ID

35089

Description

Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02403037

Link

https://clinicaltrials.gov/show/NCT02403037

Keywords

Versions (1)
  1. 2/15/19 2/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02403037

English

Eligibility Breast Neoplasms NCT02403037

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult female patients aged less than 50 years old;
Description

Adult | Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
a diagnosis of breast cancer stage i-iii;
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
chemotherapy- naive;
Description

Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
auricular therapy-naive;
Description

Therapeutic procedure Auricular Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1549094
UMLS CUI [1,3]
C0332197
be able to communicate in chinese mandarin;
Description

Able to communicate Mandarin language

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0682398
had at least completed a primary school education;
Description

Primary School Education Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0033145
UMLS CUI [1,2]
C0013621
UMLS CUI [1,3]
C0205197
agree to participate in the study and be willing to give written informed consent;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
scheduled to receive the first cycle of anthracycline-based chemotherapy with moderately high emetogenic potentials;
Description

Chemotherapy cycle First Scheduled | Anthracyclines | Potential Moderately High Emetogenic

Data type

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C0282564
UMLS CUI [3,1]
C3245505
UMLS CUI [3,2]
C0205081
UMLS CUI [3,3]
C0205250
UMLS CUI [3,4]
C0013973
be provided with standard antiemetic medications during chemotherapy.
Description

Standard Antiemetics During Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C0003297
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0392920
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
extremely weak, disabled or immunocompromised patients;
Description

Patients Extremely Weak | Disabled Persons | Immunocompromised Patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205403
UMLS CUI [1,3]
C1762617
UMLS CUI [2]
C0018576
UMLS CUI [3]
C0085393
not cooperate with the study intervention and any other procedures;
Description

Protocol Compliance Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0332268
have concurrent radiotherapy or other kinds of antineoplastic therapy;
Description

Therapeutic radiology procedure | Antineoplastic Drug/Agent Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C2346834
currently participate in studies on anti-emetic drugs or other kinds of non-pharmacological interventions to control cinv, or other studies which may have some interactions with the study;
Description

Study Subject Participation Status | Antiemetics | Intervention Control Chemotherapy-induced nausea and vomiting | Interaction Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0003297
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C2587213
UMLS CUI [3,3]
C0401160
UMLS CUI [4,1]
C1704675
UMLS CUI [4,2]
C0008976
have other health problems which may affect the symptoms of nausea and vomiting during chemotherapy including a series of gastrointestinal diseases, liver disease, migraine, tinnitus and ménière's disease, etc.;
Description

Medical Problem Affecting Nausea and vomiting symptoms | Gastrointestinal Disease | Liver disease | Migraine Disorders | Tinnitus | Meniere Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0027498
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0149931
UMLS CUI [5]
C0040264
UMLS CUI [6]
C0025281
have a history of chronic alcohol use which could contribute to minimal level of nausea or vomiting;
Description

Alcoholic Intoxication, Chronic | Contribution Level of nausea Minimal | Contribution Vomiting Level Minimal

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C1880177
UMLS CUI [2,2]
C3839628
UMLS CUI [2,3]
C0547040
UMLS CUI [3,1]
C1880177
UMLS CUI [3,2]
C0042963
UMLS CUI [3,3]
C0441889
UMLS CUI [3,4]
C0547040
ear skin problems which are not appropriate for auricular acupressure including infections, scars, rashes, frostbite, moles, ear abrasions or abscess, etc.
Description

Ear skin Problem | Patients Inappropriate Acupressure Auricular | Communicable Disease | Scar Tissue | Exanthema | Frostbite | Nevus | Ear abrasion | Abscess of the ear

Data type

boolean

Alias
UMLS CUI [1,1]
C0222110
UMLS CUI [1,2]
C0033213
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0282614
UMLS CUI [2,4]
C1549094
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0241158
UMLS CUI [5]
C0015230
UMLS CUI [6]
C0016736
UMLS CUI [7]
C0027960
UMLS CUI [8]
C0948401
UMLS CUI [9]
C1408787
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Similar models

Eligibility Breast Neoplasms NCT02403037

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age
Item
adult female patients aged less than 50 years old;
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Breast Carcinoma TNM Breast tumor staging
Item
a diagnosis of breast cancer stage i-iii;
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Chemotherapy Absent
Item
chemotherapy- naive;
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Therapeutic procedure Auricular Absent
Item
auricular therapy-naive;
boolean
C0087111 (UMLS CUI [1,1])
C1549094 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Able to communicate Mandarin language
Item
be able to communicate in chinese mandarin;
boolean
C2364293 (UMLS CUI [1,1])
C0682398 (UMLS CUI [1,2])
Primary School Education Completed
Item
had at least completed a primary school education;
boolean
C0033145 (UMLS CUI [1,1])
C0013621 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Informed Consent
Item
agree to participate in the study and be willing to give written informed consent;
boolean
C0021430 (UMLS CUI [1])
Chemotherapy cycle First Scheduled | Anthracyclines | Potential Moderately High Emetogenic
Item
scheduled to receive the first cycle of anthracycline-based chemotherapy with moderately high emetogenic potentials;
boolean
C1302181 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0282564 (UMLS CUI [2])
C3245505 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0205250 (UMLS CUI [3,3])
C0013973 (UMLS CUI [3,4])
Standard Antiemetics During Chemotherapy
Item
be provided with standard antiemetic medications during chemotherapy.
boolean
C1442989 (UMLS CUI [1,1])
C0003297 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Patients Extremely Weak | Disabled Persons | Immunocompromised Patients
Item
extremely weak, disabled or immunocompromised patients;
boolean
C0030705 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
C1762617 (UMLS CUI [1,3])
C0018576 (UMLS CUI [2])
C0085393 (UMLS CUI [3])
Protocol Compliance Lacking
Item
not cooperate with the study intervention and any other procedures;
boolean
C0525058 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Therapeutic radiology procedure | Antineoplastic Drug/Agent Therapy
Item
have concurrent radiotherapy or other kinds of antineoplastic therapy;
boolean
C1522449 (UMLS CUI [1])
C2346834 (UMLS CUI [2])
Study Subject Participation Status | Antiemetics | Intervention Control Chemotherapy-induced nausea and vomiting | Interaction Clinical Trial
Item
currently participate in studies on anti-emetic drugs or other kinds of non-pharmacological interventions to control cinv, or other studies which may have some interactions with the study;
boolean
C2348568 (UMLS CUI [1])
C0003297 (UMLS CUI [2])
C0184661 (UMLS CUI [3,1])
C2587213 (UMLS CUI [3,2])
C0401160 (UMLS CUI [3,3])
C1704675 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
Medical Problem Affecting Nausea and vomiting symptoms | Gastrointestinal Disease | Liver disease | Migraine Disorders | Tinnitus | Meniere Disease
Item
have other health problems which may affect the symptoms of nausea and vomiting during chemotherapy including a series of gastrointestinal diseases, liver disease, migraine, tinnitus and ménière's disease, etc.;
boolean
C1254481 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0027498 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0149931 (UMLS CUI [4])
C0040264 (UMLS CUI [5])
C0025281 (UMLS CUI [6])
Alcoholic Intoxication, Chronic | Contribution Level of nausea Minimal | Contribution Vomiting Level Minimal
Item
have a history of chronic alcohol use which could contribute to minimal level of nausea or vomiting;
boolean
C0001973 (UMLS CUI [1])
C1880177 (UMLS CUI [2,1])
C3839628 (UMLS CUI [2,2])
C0547040 (UMLS CUI [2,3])
C1880177 (UMLS CUI [3,1])
C0042963 (UMLS CUI [3,2])
C0441889 (UMLS CUI [3,3])
C0547040 (UMLS CUI [3,4])
Ear skin Problem | Patients Inappropriate Acupressure Auricular | Communicable Disease | Scar Tissue | Exanthema | Frostbite | Nevus | Ear abrasion | Abscess of the ear
Item
ear skin problems which are not appropriate for auricular acupressure including infections, scars, rashes, frostbite, moles, ear abrasions or abscess, etc.
boolean
C0222110 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0282614 (UMLS CUI [2,3])
C1549094 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3])
C0241158 (UMLS CUI [4])
C0015230 (UMLS CUI [5])
C0016736 (UMLS CUI [6])
C0027960 (UMLS CUI [7])
C0948401 (UMLS CUI [8])
C1408787 (UMLS CUI [9])
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