ID

14860

Description

Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors; ODM derived from: https://clinicaltrials.gov/show/NCT02352779

Link

https://clinicaltrials.gov/show/NCT02352779

Keywords

Versions (2)
  1. 5/2/16 5/2/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

May 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Carcinoma NCT02352779

English

Eligibility Breast Carcinoma NCT02352779

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
Description

Breast Carcinoma | Primary malignant neoplasm Past

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C1306459
UMLS CUI [2,2]
C1444637
have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
Description

Adjuvant therapy Breast Carcinoma | Operative Surgical Procedures | Chemotherapy Regimen | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as herceptin)
Description

Adjuvant therapy Breast Carcinoma completed | Operative Surgical Procedures | Chemotherapy Regimen | Therapeutic radiology procedure | Hormone preparation | Tamoxifen | Monoclonal antibodies, antineoplastic | Herceptin

Data type

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C1556116
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0019928
UMLS CUI [6]
C0039286
UMLS CUI [7]
C3542957
UMLS CUI [8]
C0338204
must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine
Description

Fatigue Malignant Neoplasms | Level of fatigue

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0006826
UMLS CUI [2]
C2586108
be able to read english
Description

Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
able to swallow medication
Description

Able to swallow oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
give written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as lovaza®)
Description

Omega-3 Fatty Acids | Pharmaceutical Preparations Lovaza

Data type

boolean

Alias
UMLS CUI [1]
C0015689
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0912903
be taking anticoagulant medication (does not include aspirin)
Description

Anticoagulants | Aspirin

Data type

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C0004057
have sensitivity or allergy to fish and/or shellfish
Description

Hypersensitivity Fishes | Hypersensitivity Shellfish

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016163
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1304606
have sensitivity or allergy to soy and/or soybeans
Description

Hypersensitivity Soy | Hypersensitivity Soybeans

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2756587
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0037733
have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
Description

Chronic Fatigue Syndrome | Diagnosis Causing Fatigue Severe

Data type

boolean

Alias
UMLS CUI [1]
C0015674
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0015672
UMLS CUI [2,4]
C0205082
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Similar models

Eligibility Breast Carcinoma NCT02352779

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Primary malignant neoplasm Past
Item
have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
boolean
C0678222 (UMLS CUI [1])
C1306459 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
Adjuvant therapy Breast Carcinoma | Operative Surgical Procedures | Chemotherapy Regimen | Therapeutic radiology procedure
Item
have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
boolean
C0677850 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Adjuvant therapy Breast Carcinoma completed | Operative Surgical Procedures | Chemotherapy Regimen | Therapeutic radiology procedure | Hormone preparation | Tamoxifen | Monoclonal antibodies, antineoplastic | Herceptin
Item
have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as herceptin)
boolean
C0677850 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1556116 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0019928 (UMLS CUI [5])
C0039286 (UMLS CUI [6])
C3542957 (UMLS CUI [7])
C0338204 (UMLS CUI [8])
Fatigue Malignant Neoplasms | Level of fatigue
Item
must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine
boolean
C0015672 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C2586108 (UMLS CUI [2])
Able to read English Language
Item
be able to read english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Able to swallow oral medication
Item
able to swallow medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Informed Consent
Item
give written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Omega-3 Fatty Acids | Pharmaceutical Preparations Lovaza
Item
have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as lovaza®)
boolean
C0015689 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0912903 (UMLS CUI [2,2])
Anticoagulants | Aspirin
Item
be taking anticoagulant medication (does not include aspirin)
boolean
C0003280 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
Hypersensitivity Fishes | Hypersensitivity Shellfish
Item
have sensitivity or allergy to fish and/or shellfish
boolean
C0020517 (UMLS CUI [1,1])
C0016163 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1304606 (UMLS CUI [2,2])
Hypersensitivity Soy | Hypersensitivity Soybeans
Item
have sensitivity or allergy to soy and/or soybeans
boolean
C0020517 (UMLS CUI [1,1])
C2756587 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0037733 (UMLS CUI [2,2])
Chronic Fatigue Syndrome | Diagnosis Causing Fatigue Severe
Item
have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
boolean
C0015674 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0015672 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
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