ID

35032

Beschrijving

Enhancing Management of Chronic Pain and Symptoms Among Women Treated for Breast Cancer (Lymph-Flow); ODM derived from: https://clinicaltrials.gov/show/NCT02462226

Link

https://clinicaltrials.gov/show/NCT02462226

Trefwoorden

Versies (1)
  1. 11-02-19 11-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02462226

Engels

Eligibility Breast Cancer NCT02462226

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
Beschrijving

Operative Surgical Procedures Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
2. patients who report persistent or intermittent pain, including aching, tenderness, soreness;
Beschrijving

Pain Persistent | Intermittent pain | Aching | Tenderness

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0205322
UMLS CUI [2]
C1282310
UMLS CUI [3]
C0234238
UMLS CUI [4]
C0234233
3. patients may or may not report any of symptoms related to lymphedema (i.e. swelling, heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers);
Beschrijving

Symptoms Lymphedema | Symptoms Absent Lymphedema | Swelling | Heavy feeling | Tightness | Firmness | Numbness | Tingling | Stiffness | Limb Fatigue | Muscle weakness of limb | Limb Mobility Impaired | SHOULDER MOBILITY IMPAIRMENT | Restricted arm mobility | Limited elbow movement | Limited wrist mobility | Decreased finger mobility

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0024236
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0024236
UMLS CUI [3]
C0038999
UMLS CUI [4]
C0581912
UMLS CUI [5]
C0439816
UMLS CUI [6]
C1545487
UMLS CUI [7]
C0028643
UMLS CUI [8]
C2242996
UMLS CUI [9]
C0427008
UMLS CUI [10,1]
C0015385
UMLS CUI [10,2]
C0015672
UMLS CUI [11]
C0587246
UMLS CUI [12,1]
C0015385
UMLS CUI [12,2]
C0425245
UMLS CUI [12,3]
C0221099
UMLS CUI [13]
C0748673
UMLS CUI [14]
C1851132
UMLS CUI [15]
C1849955
UMLS CUI [16]
C1851991
UMLS CUI [17]
C1862133
4. patients may or may not have a history of lymphedema or have been treated for lymphedema.
Beschrijving

Lymphedema | Lymphedema Absent | Lymphedema Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0024236
UMLS CUI [2,1]
C0024236
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0024236
UMLS CUI [3,2]
C1522326
5. patients have internet access to the web-based program at home or willing to access the web-based program using the computer provided by the researchers at the cancer center.
Beschrijving

Internet Access | Use of Web-based application software

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282111
UMLS CUI [1,2]
C0444454
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C3873720
6. ability to understand and the willingness to sign a written informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who do not report any pain, including aching, tenderness, and soreness;
Beschrijving

Pain Absent | Aching Absent | Tenderness Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0234238
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0234233
UMLS CUI [3,2]
C0332197
2. patients who have known metastatic disease or other bulk disease in the thoracic or cervical regions;
Beschrijving

Neoplasm Metastasis Chest | Neoplasm Metastasis Cervical region | Bulky Disease Chest | Bulky Disease Cervical region

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0817096
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0556956
UMLS CUI [3,1]
C1511341
UMLS CUI [3,2]
C0817096
UMLS CUI [4,1]
C1511341
UMLS CUI [4,2]
C0556956
3. patients who have lymphedema due to cancer recurrence.
Beschrijving

Lymphedema Due to Cancer recurrence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024236
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0920420
4. patients with documented advanced cardiac or renal disease.
Beschrijving

Heart Disease Advanced | Kidney Disease Advanced

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205179
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Similar models

Eligibility Breast Cancer NCT02462226

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Operative Surgical Procedures Breast Carcinoma
Item
1. patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Pain Persistent | Intermittent pain | Aching | Tenderness
Item
2. patients who report persistent or intermittent pain, including aching, tenderness, soreness;
boolean
C0030193 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C1282310 (UMLS CUI [2])
C0234238 (UMLS CUI [3])
C0234233 (UMLS CUI [4])
Symptoms Lymphedema | Symptoms Absent Lymphedema | Swelling | Heavy feeling | Tightness | Firmness | Numbness | Tingling | Stiffness | Limb Fatigue | Muscle weakness of limb | Limb Mobility Impaired | SHOULDER MOBILITY IMPAIRMENT | Restricted arm mobility | Limited elbow movement | Limited wrist mobility | Decreased finger mobility
Item
3. patients may or may not report any of symptoms related to lymphedema (i.e. swelling, heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers);
boolean
C1457887 (UMLS CUI [1,1])
C0024236 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024236 (UMLS CUI [2,3])
C0038999 (UMLS CUI [3])
C0581912 (UMLS CUI [4])
C0439816 (UMLS CUI [5])
C1545487 (UMLS CUI [6])
C0028643 (UMLS CUI [7])
C2242996 (UMLS CUI [8])
C0427008 (UMLS CUI [9])
C0015385 (UMLS CUI [10,1])
C0015672 (UMLS CUI [10,2])
C0587246 (UMLS CUI [11])
C0015385 (UMLS CUI [12,1])
C0425245 (UMLS CUI [12,2])
C0221099 (UMLS CUI [12,3])
C0748673 (UMLS CUI [13])
C1851132 (UMLS CUI [14])
C1849955 (UMLS CUI [15])
C1851991 (UMLS CUI [16])
C1862133 (UMLS CUI [17])
Lymphedema | Lymphedema Absent | Lymphedema Treated
Item
4. patients may or may not have a history of lymphedema or have been treated for lymphedema.
boolean
C0024236 (UMLS CUI [1])
C0024236 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024236 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Internet Access | Use of Web-based application software
Item
5. patients have internet access to the web-based program at home or willing to access the web-based program using the computer provided by the researchers at the cancer center.
boolean
C0282111 (UMLS CUI [1,1])
C0444454 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C3873720 (UMLS CUI [2,2])
Informed Consent
Item
6. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pain Absent | Aching Absent | Tenderness Absent
Item
1. patients who do not report any pain, including aching, tenderness, and soreness;
boolean
C0030193 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0234238 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0234233 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Neoplasm Metastasis Chest | Neoplasm Metastasis Cervical region | Bulky Disease Chest | Bulky Disease Cervical region
Item
2. patients who have known metastatic disease or other bulk disease in the thoracic or cervical regions;
boolean
C0027627 (UMLS CUI [1,1])
C0817096 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0556956 (UMLS CUI [2,2])
C1511341 (UMLS CUI [3,1])
C0817096 (UMLS CUI [3,2])
C1511341 (UMLS CUI [4,1])
C0556956 (UMLS CUI [4,2])
Lymphedema Due to Cancer recurrence
Item
3. patients who have lymphedema due to cancer recurrence.
boolean
C0024236 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0920420 (UMLS CUI [1,3])
Heart Disease Advanced | Kidney Disease Advanced
Item
4. patients with documented advanced cardiac or renal disease.
boolean
C0018799 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
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