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ID

16475

Description

Exercise in Women at Risk for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00092950

Lien

https://clinicaltrials.gov/show/NCT00092950

Mots-clés

  1. 17/07/2016 17/07/2016 -
  2. 18/07/2016 18/07/2016 -
Téléchargé le

18 juillet 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Breast Neoplasms NCT00092950

    Eligibility Breast Neoplasms NCT00092950

    Criteria
    Description

    Criteria

    this study will enroll 40 breast cancer survivors and 40 women at high risk for breast cancer. all participants must fulfill the following criteria:
    Description

    Breast Carcinoma Survivors | Gender At high risk for breast cancer

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    UMLS CUI [1,2]
    C0206194 (Survivors)
    UMLS CUI [2,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2,2]
    C4047809 (At high risk for breast cancer)
    SNOMED
    448731000124102
    age 18 to 75.
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    sedentary at baseline, as defined by a weekly leisure-time activity score of 15 or less on the godin leisure-time exercise questionnaire. this cutoff is equivalent to engaging in moderate activity less than 3 times a week.
    Description

    Sedentary | Leisure Activities Weekly Score | Exercise Leisure Questionnaires | Moderate activity Weekly Quantity

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1532253 (Sedentary lifestyle)
    SNOMED
    415510005
    UMLS CUI [2,1]
    C0023292 (Leisure Activities)
    UMLS CUI [2,2]
    C0332174 (Weekly)
    SNOMED
    259038000
    LOINC
    LA18891-4
    UMLS CUI [2,3]
    C0449820 (Score)
    SNOMED
    246262008
    LOINC
    MTHU024701
    UMLS CUI [3,1]
    C0015259 (Exercise)
    SNOMED
    183301007
    LOINC
    LP61581-2
    UMLS CUI [3,2]
    C0086542 (Leisure)
    LOINC
    LA9374-5
    UMLS CUI [3,3]
    C0034394 (Questionnaires)
    UMLS CUI [4,1]
    C3833417 (Moderate activity)
    LOINC
    LA9642-5
    UMLS CUI [4,2]
    C0332174 (Weekly)
    SNOMED
    259038000
    LOINC
    LA18891-4
    UMLS CUI [4,3]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    ability to complete all study questionnaires, or a willing friend or family member who will assist in questionnaire completion.
    Description

    Clinical Trial Subject Questionnaire Completion Ability | Clinical Trial Subject Questionnaire Completion Assisted

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3890411 (Clinical Trial Subject Questionnaire)
    UMLS CUI [1,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [1,3]
    C0085732 (Ability)
    UMLS CUI [2,1]
    C3890411 (Clinical Trial Subject Questionnaire)
    UMLS CUI [2,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [2,3]
    C1269765 (Assisted (qualifier value))
    SNOMED
    371152001
    ecog performance status 0-1.
    Description

    ECOG performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    ability to successfully perform the level of physical activity prescribed by the protocol, as assessed by the physical activity readiness questionnaire (par-q).
    Description

    Physical activity Level Perform Ability

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0026606 (Physical activity)
    SNOMED
    48761009
    LOINC
    LP34367-0
    UMLS CUI [1,2]
    C0441889 (Levels (qualifier value))
    SNOMED
    258395000
    UMLS CUI [1,3]
    C0884358 (Performed)
    SNOMED
    398166005
    LOINC
    LA19974-7
    UMLS CUI [1,4]
    C0085732 (Ability)
    any participant who answers yes to any of the questions in this screening tool will undergo medical evaluation at the clinical center, as appropriate, prior to enrolling on the study.
    Description

    answered questions Screening | Clinical Evaluation

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0508431 (answer questions)
    UMLS CUI [1,2]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [2]
    C1261322 (Evaluation procedure)
    SNOMED
    129265001
    LOINC
    LA15395-9
    cardiac risk will be assessed after a complete history and physical exam, and will be determined by the examining physician. only patients who are felt to be increased cardiac risk will have an ekg performed. this will include patients who answer yes to any of the questions on the par-q that assess cardiac risk (#1,2,3,4,6). patients with worrisome ekg findings or findings in the history or physical exam that warrant further work-up in the opinion of the health care provider will be referred to the cardiology consult service, or if non-urgent, will be referred back to their source of regular medical care for clearance prior to enrolling on the study.
    Description

    Cardiac heart disease risk | Physical Examination | Electrocardiography Due to Cardiac heart disease risk Increased | Medical care Regular

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2734561 (Cardiac heart disease risk)
    LOINC
    LP96138-0
    UMLS CUI [2]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [3,1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    UMLS CUI [3,2]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [3,3]
    C2734561 (Cardiac heart disease risk)
    LOINC
    LP96138-0
    UMLS CUI [3,4]
    C0205217 (Increased)
    SNOMED
    35105006
    LOINC
    LA24377-6
    UMLS CUI [4,1]
    C0496675 (Medical care)
    SNOMED
    781087000
    UMLS CUI [4,2]
    C0205272 (Regular)
    SNOMED
    17854005
    LOINC
    LA15487-4
    if history of cancer (other than invasive breast cancer, squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment and no history of cancer directed treatment in the 2 years preceding enrollment.
    Description

    Malignant Neoplasms | Invasive carcinoma of breast | Squamous cell carcinoma of skin | Basal cell carcinoma | Disease Evidence of | cancer treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2]
    C0853879 (Invasive carcinoma of breast)
    SNOMED
    713609000
    UMLS CUI [3]
    C0553723 (Squamous cell carcinoma of skin)
    SNOMED
    254651007
    UMLS CUI [4]
    C0007117 (Basal cell carcinoma)
    SNOMED
    1338007
    UMLS CUI [5,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [5,2]
    C0332120 (Evidence of (contextual qualifier))
    SNOMED
    18669006
    UMLS CUI [6]
    C0920425 (cancer treatment)
    breast cancer survivors:
    Description

    Breast Carcinoma Survivors

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    UMLS CUI [1,2]
    C0206194 (Survivors)
    eligible breast cancer survivors will be women with a documented history of stage i, ii or iii invasive breast cancer who are at least two months from the completion of their primary therapy, including surgery, radiation and chemotherapy. current use of hormonal therapy such as tamoxifen or aromatase inhibitors, will be permitted, however subjects must have completed 2 months of hormonal therapy prior to beginning the study in order to achieve steady state.
    Description

    Breast Carcinoma Survivors | Gender | Invasive carcinoma of breast | TNM clinical staging | First line treatment | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy Regimen | Hormone Therapy | Tamoxifen | Aromatase Inhibitors

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0678222 (Breast Carcinoma)
    SNOMED
    254838004
    UMLS CUI [1,2]
    C0206194 (Survivors)
    UMLS CUI [2]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [3]
    C0853879 (Invasive carcinoma of breast)
    SNOMED
    713609000
    UMLS CUI [4]
    C3258246 (TNM clinical staging)
    LOINC
    LP130437-9
    UMLS CUI [5]
    C1708063 (First line treatment)
    SNOMED
    708255002
    UMLS CUI [6]
    C0543467 (Operative Surgical Procedures)
    SNOMED
    257556004
    LOINC
    LP7802-4
    UMLS CUI [7]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [8]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [9]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    UMLS CUI [10]
    C0039286 (tamoxifen)
    SNOMED
    75959001
    UMLS CUI [11]
    C0593802 (Aromatase Inhibitors)
    SNOMED
    413575009
    women at high risk for breast cancer:
    Description

    Gender At high risk for breast cancer

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [1,2]
    C4047809 (At high risk for breast cancer)
    SNOMED
    448731000124102
    women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:
    Description

    Gender At high risk for breast cancer | criteria Fulfill

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [1,2]
    C4047809 (At high risk for breast cancer)
    SNOMED
    448731000124102
    UMLS CUI [2,1]
    C0243161 (criteria)
    UMLS CUI [2,2]
    C1550543 (Fulfill)
    a gail model risk of greater than or equal to1.7 percent over 5 years from study entry or a claus model lifetime risk of greater than 20 percent.
    Description

    Gail Risk Model | Claus Model Lifetime Risk

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1511297 (Breast Cancer Risk Assessment Tool)
    SNOMED
    717130009
    UMLS CUI [2,1]
    C1707405 (Claus Model)
    SNOMED
    717129004
    UMLS CUI [2,2]
    C1517878 (Lifetime Risk)
    lobular neoplasia.
    Description

    Lobular Neoplasia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0861352 (Lobular Neoplasia)
    atypical ductal hyperplasia.
    Description

    Atypical ductal hyperplasia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0442834 (Atypical ductal hyperplasia (qualifier value))
    SNOMED
    264505003
    ductal carcinoma in situ (dcis) that has been previously treated. patients must be at least 2 months from completion of primary therapy, and if treated with hormonal therapy, they must have completed at least two months of hormonal therapy.
    Description

    Prior Therapy Noninfiltrating Intraductal Carcinoma | First line treatment Complete | Hormone Therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C0007124 (Noninfiltrating Intraductal Carcinoma)
    SNOMED
    86616005
    LOINC
    LP57573-5
    UMLS CUI [2,1]
    C1708063 (First line treatment)
    SNOMED
    708255002
    UMLS CUI [2,2]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    UMLS CUI [3]
    C0279025 (Hormone Therapy)
    SNOMED
    169413002
    deleterious mutations in brca-1 or 2 or a priori risk assessment of 20 percent chance or greater of carrying a brca1/2 gene mutation. the brcapro model (109) will be used to assess this risk.
    Description

    BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation | Risk Assessment BRCAPRO | BRCA1 gene mutation | BRCA2 gene mutation

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0376571 (BRCA1 gene)
    LOINC
    LP19666-4
    UMLS CUI [1,2]
    C2985436 (Deleterious Mutation)
    UMLS CUI [2,1]
    C0598034 (BRCA2 gene)
    LOINC
    LP31855-7
    UMLS CUI [2,2]
    C2985436 (Deleterious Mutation)
    UMLS CUI [3,1]
    C0086930 (Risk Assessment)
    SNOMED
    225338004
    LOINC
    LP149830-4
    UMLS CUI [3,2]
    C1879774 (BRCAPRO)
    LOINC
    LA20167-5
    UMLS CUI [4]
    C1511022 (BRCA1 gene mutation)
    UMLS CUI [5]
    C1511024 (BRCA2 gene mutation)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    currently pregnant or planning to become pregnant during the study period. pregnancy will be assessed in women of childbearing potential prior to enrolling in stage ii of the study. postmenopausal women and women who have had a previous hysterectomy, oophorectomy or tubal ligation will not be required to undergo a pregnancy test.
    Description

    Pregnancy | Pregnancy, Planned | Childbearing Potential | Postmenopausal state | Hysterectomy | Ovariectomy | Tubal Ligation | Pregnancy Test

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0032992 (Pregnancy, Planned)
    SNOMED
    169565003
    UMLS CUI [3]
    C3831118 (Childbearing Potential)
    UMLS CUI [4]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    UMLS CUI [5]
    C0020699 (Hysterectomy)
    SNOMED
    236886002
    LOINC
    LP100604-0
    UMLS CUI [6]
    C0029936 (Ovariectomy)
    SNOMED
    83152002
    UMLS CUI [7]
    C0520483 (Tubal Ligation)
    SNOMED
    77543007
    UMLS CUI [8]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent myocardial infarction or stroke, or psychiatric illness/social situations that would limit compliance with study requirements.
    Description

    Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Recent myocardial infarction | Cerebrovascular accident Recent | Mental disorder Compliance behavior Limited | social situation Compliance behavior Limited

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488 (Comorbidity)
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [2]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [3]
    C0742758 (Symptomatic congestive heart failure)
    SNOMED
    698594003
    UMLS CUI [4]
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    UMLS CUI [5]
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    UMLS CUI [6]
    C1998297 (Recent myocardial infarction)
    SNOMED
    428752002
    UMLS CUI [7,1]
    C0038454 (Cerebrovascular accident)
    SNOMED
    230690007
    LOINC
    MTHU020801
    UMLS CUI [7,2]
    C0332185 (Recent)
    SNOMED
    6493001
    UMLS CUI [8,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [8,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [8,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [9,1]
    C0748872 (social situation)
    UMLS CUI [9,2]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [9,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    physical conditions that preclude the amount of daily walking prescribed by the protocol (e.g., severe arthritis, use of a walker or cane, wheelchair-bound, etc.).
    Description

    Physical Condition Exclusion Walking Daily Quantity | Requirement Study Protocol | Arthritis Severe | Walker user | Cane user | Wheelchair bound

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3714565 (Individual Physical Condition)
    UMLS CUI [1,2]
    C2828389 (Exclusion)
    UMLS CUI [1,3]
    C0080331 (Walking (activity))
    SNOMED
    870595007
    LOINC
    LA11834-1
    UMLS CUI [1,4]
    C0332173 (Daily)
    SNOMED
    69620002
    LOINC
    LA14799-3
    UMLS CUI [1,5]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [2,1]
    C1514873 (Requirement)
    UMLS CUI [2,2]
    C2348563 (Study Protocol)
    UMLS CUI [3,1]
    C0003864 (Arthritis)
    SNOMED
    3723001
    LOINC
    LP28762-0
    UMLS CUI [3,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [4]
    C0920121 (Walker user)
    UMLS CUI [5]
    C0920240 (Cane user)
    UMLS CUI [6]
    C0558195 (Wheelchair bound)
    SNOMED
    225612007
    medical or psychiatric disorder which would, in the opinion of the principal investigator, render the subject unable to provide informed consent.
    Description

    Disease Informed Consent Unable | Mental disorder Informed Consent Unable

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    UMLS CUI [2,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [2,2]
    C0021430 (Informed Consent)
    UMLS CUI [2,3]
    C1299582 (Unable)
    SNOMED
    371151008
    LOINC
    LA13868-7
    patients with metastatic or recurrent disease will be excluded because of difficulty interpreting results in the context of women with a disease burden and/or on chemotherapy.
    Description

    Metastatic Neoplasm | Recurrent disease | research results Interpretation Difficult | Gender | Chemotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2939420 (Metastatic Neoplasm)
    UMLS CUI [2]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    UMLS CUI [3,1]
    C0683954 (research results)
    UMLS CUI [3,2]
    C0459471 (Interpretation Process)
    SNOMED
    280452008
    LOINC
    LP21032-5
    UMLS CUI [3,3]
    C0332218 (Difficult (qualifier value))
    SNOMED
    52925006
    LOINC
    LA14626-8
    UMLS CUI [4]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [5]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004

    Similar models

    Eligibility Breast Neoplasms NCT00092950

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Breast Carcinoma Survivors | Gender At high risk for breast cancer
    Item
    this study will enroll 40 breast cancer survivors and 40 women at high risk for breast cancer. all participants must fulfill the following criteria:
    boolean
    C0678222 (UMLS CUI [1,1])
    C0206194 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C4047809 (UMLS CUI [2,2])
    Age
    Item
    age 18 to 75.
    boolean
    C0001779 (UMLS CUI [1])
    Sedentary | Leisure Activities Weekly Score | Exercise Leisure Questionnaires | Moderate activity Weekly Quantity
    Item
    sedentary at baseline, as defined by a weekly leisure-time activity score of 15 or less on the godin leisure-time exercise questionnaire. this cutoff is equivalent to engaging in moderate activity less than 3 times a week.
    boolean
    C1532253 (UMLS CUI [1])
    C0023292 (UMLS CUI [2,1])
    C0332174 (UMLS CUI [2,2])
    C0449820 (UMLS CUI [2,3])
    C0015259 (UMLS CUI [3,1])
    C0086542 (UMLS CUI [3,2])
    C0034394 (UMLS CUI [3,3])
    C3833417 (UMLS CUI [4,1])
    C0332174 (UMLS CUI [4,2])
    C1265611 (UMLS CUI [4,3])
    Clinical Trial Subject Questionnaire Completion Ability | Clinical Trial Subject Questionnaire Completion Assisted
    Item
    ability to complete all study questionnaires, or a willing friend or family member who will assist in questionnaire completion.
    boolean
    C3890411 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0085732 (UMLS CUI [1,3])
    C3890411 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C1269765 (UMLS CUI [2,3])
    ECOG performance status
    Item
    ecog performance status 0-1.
    boolean
    C1520224 (UMLS CUI [1])
    Physical activity Level Perform Ability
    Item
    ability to successfully perform the level of physical activity prescribed by the protocol, as assessed by the physical activity readiness questionnaire (par-q).
    boolean
    C0026606 (UMLS CUI [1,1])
    C0441889 (UMLS CUI [1,2])
    C0884358 (UMLS CUI [1,3])
    C0085732 (UMLS CUI [1,4])
    answered questions Screening | Clinical Evaluation
    Item
    any participant who answers yes to any of the questions in this screening tool will undergo medical evaluation at the clinical center, as appropriate, prior to enrolling on the study.
    boolean
    C0508431 (UMLS CUI [1,1])
    C0220908 (UMLS CUI [1,2])
    C1261322 (UMLS CUI [2])
    Cardiac heart disease risk | Physical Examination | Electrocardiography Due to Cardiac heart disease risk Increased | Medical care Regular
    Item
    cardiac risk will be assessed after a complete history and physical exam, and will be determined by the examining physician. only patients who are felt to be increased cardiac risk will have an ekg performed. this will include patients who answer yes to any of the questions on the par-q that assess cardiac risk (#1,2,3,4,6). patients with worrisome ekg findings or findings in the history or physical exam that warrant further work-up in the opinion of the health care provider will be referred to the cardiology consult service, or if non-urgent, will be referred back to their source of regular medical care for clearance prior to enrolling on the study.
    boolean
    C2734561 (UMLS CUI [1])
    C0031809 (UMLS CUI [2])
    C1623258 (UMLS CUI [3,1])
    C0678226 (UMLS CUI [3,2])
    C2734561 (UMLS CUI [3,3])
    C0205217 (UMLS CUI [3,4])
    C0496675 (UMLS CUI [4,1])
    C0205272 (UMLS CUI [4,2])
    Malignant Neoplasms | Invasive carcinoma of breast | Squamous cell carcinoma of skin | Basal cell carcinoma | Disease Evidence of | cancer treatment
    Item
    if history of cancer (other than invasive breast cancer, squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment and no history of cancer directed treatment in the 2 years preceding enrollment.
    boolean
    C0006826 (UMLS CUI [1])
    C0853879 (UMLS CUI [2])
    C0553723 (UMLS CUI [3])
    C0007117 (UMLS CUI [4])
    C0012634 (UMLS CUI [5,1])
    C0332120 (UMLS CUI [5,2])
    C0920425 (UMLS CUI [6])
    Breast Carcinoma Survivors
    Item
    breast cancer survivors:
    boolean
    C0678222 (UMLS CUI [1,1])
    C0206194 (UMLS CUI [1,2])
    Breast Carcinoma Survivors | Gender | Invasive carcinoma of breast | TNM clinical staging | First line treatment | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy Regimen | Hormone Therapy | Tamoxifen | Aromatase Inhibitors
    Item
    eligible breast cancer survivors will be women with a documented history of stage i, ii or iii invasive breast cancer who are at least two months from the completion of their primary therapy, including surgery, radiation and chemotherapy. current use of hormonal therapy such as tamoxifen or aromatase inhibitors, will be permitted, however subjects must have completed 2 months of hormonal therapy prior to beginning the study in order to achieve steady state.
    boolean
    C0678222 (UMLS CUI [1,1])
    C0206194 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2])
    C0853879 (UMLS CUI [3])
    C3258246 (UMLS CUI [4])
    C1708063 (UMLS CUI [5])
    C0543467 (UMLS CUI [6])
    C1522449 (UMLS CUI [7])
    C0392920 (UMLS CUI [8])
    C0279025 (UMLS CUI [9])
    C0039286 (UMLS CUI [10])
    C0593802 (UMLS CUI [11])
    Gender At high risk for breast cancer
    Item
    women at high risk for breast cancer:
    boolean
    C0079399 (UMLS CUI [1,1])
    C4047809 (UMLS CUI [1,2])
    Gender At high risk for breast cancer | criteria Fulfill
    Item
    women will be considered at high risk for developing breast cancer if they fulfill one of the following criteria:
    boolean
    C0079399 (UMLS CUI [1,1])
    C4047809 (UMLS CUI [1,2])
    C0243161 (UMLS CUI [2,1])
    C1550543 (UMLS CUI [2,2])
    Gail Risk Model | Claus Model Lifetime Risk
    Item
    a gail model risk of greater than or equal to1.7 percent over 5 years from study entry or a claus model lifetime risk of greater than 20 percent.
    boolean
    C1511297 (UMLS CUI [1])
    C1707405 (UMLS CUI [2,1])
    C1517878 (UMLS CUI [2,2])
    Lobular Neoplasia
    Item
    lobular neoplasia.
    boolean
    C0861352 (UMLS CUI [1])
    Atypical ductal hyperplasia
    Item
    atypical ductal hyperplasia.
    boolean
    C0442834 (UMLS CUI [1])
    Prior Therapy Noninfiltrating Intraductal Carcinoma | First line treatment Complete | Hormone Therapy
    Item
    ductal carcinoma in situ (dcis) that has been previously treated. patients must be at least 2 months from completion of primary therapy, and if treated with hormonal therapy, they must have completed at least two months of hormonal therapy.
    boolean
    C1514463 (UMLS CUI [1,1])
    C0007124 (UMLS CUI [1,2])
    C1708063 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C0279025 (UMLS CUI [3])
    BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation | Risk Assessment BRCAPRO | BRCA1 gene mutation | BRCA2 gene mutation
    Item
    deleterious mutations in brca-1 or 2 or a priori risk assessment of 20 percent chance or greater of carrying a brca1/2 gene mutation. the brcapro model (109) will be used to assess this risk.
    boolean
    C0376571 (UMLS CUI [1,1])
    C2985436 (UMLS CUI [1,2])
    C0598034 (UMLS CUI [2,1])
    C2985436 (UMLS CUI [2,2])
    C0086930 (UMLS CUI [3,1])
    C1879774 (UMLS CUI [3,2])
    C1511022 (UMLS CUI [4])
    C1511024 (UMLS CUI [5])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Pregnancy, Planned | Childbearing Potential | Postmenopausal state | Hysterectomy | Ovariectomy | Tubal Ligation | Pregnancy Test
    Item
    currently pregnant or planning to become pregnant during the study period. pregnancy will be assessed in women of childbearing potential prior to enrolling in stage ii of the study. postmenopausal women and women who have had a previous hysterectomy, oophorectomy or tubal ligation will not be required to undergo a pregnancy test.
    boolean
    C0032961 (UMLS CUI [1])
    C0032992 (UMLS CUI [2])
    C3831118 (UMLS CUI [3])
    C0232970 (UMLS CUI [4])
    C0020699 (UMLS CUI [5])
    C0029936 (UMLS CUI [6])
    C0520483 (UMLS CUI [7])
    C0032976 (UMLS CUI [8])
    Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Recent myocardial infarction | Cerebrovascular accident Recent | Mental disorder Compliance behavior Limited | social situation Compliance behavior Limited
    Item
    uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recent myocardial infarction or stroke, or psychiatric illness/social situations that would limit compliance with study requirements.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0009450 (UMLS CUI [2])
    C0742758 (UMLS CUI [3])
    C0002965 (UMLS CUI [4])
    C0003811 (UMLS CUI [5])
    C1998297 (UMLS CUI [6])
    C0038454 (UMLS CUI [7,1])
    C0332185 (UMLS CUI [7,2])
    C0004936 (UMLS CUI [8,1])
    C1321605 (UMLS CUI [8,2])
    C0439801 (UMLS CUI [8,3])
    C0748872 (UMLS CUI [9,1])
    C1321605 (UMLS CUI [9,2])
    C0439801 (UMLS CUI [9,3])
    Physical Condition Exclusion Walking Daily Quantity | Requirement Study Protocol | Arthritis Severe | Walker user | Cane user | Wheelchair bound
    Item
    physical conditions that preclude the amount of daily walking prescribed by the protocol (e.g., severe arthritis, use of a walker or cane, wheelchair-bound, etc.).
    boolean
    C3714565 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    C0080331 (UMLS CUI [1,3])
    C0332173 (UMLS CUI [1,4])
    C1265611 (UMLS CUI [1,5])
    C1514873 (UMLS CUI [2,1])
    C2348563 (UMLS CUI [2,2])
    C0003864 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    C0920121 (UMLS CUI [4])
    C0920240 (UMLS CUI [5])
    C0558195 (UMLS CUI [6])
    Disease Informed Consent Unable | Mental disorder Informed Consent Unable
    Item
    medical or psychiatric disorder which would, in the opinion of the principal investigator, render the subject unable to provide informed consent.
    boolean
    C0012634 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
    C0004936 (UMLS CUI [2,1])
    C0021430 (UMLS CUI [2,2])
    C1299582 (UMLS CUI [2,3])
    Metastatic Neoplasm | Recurrent disease | research results Interpretation Difficult | Gender | Chemotherapy
    Item
    patients with metastatic or recurrent disease will be excluded because of difficulty interpreting results in the context of women with a disease burden and/or on chemotherapy.
    boolean
    C2939420 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    C0683954 (UMLS CUI [3,1])
    C0459471 (UMLS CUI [3,2])
    C0332218 (UMLS CUI [3,3])
    C0079399 (UMLS CUI [4])
    C0392920 (UMLS CUI [5])

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