ID

38224

Beskrivning

The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02167932

Länk

https://clinicaltrials.gov/show/NCT02167932

Nyckelord

Versioner (1)
  1. 2019-09-29 2019-09-29 -
Rättsinnehavare

See clinicatrials.gov

Uppladdad den

29 september 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT02167932

Engelsk

Eligibility Breast Cancer NCT02167932

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
21 to 59 years of age, female (a similar trial lccc 1226 explores physical activity in women 60 years and older and is now in progress.
Beskrivning

Age | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
histologically confirmed stage i, ii or iii breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
Beskrivning

Breast Carcinoma TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by nccn guidelines (www.nccn.org). patients receiving anti-her-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
Beskrivning

Adjuvant Chemotherapy Scheduled | Neoadjuvant Chemotherapy Scheduled | Targeted Therapy HER2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0069515
english speaking
Beskrivning

Able to speak English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
irb approved, signed written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
approval from their treating physician to engage in moderate-intensity physical activity
Beskrivning

Physician Approval | Patient Engagement Moderate physical activity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0205540
UMLS CUI [2,1]
C3508152
UMLS CUI [2,2]
C4482418
patient-assessed ability to walk and engage in moderate physical activity
Beskrivning

Able to walk | Patient Engagement Moderate physical activity

Datatyp

boolean

Alias
UMLS CUI [1]
C2712089
UMLS CUI [2,1]
C3508152
UMLS CUI [2,2]
C4482418
willing and able to meet all study requirements.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
one or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
Beskrivning

Medical condition Excludes Walking | Medical condition Excludes Strength Training

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0080331
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0872279
unable to walk or engage in moderate-intensity physical activity.
Beskrivning

Lacking Able to walk | Engagement Moderate physical activity Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [2,1]
C3508152
UMLS CUI [2,2]
C4482418
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Breast Cancer NCT02167932

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender
Item
21 to 59 years of age, female (a similar trial lccc 1226 explores physical activity in women 60 years and older and is now in progress.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Breast Carcinoma TNM Breast tumor staging
Item
histologically confirmed stage i, ii or iii breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Adjuvant Chemotherapy Scheduled | Neoadjuvant Chemotherapy Scheduled | Targeted Therapy HER2
Item
scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by nccn guidelines (www.nccn.org). patients receiving anti-her-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
boolean
C0085533 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C2985566 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
Able to speak English Language
Item
english speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed Consent
Item
irb approved, signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Physician Approval | Patient Engagement Moderate physical activity
Item
approval from their treating physician to engage in moderate-intensity physical activity
boolean
C0031831 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C3508152 (UMLS CUI [2,1])
C4482418 (UMLS CUI [2,2])
Able to walk | Patient Engagement Moderate physical activity
Item
patient-assessed ability to walk and engage in moderate physical activity
boolean
C2712089 (UMLS CUI [1])
C3508152 (UMLS CUI [2,1])
C4482418 (UMLS CUI [2,2])
Protocol Compliance
Item
willing and able to meet all study requirements.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical condition Excludes Walking | Medical condition Excludes Strength Training
Item
one or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0872279 (UMLS CUI [2,3])
Lacking Able to walk | Engagement Moderate physical activity Unable
Item
unable to walk or engage in moderate-intensity physical activity.
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C3508152 (UMLS CUI [2,1])
C4482418 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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