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])
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])