ID

37998

Descrição

Cocinar Para su Salud! (Cook for Your Life!); ODM derived from: https://clinicaltrials.gov/show/NCT01414062

Link

https://clinicaltrials.gov/show/NCT01414062

Palavras-chave

Versões (1)
  1. 06/09/2019 06/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01414062

Inglês

Eligibility Breast Cancer NCT01414062

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female.
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
age 21 years or greater. both pre- and postmenopausal women will be included in this study. postmenopausal status will be defined as the absence of menses for > 12 months, serum fsh > 20 miu/ml, or history of bilateral oophrectomy.
Descrição

Age | Premenopausal state | Postmenopausal state | Serum follicle stimulating hormone measurement | Bilateral oophorectomy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232969
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0455276
UMLS CUI [5]
C0278321
hispanic descent and fluent in spanish.
Descrição

Hispanics | Able to speak fluently Spanish Language

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086409
UMLS CUI [2,1]
C0564241
UMLS CUI [2,2]
C0037750
history of histologically-confirmed stage 0, i, ii, or iii (see appendix i for tnm staging system) invasive breast carcinoma without evidence of disease recurrent or metastatic disease at trial entry.
Descrição

Invasive carcinoma of breast TNM Breast tumor staging | Recurrent disease Absent | Neoplasm Metastasis Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
minimum of 3 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery. current use of hormonal therapy is permitted.
Descrição

Prior Chemotherapy | Prior biologic therapy | trastuzumab | Prior radiation therapy | Operation on breast Previous | Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0278947
UMLS CUI [3]
C0728747
UMLS CUI [4]
C0279134
UMLS CUI [5,1]
C3714726
UMLS CUI [5,2]
C0205156
UMLS CUI [6]
C0279025
no uncontrolled diabetes mellitus, defined as hgb a1c >7.
Descrição

Diabetic - poor control | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0474680
no uncontrolled comorbidities (i.e., hypertension).
Descrição

Comorbidity Uncontrolled Absent | Uncontrolled hypertension Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332197
currently a non-smoker (rationale: women who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for these women to stop smoking than it is to change their dietary patterns).
Descrição

Non-smoker

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0337672
consumes <5 servings of fruits and vegetables per day, as assessed by the block fruit and vegetable screener.
Descrição

Consumption of Fruits Serving per day | Consumption of Vegetables Serving per day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0016767
UMLS CUI [1,3]
C1519269
UMLS CUI [1,4]
C0439505
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0042440
UMLS CUI [2,3]
C1519269
UMLS CUI [2,4]
C0439505
in the pre-contemplation, contemplation, or preparation stage of increasing daily fruit and vegetable intake.
Descrição

Intake Increasing Fruits per day | Intake Increasing Vegetables per day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512806
UMLS CUI [1,2]
C0442808
UMLS CUI [1,3]
C0016767
UMLS CUI [1,4]
C0439505
UMLS CUI [2,1]
C1512806
UMLS CUI [2,2]
C0442808
UMLS CUI [2,3]
C0042440
UMLS CUI [2,4]
C0439505
access to functional home phone or cell phone.
Descrição

Access HOME PHONE | Access Cellular Phone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0444454
UMLS CUI [1,2]
C0745029
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C1136359
willing and able to participate in all study related activities, including study clinic visits, phone interviews, and nutrition counseling sessions.
Descrição

Protocol Compliance | Clinic Visits | Interviews, Telephone | Nutrition counseling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0008952
UMLS CUI [3]
C0021823
UMLS CUI [4]
C3714365
ability to understand and willingness to sign a written informed consent document
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of recurrent or metastatic breast cancer.
Descrição

Breast cancer recurrent | Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2]
C0346993
uncontrolled diabetes (type 1 or 2), defined as hgb a1c >7.
Descrição

DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743113
UMLS CUI [2]
C0743118
UMLS CUI [3]
C0474680
uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; active malignancy, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, stages ia or ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, stage ia grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements.
Descrição

Comorbidity Uncontrolled | Comorbidity Significant | Communicable Disease Requirement Antibiotics Intravenous | Communicable Disease Serious | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Gastrointestinal Hemorrhage | Liver disease | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in Situ | Exception Cervical Squamous Cell Carcinoma Invasive TNM clinical staging | Operative Surgical Procedures | Therapeutic radiology procedure | Exception Endometrial adenocarcinoma TNM clinical staging | Chemotherapy | Therapeutic radiology procedure | Illness Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0003232
UMLS CUI [3,4]
C1522726
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205404
UMLS CUI [5]
C0742758
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0003811
UMLS CUI [8]
C0017181
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0006826
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0553723
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0007117
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0007099
UMLS CUI [14,1]
C1705847
UMLS CUI [14,2]
C0279671
UMLS CUI [14,3]
C0205281
UMLS CUI [14,4]
C3258246
UMLS CUI [15]
C0543467
UMLS CUI [16]
C1522449
UMLS CUI [17,1]
C1705847
UMLS CUI [17,2]
C1153706
UMLS CUI [17,3]
C3258246
UMLS CUI [18]
C0392920
UMLS CUI [19]
C1522449
UMLS CUI [20,1]
C0221423
UMLS CUI [20,2]
C0439801
UMLS CUI [20,3]
C0525058
UMLS CUI [21,1]
C0748872
UMLS CUI [21,2]
C0439801
UMLS CUI [21,3]
C0525058
previously participated in cook for your life! classes.
Descrição

Participation Cooking Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0335326
UMLS CUI [1,3]
C0456387
currently active in a dietary change program.
Descrição

Participation Change in diet Program

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C3671772
UMLS CUI [1,3]
C3484370
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Similar models

Eligibility Breast Cancer NCT01414062

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female.
boolean
C0079399 (UMLS CUI [1])
Age | Premenopausal state | Postmenopausal state | Serum follicle stimulating hormone measurement | Bilateral oophorectomy
Item
age 21 years or greater. both pre- and postmenopausal women will be included in this study. postmenopausal status will be defined as the absence of menses for > 12 months, serum fsh > 20 miu/ml, or history of bilateral oophrectomy.
boolean
C0001779 (UMLS CUI [1])
C0232969 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0455276 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
Hispanics | Able to speak fluently Spanish Language
Item
hispanic descent and fluent in spanish.
boolean
C0086409 (UMLS CUI [1])
C0564241 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Invasive carcinoma of breast TNM Breast tumor staging | Recurrent disease Absent | Neoplasm Metastasis Absent
Item
history of histologically-confirmed stage 0, i, ii, or iii (see appendix i for tnm staging system) invasive breast carcinoma without evidence of disease recurrent or metastatic disease at trial entry.
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Prior Chemotherapy | Prior biologic therapy | trastuzumab | Prior radiation therapy | Operation on breast Previous | Hormone Therapy
Item
minimum of 3 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery. current use of hormonal therapy is permitted.
boolean
C1514457 (UMLS CUI [1])
C0278947 (UMLS CUI [2])
C0728747 (UMLS CUI [3])
C0279134 (UMLS CUI [4])
C3714726 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C0279025 (UMLS CUI [6])
Diabetic - poor control | Hemoglobin A1c measurement
Item
no uncontrolled diabetes mellitus, defined as hgb a1c >7.
boolean
C0421258 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Comorbidity Uncontrolled Absent | Uncontrolled hypertension Absent
Item
no uncontrolled comorbidities (i.e., hypertension).
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Non-smoker
Item
currently a non-smoker (rationale: women who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for these women to stop smoking than it is to change their dietary patterns).
boolean
C0337672 (UMLS CUI [1])
Consumption of Fruits Serving per day | Consumption of Vegetables Serving per day
Item
consumes <5 servings of fruits and vegetables per day, as assessed by the block fruit and vegetable screener.
boolean
C0009830 (UMLS CUI [1,1])
C0016767 (UMLS CUI [1,2])
C1519269 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C0009830 (UMLS CUI [2,1])
C0042440 (UMLS CUI [2,2])
C1519269 (UMLS CUI [2,3])
C0439505 (UMLS CUI [2,4])
Intake Increasing Fruits per day | Intake Increasing Vegetables per day
Item
in the pre-contemplation, contemplation, or preparation stage of increasing daily fruit and vegetable intake.
boolean
C1512806 (UMLS CUI [1,1])
C0442808 (UMLS CUI [1,2])
C0016767 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C1512806 (UMLS CUI [2,1])
C0442808 (UMLS CUI [2,2])
C0042440 (UMLS CUI [2,3])
C0439505 (UMLS CUI [2,4])
Access HOME PHONE | Access Cellular Phone
Item
access to functional home phone or cell phone.
boolean
C0444454 (UMLS CUI [1,1])
C0745029 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C1136359 (UMLS CUI [2,2])
Protocol Compliance | Clinic Visits | Interviews, Telephone | Nutrition counseling
Item
willing and able to participate in all study related activities, including study clinic visits, phone interviews, and nutrition counseling sessions.
boolean
C0525058 (UMLS CUI [1])
C0008952 (UMLS CUI [2])
C0021823 (UMLS CUI [3])
C3714365 (UMLS CUI [4])
Informed Consent
Item
ability to understand and willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast cancer recurrent | Secondary malignant neoplasm of female breast
Item
evidence of recurrent or metastatic breast cancer.
boolean
C0278493 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
DIABETES MELLITUS INSULIN DEPENDENT UNCONTROLLED | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED | Hemoglobin A1c measurement
Item
uncontrolled diabetes (type 1 or 2), defined as hgb a1c >7.
boolean
C0743113 (UMLS CUI [1])
C0743118 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Comorbidity Uncontrolled | Comorbidity Significant | Communicable Disease Requirement Antibiotics Intravenous | Communicable Disease Serious | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Gastrointestinal Hemorrhage | Liver disease | Malignant Neoplasms | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in Situ | Exception Cervical Squamous Cell Carcinoma Invasive TNM clinical staging | Operative Surgical Procedures | Therapeutic radiology procedure | Exception Endometrial adenocarcinoma TNM clinical staging | Chemotherapy | Therapeutic radiology procedure | Illness Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; active malignancy, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, stages ia or ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, stage ia grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003232 (UMLS CUI [3,3])
C1522726 (UMLS CUI [3,4])
C0009450 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0742758 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0017181 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0553723 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C0007117 (UMLS CUI [12,2])
C1705847 (UMLS CUI [13,1])
C0007099 (UMLS CUI [13,2])
C1705847 (UMLS CUI [14,1])
C0279671 (UMLS CUI [14,2])
C0205281 (UMLS CUI [14,3])
C3258246 (UMLS CUI [14,4])
C0543467 (UMLS CUI [15])
C1522449 (UMLS CUI [16])
C1705847 (UMLS CUI [17,1])
C1153706 (UMLS CUI [17,2])
C3258246 (UMLS CUI [17,3])
C0392920 (UMLS CUI [18])
C1522449 (UMLS CUI [19])
C0221423 (UMLS CUI [20,1])
C0439801 (UMLS CUI [20,2])
C0525058 (UMLS CUI [20,3])
C0748872 (UMLS CUI [21,1])
C0439801 (UMLS CUI [21,2])
C0525058 (UMLS CUI [21,3])
Participation Cooking Class
Item
previously participated in cook for your life! classes.
boolean
C0679823 (UMLS CUI [1,1])
C0335326 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Participation Change in diet Program
Item
currently active in a dietary change program.
boolean
C0679823 (UMLS CUI [1,1])
C3671772 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
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