ID

21488

Beschrijving

Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection; ODM derived from: https://clinicaltrials.gov/show/NCT00376597

Link

https://clinicaltrials.gov/show/NCT00376597

Trefwoorden

Versies (2)
  1. 24-04-17 24-04-17 -
  2. 24-04-17 24-04-17 -
Geüploaded op

24 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lymphedema NCT00376597

Engels

Eligibility Lymphedema NCT00376597

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphedema NCT00376597
Eligibility Criteria
Beschrijving

Eligibility Criteria

newly diagnosed with stage i-iii cancer of the female breast
Beschrijving

Female Breast Carcinoma TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007104
UMLS CUI [1,2]
C3258246
no prior history of carcinoma in situ, lobular carcinoma in situ (lcis), ductal carcinoma in situ (dcis), or invasive breast cancer
Beschrijving

Carcinoma in Situ Absent | Lobular carcinoma in situ of breast Absent | Noninfiltrating Intraductal Carcinoma Absent | Invasive carcinoma of breast Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007099
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279563
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0007124
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0853879
UMLS CUI [4,2]
C0332197
* patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis; patients with basal cell and squamous cell cancer of the skin are eligible
Beschrijving

Invasive cancer Treatment completed | Basal cell carcinoma | Squamous cell carcinoma of skin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0580352
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
neoadjuvant therapy
Beschrijving

Neoadjuvant Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0600558
patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy
Beschrijving

Radiotherapy to breast | Radiotherapy to axilla | Measurement pre-surgery | Neoadjuvant Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0948310
UMLS CUI [2]
C1997064
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C0441943
UMLS CUI [4]
C0600558
patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy
Beschrijving

Neoadjuvant Chemotherapy | Measurement pre-surgery | Neoadjuvant Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C0242485
UMLS CUI [2,2]
C0441943
UMLS CUI [3]
C0600558
patients receiving no neoadjuvant therapy are eligible
Beschrijving

Neoadjuvant Therapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0332197
may be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; note: patients enrolled on american college of surgeons oncology group (acosog)-z1071 are eligible to participate in this study; patients concurrently enrolled on this study and acosog-z1071, may not also be enrolled on the acosog-z1071 lymphedema sub-study
Beschrijving

Study Subject Participation Status | Operative Surgical Procedures | Excision of axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0193867
no documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
Beschrijving

Conduction disorder of the heart Absent | Unstable Angina Absent | Dementia Absent | Chronic disease Absent | Mortality Increase

Datatype

boolean

Alias
UMLS CUI [1,1]
C0264886
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0497327
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0026565
UMLS CUI [5,2]
C0442805
no diagnosed lymphedema
Beschrijving

Lymphedema Diagnosis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0332197
in order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes
Beschrijving

Sleeve Arm | Arm Measurement | Axilla Measurement | Elbow Measurement | Wrist Measurement | Sleeve size Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0183336
UMLS CUI [1,2]
C1140618
UMLS CUI [2,1]
C1140618
UMLS CUI [2,2]
C0242485
UMLS CUI [3,1]
C0004454
UMLS CUI [3,2]
C0242485
UMLS CUI [4,1]
C0013769
UMLS CUI [4,2]
C0242485
UMLS CUI [5,1]
C0043262
UMLS CUI [5,2]
C0242485
UMLS CUI [6,1]
C0183336
UMLS CUI [6,2]
C0456389
UMLS CUI [6,3]
C1265611
not currently homebound or dependent upon a walker or wheelchair for mobility
Beschrijving

Homebound Absence | Walker Dependent Absence | Wheelchair Dependent Absence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242798
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0043016
UMLS CUI [2,2]
C0851827
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0043143
UMLS CUI [3,2]
C0851827
UMLS CUI [3,3]
C0332197
able to participate in a mild exercise program
Beschrijving

Participation Ability Exercise Mild

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0015259
UMLS CUI [1,4]
C2945599
willing to return to the study site for the duration of the study (18 months)
Beschrijving

Patient Present Study Site

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2825164
sentinel (snd) or full axillary node dissection (and) (no minimum number of nodes required)
Beschrijving

Excision of sentinel lymph node | Excision of axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1]
C2733271
UMLS CUI [2]
C0193867
patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to step 2 are still eligible to remain in the study; however, it should be documented appropriately on form c-1628 at the conclusion of study participation
Beschrijving

Bilateral mastectomy | Excision of axillary lymph nodes | Therapeutic radiology procedure Arm Both | Operative Surgical Procedures Arm Contralateral | Therapeutic radiology procedure Arm Contralateral

Datatype

boolean

Alias
UMLS CUI [1]
C0191877
UMLS CUI [2]
C0193867
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1140618
UMLS CUI [3,3]
C1706086
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C1140618
UMLS CUI [4,3]
C0441988
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C1140618
UMLS CUI [5,3]
C0441988
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Similar models

Eligibility Lymphedema NCT00376597

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Lymphedema NCT00376597
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Female Breast Carcinoma TNM clinical staging
Item
newly diagnosed with stage i-iii cancer of the female breast
boolean
C0007104 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Carcinoma in Situ Absent | Lobular carcinoma in situ of breast Absent | Noninfiltrating Intraductal Carcinoma Absent | Invasive carcinoma of breast Absent
Item
no prior history of carcinoma in situ, lobular carcinoma in situ (lcis), ductal carcinoma in situ (dcis), or invasive breast cancer
boolean
C0007099 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279563 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0007124 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0853879 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Invasive cancer Treatment completed | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
* patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis; patients with basal cell and squamous cell cancer of the skin are eligible
boolean
C0677898 (UMLS CUI [1,1])
C0580352 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
Neoadjuvant Therapy
Item
neoadjuvant therapy
boolean
C0600558 (UMLS CUI [1])
Radiotherapy to breast | Radiotherapy to axilla | Measurement pre-surgery | Neoadjuvant Therapy
Item
patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy
boolean
C0948310 (UMLS CUI [1])
C1997064 (UMLS CUI [2])
C0242485 (UMLS CUI [3,1])
C0441943 (UMLS CUI [3,2])
C0600558 (UMLS CUI [4])
Neoadjuvant Chemotherapy | Measurement pre-surgery | Neoadjuvant Therapy
Item
patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy
boolean
C0600558 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0242485 (UMLS CUI [2,1])
C0441943 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3])
Neoadjuvant Therapy Absent
Item
patients receiving no neoadjuvant therapy are eligible
boolean
C0600558 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Study Subject Participation Status | Operative Surgical Procedures | Excision of axillary lymph nodes
Item
may be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; note: patients enrolled on american college of surgeons oncology group (acosog)-z1071 are eligible to participate in this study; patients concurrently enrolled on this study and acosog-z1071, may not also be enrolled on the acosog-z1071 lymphedema sub-study
boolean
C2348568 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0193867 (UMLS CUI [3])
Conduction disorder of the heart Absent | Unstable Angina Absent | Dementia Absent | Chronic disease Absent | Mortality Increase
Item
no documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
boolean
C0264886 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0497327 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0008679 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0026565 (UMLS CUI [5,1])
C0442805 (UMLS CUI [5,2])
Lymphedema Diagnosis Absent
Item
no diagnosed lymphedema
boolean
C0024236 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Sleeve Arm | Arm Measurement | Axilla Measurement | Elbow Measurement | Wrist Measurement | Sleeve size Quantity
Item
in order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes
boolean
C0183336 (UMLS CUI [1,1])
C1140618 (UMLS CUI [1,2])
C1140618 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C0004454 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C0013769 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C0043262 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
C0183336 (UMLS CUI [6,1])
C0456389 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
Homebound Absence | Walker Dependent Absence | Wheelchair Dependent Absence
Item
not currently homebound or dependent upon a walker or wheelchair for mobility
boolean
C0242798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0043016 (UMLS CUI [2,1])
C0851827 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0043143 (UMLS CUI [3,1])
C0851827 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Participation Ability Exercise Mild
Item
able to participate in a mild exercise program
boolean
C0679823 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C2945599 (UMLS CUI [1,4])
Patient Present Study Site
Item
willing to return to the study site for the duration of the study (18 months)
boolean
C0030705 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Excision of sentinel lymph node | Excision of axillary lymph nodes
Item
sentinel (snd) or full axillary node dissection (and) (no minimum number of nodes required)
boolean
C2733271 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
Bilateral mastectomy | Excision of axillary lymph nodes | Therapeutic radiology procedure Arm Both | Operative Surgical Procedures Arm Contralateral | Therapeutic radiology procedure Arm Contralateral
Item
patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to step 2 are still eligible to remain in the study; however, it should be documented appropriately on form c-1628 at the conclusion of study participation
boolean
C0191877 (UMLS CUI [1])
C0193867 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C1140618 (UMLS CUI [3,2])
C1706086 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C1140618 (UMLS CUI [4,2])
C0441988 (UMLS CUI [4,3])
C1522449 (UMLS CUI [5,1])
C1140618 (UMLS CUI [5,2])
C0441988 (UMLS CUI [5,3])
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