ID

35101

Beschrijving

EXercise Influence on Taxane Side Effects (EXIT) Study; ODM derived from: https://clinicaltrials.gov/show/NCT02473861

Link

https://clinicaltrials.gov/show/NCT02473861

Trefwoorden

  1. 17-02-19 17-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 februari 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT02473861

Eligibility Breast Neoplasms NCT02473861

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
born female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
age 19 or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed stage i-iiia breast cancer diagnosis
Beschrijving

Breast Carcinoma TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
scheduled to receive neoadjuvant or adjuvant taxane-containing chemotherapy
Beschrijving

Chemotherapy Neoadjuvant Scheduled | Adjuvant Chemotherapy Scheduled | taxane

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1298676
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0205539
UMLS CUI [3]
C0215136
willing and able to attend baseline assessment prior to first taxane-containing treatment
Beschrijving

Baseline Assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1516048
have reliable transportation to attend our exercise gym located near the vancouver bcca three times weekly for 8-13 weeks
Beschrijving

Exercise Frequency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0439603
be able to read and communicate in english
Beschrijving

Able to read English Language | Able to communicate English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C2364293
UMLS CUI [2,2]
C0376245
treating medical oncologist approval to participate
Beschrijving

Study Subject Participation Status Oncologist Approval

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0259990
UMLS CUI [1,3]
C0205540
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
receipt of further chemotherapy treatments after taxane-containing treatments
Beschrijving

Chemotherapy Additional | Status post Taxane Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0215136
UMLS CUI [2,3]
C0087111
stage iv cancer
Beschrijving

Malignant Neoplasm TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3258246
acute or uncontrolled health conditions including heart disease, respiratory disease (copd or severe asthma)
Beschrijving

Medical condition | Medical condition Uncontrolled | Heart Disease | Respiration Disorder | Chronic Obstructive Airway Disease | Severe asthma

Datatype

boolean

Alias
UMLS CUI [1]
C3843040
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0024117
UMLS CUI [6]
C0581126
diagnosis of diabetes at any time
Beschrijving

Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
personal history of neurological disorder
Beschrijving

Nervous system disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0027765
mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (includes orthopedic injury or arthritis that result in inability to exercise)
Beschrijving

Impaired mobility Requirement Mobility aid | Impaired mobility Preventing Exercise | Injury orthopedic | Arthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0518456
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C3495449
UMLS CUI [2,1]
C0518456
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0015259
UMLS CUI [3,1]
C3263723
UMLS CUI [3,2]
C0029355
UMLS CUI [4]
C0003864
body mass index ≥40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
previously received chemotherapy or thoracic radiation treatment
Beschrijving

Prior Chemotherapy | Radiotherapy to thorax Previous

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C4038705
UMLS CUI [2,2]
C0205156

Similar models

Eligibility Breast Neoplasms NCT02473861

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
born female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 19 or older
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
histologically confirmed stage i-iiia breast cancer diagnosis
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Chemotherapy Neoadjuvant Scheduled | Adjuvant Chemotherapy Scheduled | taxane
Item
scheduled to receive neoadjuvant or adjuvant taxane-containing chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0215136 (UMLS CUI [3])
Baseline Assessment
Item
willing and able to attend baseline assessment prior to first taxane-containing treatment
boolean
C1442488 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Exercise Frequency
Item
have reliable transportation to attend our exercise gym located near the vancouver bcca three times weekly for 8-13 weeks
boolean
C0015259 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Able to read English Language | Able to communicate English Language
Item
be able to read and communicate in english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Study Subject Participation Status Oncologist Approval
Item
treating medical oncologist approval to participate
boolean
C2348568 (UMLS CUI [1,1])
C0259990 (UMLS CUI [1,2])
C0205540 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Additional | Status post Taxane Treatment
Item
receipt of further chemotherapy treatments after taxane-containing treatments
boolean
C0392920 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0215136 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Malignant Neoplasm TNM clinical staging
Item
stage iv cancer
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Medical condition | Medical condition Uncontrolled | Heart Disease | Respiration Disorder | Chronic Obstructive Airway Disease | Severe asthma
Item
acute or uncontrolled health conditions including heart disease, respiratory disease (copd or severe asthma)
boolean
C3843040 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0024117 (UMLS CUI [5])
C0581126 (UMLS CUI [6])
Diabetes Mellitus
Item
diagnosis of diabetes at any time
boolean
C0011849 (UMLS CUI [1])
Nervous system disorder
Item
personal history of neurological disorder
boolean
C0027765 (UMLS CUI [1])
Impaired mobility Requirement Mobility aid | Impaired mobility Preventing Exercise | Injury orthopedic | Arthritis
Item
mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (includes orthopedic injury or arthritis that result in inability to exercise)
boolean
C0518456 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3495449 (UMLS CUI [1,3])
C0518456 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0015259 (UMLS CUI [2,3])
C3263723 (UMLS CUI [3,1])
C0029355 (UMLS CUI [3,2])
C0003864 (UMLS CUI [4])
Body mass index
Item
body mass index ≥40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Prior Chemotherapy | Radiotherapy to thorax Previous
Item
previously received chemotherapy or thoracic radiation treatment
boolean
C1514457 (UMLS CUI [1])
C4038705 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])

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