ID

38135

Description

Exercising Our ABC's (African- American Breast Cancer Survivors); ODM derived from: https://clinicaltrials.gov/show/NCT01684579

Link

https://clinicaltrials.gov/show/NCT01684579

Keywords

Versions (1)
  1. 9/21/19 9/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01684579

English

Eligibility Breast Cancer NCT01684579

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with a histological confirmation of breast cancer.
Description

Gender | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
age 18 years and older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
stage i-iii. limiting the cohort to stage i-iii cancer limits mortality during the 8-month follow-up period and allows completion of follow-up procedures as well as enhances exercise participation, i.e. no painful bone metastases or danger of pathologic fracture, etc.
Description

Malignant Neoplasm TNM Breast tumor staging | Mortality Limited | Completion Follow-up | Participation Exercise | Secondary malignant neoplasm of bone Absent | Pathological fracture Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0026565
UMLS CUI [2,2]
C0439801
UMLS CUI [3,1]
C0205197
UMLS CUI [3,2]
C3274571
UMLS CUI [4,1]
C0679823
UMLS CUI [4,2]
C0015259
UMLS CUI [5,1]
C0153690
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0016663
UMLS CUI [6,2]
C0332197
eligible patients will include african-american women only.
Description

Gender African American

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0085756
women with recently diagnosed breast cancer who are no more than 12 months after completion of initial therapies including neoadjuvant therapy, surgery, radiation and/or chemotherapy and who are not receiving or scheduled to receive further active cytotoxic therapy other than adjuvant hormonal therapy or targeted therapy. women receiving hormonal therapy or targeted will be eligible to participate in these studies.
Description

Gender | Breast Carcinoma Newly Diagnosed | Completion Therapy Initial | Neoadjuvant Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Cytotoxic Chemotherapy Absent | Exception Hormone Therapy Adjuvant | Exception Targeted Therapy Adjuvant

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1518321
UMLS CUI [3,1]
C0205197
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0205265
UMLS CUI [4]
C0600558
UMLS CUI [5]
C0543467
UMLS CUI [6]
C1522449
UMLS CUI [7]
C0392920
UMLS CUI [8,1]
C0677881
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0279025
UMLS CUI [9,3]
C1522673
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C2985566
UMLS CUI [10,3]
C1522673
eligible patients will include those who meet the criteria for exercise safety as defined in the american heart association and the american college of sports medicine exercise pre-participation questionnaire. all women will require clearance by cardiologist.
Description

Criteria Fulfill Exercise | Definition Exercise Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0015259
UMLS CUI [2,1]
C1704788
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C0034394
eligible patients include the ability to travel to the gathering place, beachwood oh and participate in the new wellness center that is equipped with state-of-the-art aerobic and resistance training apparati.
Description

Ability Travel Wellness Center

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0040802
UMLS CUI [1,3]
C0600622
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
caucasian (non-african-american) and male breast cancer patients.
Description

Caucasians | Gender Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0043157
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0678222
patients who are beyond 12 months after completion of initial therapies for breast cancer, or continuing to receive active therapy including neoadjuvant therapy, surgery, radiation and/or chemotherapy.
Description

Status In the past | Completion Therapy Initial Breast Carcinoma | Neoadjuvant Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0205265
UMLS CUI [2,4]
C0678222
UMLS CUI [3]
C0600558
UMLS CUI [4]
C0543467
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0392920
patients with stage iv disease, severe dementia or life-expectancy less than 6-months.
Description

Disease TNM clinical staging | Severe dementia | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C3494652
UMLS CUI [3]
C0023671
patients will be deemed ineligible if they do not fulfill the criteria for exercise safety as defined in the american heart association and the american college of sports medicine exercise pre-participation questionnaire or do not receive clearance from cardiologist.
Description

Lacking Criteria Fulfill Exercise | Definition Exercise Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C0015259
UMLS CUI [2,1]
C1704788
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C0034394
inability to understand english as the exercise instructors may not be fluent in foreign languages and several of the instruments used to assessment have not been translated into other languages.
Description

Comprehension English Language Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C1299582
inability to travel to the gathering place, beachwood oh and participate in the new wellness center that is equipped with state-of-the-art aerobic and resistance training apparati.(taxi fare to and from the gathering place will be provided where required)
Description

Travel Unable Wellness Center

Data type

boolean

Alias
UMLS CUI [1,1]
C0040802
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0600622
history of connective tissue disorder that would limit exercise.
Description

Connective Tissue Disease Limiting Exercise

Data type

boolean

Alias
UMLS CUI [1,1]
C0009782
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0015259
inability to provide informed consent.
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Breast Cancer NCT01684579

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma
Item
female patients with a histological confirmation of breast cancer.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Age
Item
age 18 years and older.
boolean
C0001779 (UMLS CUI [1])
Malignant Neoplasm TNM Breast tumor staging | Mortality Limited | Completion Follow-up | Participation Exercise | Secondary malignant neoplasm of bone Absent | Pathological fracture Absent
Item
stage i-iii. limiting the cohort to stage i-iii cancer limits mortality during the 8-month follow-up period and allows completion of follow-up procedures as well as enhances exercise participation, i.e. no painful bone metastases or danger of pathologic fracture, etc.
boolean
C0006826 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0026565 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0205197 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0679823 (UMLS CUI [4,1])
C0015259 (UMLS CUI [4,2])
C0153690 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0016663 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Gender African American
Item
eligible patients will include african-american women only.
boolean
C0079399 (UMLS CUI [1,1])
C0085756 (UMLS CUI [1,2])
Gender | Breast Carcinoma Newly Diagnosed | Completion Therapy Initial | Neoadjuvant Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy | Cytotoxic Chemotherapy Absent | Exception Hormone Therapy Adjuvant | Exception Targeted Therapy Adjuvant
Item
women with recently diagnosed breast cancer who are no more than 12 months after completion of initial therapies including neoadjuvant therapy, surgery, radiation and/or chemotherapy and who are not receiving or scheduled to receive further active cytotoxic therapy other than adjuvant hormonal therapy or targeted therapy. women receiving hormonal therapy or targeted will be eligible to participate in these studies.
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
C0205197 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0205265 (UMLS CUI [3,3])
C0600558 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
C0677881 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0279025 (UMLS CUI [9,2])
C1522673 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C2985566 (UMLS CUI [10,2])
C1522673 (UMLS CUI [10,3])
Criteria Fulfill Exercise | Definition Exercise Questionnaire
Item
eligible patients will include those who meet the criteria for exercise safety as defined in the american heart association and the american college of sports medicine exercise pre-participation questionnaire. all women will require clearance by cardiologist.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
C1704788 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
Ability Travel Wellness Center
Item
eligible patients include the ability to travel to the gathering place, beachwood oh and participate in the new wellness center that is equipped with state-of-the-art aerobic and resistance training apparati.
boolean
C0085732 (UMLS CUI [1,1])
C0040802 (UMLS CUI [1,2])
C0600622 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Caucasians | Gender Breast Carcinoma
Item
caucasian (non-african-american) and male breast cancer patients.
boolean
C0043157 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Status In the past | Completion Therapy Initial Breast Carcinoma | Neoadjuvant Therapy | Operative Surgical Procedures | Therapeutic radiology procedure | Chemotherapy
Item
patients who are beyond 12 months after completion of initial therapies for breast cancer, or continuing to receive active therapy including neoadjuvant therapy, surgery, radiation and/or chemotherapy.
boolean
C0449438 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0205197 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0205265 (UMLS CUI [2,3])
C0678222 (UMLS CUI [2,4])
C0600558 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0392920 (UMLS CUI [6])
Disease TNM clinical staging | Severe dementia | Life Expectancy
Item
patients with stage iv disease, severe dementia or life-expectancy less than 6-months.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C3494652 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Lacking Criteria Fulfill Exercise | Definition Exercise Questionnaire
Item
patients will be deemed ineligible if they do not fulfill the criteria for exercise safety as defined in the american heart association and the american college of sports medicine exercise pre-participation questionnaire or do not receive clearance from cardiologist.
boolean
C0332268 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
C1704788 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0034394 (UMLS CUI [2,3])
Comprehension English Language Unable
Item
inability to understand english as the exercise instructors may not be fluent in foreign languages and several of the instruments used to assessment have not been translated into other languages.
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Travel Unable Wellness Center
Item
inability to travel to the gathering place, beachwood oh and participate in the new wellness center that is equipped with state-of-the-art aerobic and resistance training apparati.(taxi fare to and from the gathering place will be provided where required)
boolean
C0040802 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0600622 (UMLS CUI [1,3])
Connective Tissue Disease Limiting Exercise
Item
history of connective tissue disorder that would limit exercise.
boolean
C0009782 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0015259 (UMLS CUI [1,3])
Informed Consent Unable
Item
inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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