ID

38211

Beskrivning

The Effect of Walking on Fatigue During Radiotherapy in Breast Cancer Patients 65 and Older; ODM derived from: https://clinicaltrials.gov/show/NCT02434367

Länk

https://clinicaltrials.gov/show/NCT02434367

Nyckelord

Versioner (1)
  1. 2019-09-27 2019-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02434367

Engelsk

Eligibility Breast Cancer NCT02434367

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥65 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed stage i, ii or iii breast cancer status post breast surgery with or without adjuvant chemotherapy.
Beskrivning

Breast Carcinoma TNM Breast tumor staging | Status post Operation on breast | Chemotherapy, Adjuvant | Adjuvant Chemotherapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C3714726
UMLS CUI [3]
C0085533
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C0332197
scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall.
Beskrivning

Hypofractionated radiation therapy Scheduled | Radiotherapy to breast Fractionated Scheduled | Radiotherapy to chest wall Fractionated Scheduled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1831786
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0948310
UMLS CUI [2,2]
C1979893
UMLS CUI [2,3]
C0205539
UMLS CUI [3,1]
C1998066
UMLS CUI [3,2]
C1979893
UMLS CUI [3,3]
C0205539
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 radiation oncologist to engage in moderate-intensity physical activity. this will be obtained by the study research coordinator and documented on the study screening form (attached).
Beskrivning

Moderate physical activity

Datatyp

boolean

Alias
UMLS CUI [1]
C4482418
patient-assessed ability to walk and engage in moderate physical activity willing and able to meet all study requirements.
Beskrivning

Able to walk | Moderate physical activity | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C2712089
UMLS CUI [2]
C4482418
UMLS CUI [3]
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 intervention.
Beskrivning

Medical condition Excludes Walking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0080331
receiving accelerated partial breast irradiation.
Beskrivning

Accelerated Partial Breast Irradiation

Datatyp

boolean

Alias
UMLS CUI [1]
C3896696
unable to walk or engage in moderate-intensity physical activity.
Beskrivning

Lacking Able to walk | Moderate physical activity Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [2,1]
C4482418
UMLS CUI [2,2]
C1299582
already participated in walk with ease program.
Beskrivning

Participation Walking Program Easy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0080331
UMLS CUI [1,3]
C3484370
UMLS CUI [1,4]
C0332219
already actively walking (≥120 minutes per week).
Beskrivning

Walking minutes per week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0080331
UMLS CUI [1,2]
C0556975
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Similar models

Eligibility Breast Cancer NCT02434367

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥65 years of age
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging | Status post Operation on breast | Chemotherapy, Adjuvant | Adjuvant Chemotherapy Absent
Item
histologically confirmed stage i, ii or iii breast cancer status post breast surgery with or without adjuvant chemotherapy.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C3714726 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
C0085533 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hypofractionated radiation therapy Scheduled | Radiotherapy to breast Fractionated Scheduled | Radiotherapy to chest wall Fractionated Scheduled
Item
scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall.
boolean
C1831786 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0948310 (UMLS CUI [2,1])
C1979893 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C1998066 (UMLS CUI [3,1])
C1979893 (UMLS CUI [3,2])
C0205539 (UMLS CUI [3,3])
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])
Moderate physical activity
Item
approval from their treating radiation oncologist to engage in moderate-intensity physical activity. this will be obtained by the study research coordinator and documented on the study screening form (attached).
boolean
C4482418 (UMLS CUI [1])
Able to walk | Moderate physical activity | Protocol Compliance
Item
patient-assessed ability to walk and engage in moderate physical activity willing and able to meet all study requirements.
boolean
C2712089 (UMLS CUI [1])
C4482418 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Medical condition Excludes Walking
Item
one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
Accelerated Partial Breast Irradiation
Item
receiving accelerated partial breast irradiation.
boolean
C3896696 (UMLS CUI [1])
Lacking Able to walk | 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])
C4482418 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Participation Walking Program Easy
Item
already participated in walk with ease program.
boolean
C0679823 (UMLS CUI [1,1])
C0080331 (UMLS CUI [1,2])
C3484370 (UMLS CUI [1,3])
C0332219 (UMLS CUI [1,4])
Walking minutes per week
Item
already actively walking (≥120 minutes per week).
boolean
C0080331 (UMLS CUI [1,1])
C0556975 (UMLS CUI [1,2])
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