ID

34980

Description

Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02081612

Lien

https://clinicaltrials.gov/show/NCT02081612

Mots-clés

Versions (1)
  1. 06/02/2019 06/02/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

6 février 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02081612

Anglais

Eligibility Breast Cancer NCT02081612

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
woman with a diagnosis of breast cancer, stage i, ii, or iii
Description

Gender | Breast Carcinoma TNM Breast tumor staging

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0474926
age ≥ 18
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status ≤ 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
Description

Treatment completed Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0678222
bmi ≥ 30
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
adequate bone marrow and organ function as determined by the consenting/enrolling investigator
Description

Bone Marrow function | Organ function

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
signed informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
any receptor status
Description

Receptor status Any

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449443
UMLS CUI [1,2]
C1552551
participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
current chemotherapy or radiation therapy. participants in study may still be receiving hormone or herceptin treatment.
Description

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy allowed | Herceptin allowed

Type de données

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0338204
UMLS CUI [4,2]
C0683607
diagnosis of metastatic breast cancer
Description

Secondary malignant neoplasm of female breast

Type de données

boolean

Alias
UMLS CUI [1]
C0346993
participation in other diet-based weight loss programs (ie. patient should not be currently enrolled in weight watchers, jenny craig, nutrisystem, etc.)
Description

Participation Weight Reduction Programs Dietary

Type de données

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3179079
UMLS CUI [1,3]
C0012155
current use of commercial or natural/herbal weight loss supplements
Description

Weight-Loss Agents | HERBAL WEIGHT LOSS AID

Type de données

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C1572271
major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
Description

Major surgery | Effects of Major surgery Patient recovered

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1704420
UMLS CUI [2,2]
C0679637
UMLS CUI [2,3]
C1115804
other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
Description

Cancer Other | Exception Cervix carcinoma Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0302592
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
personal history of an eating disorder
Description

Eating Disorder

Type de données

boolean

Alias
UMLS CUI [1]
C0013473
other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled hiv, hepatitis b or c), or any psychiatric disorder that prohibits obtaining informed consent
Description

Disease Serious Uncontrolled | Systemic disease Except Malignant Neoplasms | Communicable Disease Uncontrolled | HIV Infection Uncontrolled | Hepatitis B Uncontrolled | Hepatitis C Uncontrolled | Mental disorder Preventing Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0019693
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0019163
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C0019196
UMLS CUI [6,2]
C0205318
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C0021430
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Similar models

Eligibility Breast Cancer NCT02081612

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma TNM Breast tumor staging
Item
woman with a diagnosis of breast cancer, stage i, ii, or iii
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
Age
Item
age ≥ 18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Treatment completed Breast Carcinoma
Item
received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
boolean
C0580352 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Body mass index
Item
bmi ≥ 30
boolean
C1305855 (UMLS CUI [1])
Bone Marrow function | Organ function
Item
adequate bone marrow and organ function as determined by the consenting/enrolling investigator
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Receptor status Any
Item
any receptor status
boolean
C0449443 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Protocol Compliance
Item
participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Hormone Therapy allowed | Herceptin allowed
Item
current chemotherapy or radiation therapy. participants in study may still be receiving hormone or herceptin treatment.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0338204 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Secondary malignant neoplasm of female breast
Item
diagnosis of metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Participation Weight Reduction Programs Dietary
Item
participation in other diet-based weight loss programs (ie. patient should not be currently enrolled in weight watchers, jenny craig, nutrisystem, etc.)
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0012155 (UMLS CUI [1,3])
Weight-Loss Agents | HERBAL WEIGHT LOSS AID
Item
current use of commercial or natural/herbal weight loss supplements
boolean
C0376606 (UMLS CUI [1])
C1572271 (UMLS CUI [2])
Major surgery | Effects of Major surgery Patient recovered
Item
major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
boolean
C0679637 (UMLS CUI [1])
C1704420 (UMLS CUI [2,1])
C0679637 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
Cancer Other | Exception Cervix carcinoma Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0302592 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Eating Disorder
Item
personal history of an eating disorder
boolean
C0013473 (UMLS CUI [1])
Disease Serious Uncontrolled | Systemic disease Except Malignant Neoplasms | Communicable Disease Uncontrolled | HIV Infection Uncontrolled | Hepatitis B Uncontrolled | Hepatitis C Uncontrolled | Mental disorder Preventing Informed Consent
Item
other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled hiv, hepatitis b or c), or any psychiatric disorder that prohibits obtaining informed consent
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0019163 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0019196 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
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