ID

38185

Beskrivning

Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02117011

Länk

https://clinicaltrials.gov/show/NCT02117011

Nyckelord

Versioner (1)
  1. 2019-09-25 2019-09-25 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02117011

Engelsk

Eligibility Breast Cancer NCT02117011

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
-over 18 years old or less than 75 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed carcinoma of the breast
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
radiation therapy naive
Beskrivning

Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
sedentary, as defined as <60 minutes of recreation or work requiring modest pa/week based on the 7 day physical activity recall questionnaire
Beskrivning

Sedentary lifestyle | Moderate physical activity Duration per week | Physical activity questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C1532253
UMLS CUI [2,1]
C4482418
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0332174
UMLS CUI [3]
C4264334
ambulatory
Beskrivning

Ambulatory

Datatyp

boolean

Alias
UMLS CUI [1]
C0439841
negative serum pregnancy test and not planning to be pregnant in the next 3 months
Beskrivning

Serum pregnancy test negative | Absence Planned Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0430061
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0032992
ability to understand and the willingness to sign a written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
have breast cancer stage 0-iiia
Beskrivning

Breast Carcinoma TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
completed neo-adjuvant or adjuvant chemotherapy may be concurrently receiving endocrine or her2 directed therapy
Beskrivning

Neoadjuvant Chemotherapy Completed | Adjuvant Chemotherapy Completed | Hormone Therapy | HER2 Targeted Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0279025
UMLS CUI [4,1]
C0069515
UMLS CUI [4,2]
C2985566
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 18 years old or more than 75 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
no histological confirmation of breast cancer
Beskrivning

Histology Lacking Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0678222
prior breast, chest or pelvic radiotherapy
Beskrivning

Prior radiation therapy Breast | Prior radiation therapy Chest | Prior radiation therapy Pelvis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0006141
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0817096
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0030797
concurrent chemotherapy
Beskrivning

Chemotherapy Concurrent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
distant metastases
Beskrivning

Distant metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C1269798
physical limitations (e.g., orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking program
Beskrivning

Physical disability | Orthopedic problem | CNS problem | Medical contraindication Walking With intensity low | Medical contraindication Walking Moderate intensity

Datatyp

boolean

Alias
UMLS CUI [1]
C0520817
UMLS CUI [2]
C0029354
UMLS CUI [3]
C0740760
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0080331
UMLS CUI [4,3]
C0522510
UMLS CUI [4,4]
C0205251
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0080331
UMLS CUI [5,3]
C4081855
a positive pregnancy test, currently pregnant or planning to become pregnant in the next three months
Beskrivning

Pregnancy test positive | Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0240802
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
identified as the active or maintenance stage of exercise behavior
Beskrivning

Active physical exercise | Maintenance stage Exercise

Datatyp

boolean

Alias
UMLS CUI [1]
C0336917
UMLS CUI [2,1]
C1277193
UMLS CUI [2,2]
C0015259
psychiatric disorder which would render the subject unable to provide informed consent.
Beskrivning

Mental disorder | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Breast Cancer NCT02117011

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
-over 18 years old or less than 75 years old.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma
Item
histologically confirmed carcinoma of the breast
boolean
C0678222 (UMLS CUI [1])
Therapeutic radiology procedure Absent
Item
radiation therapy naive
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Sedentary lifestyle | Moderate physical activity Duration per week | Physical activity questionnaire
Item
sedentary, as defined as <60 minutes of recreation or work requiring modest pa/week based on the 7 day physical activity recall questionnaire
boolean
C1532253 (UMLS CUI [1])
C4482418 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
C4264334 (UMLS CUI [3])
Ambulatory
Item
ambulatory
boolean
C0439841 (UMLS CUI [1])
Serum pregnancy test negative | Absence Planned Pregnancy
Item
negative serum pregnancy test and not planning to be pregnant in the next 3 months
boolean
C0430061 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0032992 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
have breast cancer stage 0-iiia
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Neoadjuvant Chemotherapy Completed | Adjuvant Chemotherapy Completed | Hormone Therapy | HER2 Targeted Therapy
Item
completed neo-adjuvant or adjuvant chemotherapy may be concurrently receiving endocrine or her2 directed therapy
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3])
C0069515 (UMLS CUI [4,1])
C2985566 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age less than 18 years old or more than 75 years
boolean
C0001779 (UMLS CUI [1])
Histology Lacking Breast Carcinoma
Item
no histological confirmation of breast cancer
boolean
C0344441 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Prior radiation therapy Breast | Prior radiation therapy Chest | Prior radiation therapy Pelvis
Item
prior breast, chest or pelvic radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0030797 (UMLS CUI [3,2])
Chemotherapy Concurrent
Item
concurrent chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
Distant metastasis
Item
distant metastases
boolean
C1269798 (UMLS CUI [1])
Physical disability | Orthopedic problem | CNS problem | Medical contraindication Walking With intensity low | Medical contraindication Walking Moderate intensity
Item
physical limitations (e.g., orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking program
boolean
C0520817 (UMLS CUI [1])
C0029354 (UMLS CUI [2])
C0740760 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0080331 (UMLS CUI [4,2])
C0522510 (UMLS CUI [4,3])
C0205251 (UMLS CUI [4,4])
C1301624 (UMLS CUI [5,1])
C0080331 (UMLS CUI [5,2])
C4081855 (UMLS CUI [5,3])
Pregnancy test positive | Pregnancy | Pregnancy, Planned
Item
a positive pregnancy test, currently pregnant or planning to become pregnant in the next three months
boolean
C0240802 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Active physical exercise | Maintenance stage Exercise
Item
identified as the active or maintenance stage of exercise behavior
boolean
C0336917 (UMLS CUI [1])
C1277193 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
Mental disorder | Informed Consent Unable
Item
psychiatric disorder which would render the subject unable to provide informed consent.
boolean
C0004936 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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