis) testing, including the application of electrode adhesive pads to the skin (i.e., unable to lie supine, allergy to electrode adhesive pads, have sunburn, or have open wound)
Description

Exclusion Contraindication Bioimpedance spectroscopy | Unable to lie down Supine | Sunburn | Open wound

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C2958857
UMLS CUI [2,1]
C0560842
UMLS CUI [2,2]
C0038846
UMLS CUI [3]
C0038814
UMLS CUI [4]
C0332798
no contraindications to exercise testing as outlined by the american heart association and the american college of sports medicine
Description

Exclusion Contraindication Exercise testing

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0015260
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.17

Data type

boolean

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Similar models

Eligibility Breast Cancer NCT00769821

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Bilateral breast cancer Excluded
Item
no breast cancer on both sides
boolean
C0281267 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Breast cancer recurrent Local Excluded | Breast cancer recurrent Distant Excluded
Item
no recurrence of breast cancer (local or distant)
boolean
C0278493 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0278493 (UMLS CUI [2,1])
C0443203 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Treatment completed Breast Carcinoma | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy
Item
completed active treatment for breast cancer (i.e., surgery and/or radiotherapy and/or chemotherapy) for ≥ 6 months
boolean
C0580352 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Mastectomy Contralateral Excluded | Bilateral mastectomy Excluded
Item
no prior contralateral or bilateral mastectomy
boolean
C0024881 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0191877 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Lymphedema Pre-existing Excluded
Item
no pre-existing lymphedema prior to breast cancer diagnosis
boolean
C0024236 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Body Weight
Item
weight < 300 pounds
boolean
C0005910 (UMLS CUI [1])
Intellectual ability Participation | Ability physical Participation
Item
mentally and physically able to participate
boolean
C0423898 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0205485 (UMLS CUI [2,2])
C0679823 (UMLS CUI [2,3])
Communicable Disease Excluded | Exclusion Lymphangitis Involving Arm Affected
Item
no current infection or lymphangitis involving the affected arm
boolean
C0009450 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C2828389 (UMLS CUI [2,1])
C0024225 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C1140618 (UMLS CUI [2,4])
C0392760 (UMLS CUI [2,5])
Exclusion Neuromuscular Diseases Affecting Upper Extremity Local | Exclusion Neuromuscular Diseases Affecting Health
Item
no pre-existing neuromuscular conditions that would affect local upper extremity or overall health-related functioning
boolean
C2828389 (UMLS CUI [1,1])
C0027868 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1140618 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,5])
C2828389 (UMLS CUI [2,1])
C0027868 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0018684 (UMLS CUI [2,4])
Exclusion Contraindication Bioimpedance spectroscopy | Unable to lie down Supine | Sunburn | Open wound
Item
no contraindications to bioimpedance spectroscopy (bis) testing, including the application of electrode adhesive pads to the skin (i.e., unable to lie supine, allergy to electrode adhesive pads, have sunburn, or have open wound)
boolean
C2828389 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C2958857 (UMLS CUI [1,3])
C0560842 (UMLS CUI [2,1])
C0038846 (UMLS CUI [2,2])
C0038814 (UMLS CUI [3])
C0332798 (UMLS CUI [4])
Exclusion Contraindication Exercise testing
Item
no contraindications to exercise testing as outlined by the american heart association and the american college of sports medicine
boolean
C2828389 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0015260 (UMLS CUI [1,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.17
Item
see disease characteristics
boolean
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