ID

38122

Beschrijving

Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase; ODM derived from: https://clinicaltrials.gov/show/NCT01795612

Link

https://clinicaltrials.gov/show/NCT01795612

Trefwoorden

Versies (1)
  1. 19-09-19 19-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01795612

Engels

Eligibility Breast Cancer NCT01795612

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
females between 18 and 75 years of age;
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
signed written informed consent;
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
willing to take part in the trial and to follow the instructions;
Beschrijving

Study Subject Participation Status Willing | Adherence Instructions

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C1442085
breast tumour, histologically documented;
Beschrijving

Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
patients for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3fec100 +3 taxanes or 6 fec) +/- radiotherapy+/- herceptin has been scheduled;
Beschrijving

Scheduled treatment | Adjuvant Chemotherapy Quantity | Neoadjuvant Chemotherapy Quantity | FEC | Taxanes | Therapeutic radiology procedure | Therapeutic radiology procedure Absent | Herceptin | Herceptin Absent

Datatype

boolean

Alias
UMLS CUI [1]
C3844437
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C3665472
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0060133
UMLS CUI [5]
C0796419
UMLS CUI [6]
C1522449
UMLS CUI [7,1]
C1522449
UMLS CUI [7,2]
C0332197
UMLS CUI [8]
C0338204
UMLS CUI [9,1]
C0338204
UMLS CUI [9,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic cancer;
Beschrijving

Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
disability preventing a proper understanding of the instructions for the trial;
Beschrijving

Disability Preventing Comprehension Instructions

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C1442085
patients who are subject to a court protection, wardship or guardianship order;
Beschrijving

Court of protection certificate status | Patients Wardship | Patients Guardianship

Datatype

boolean

Alias
UMLS CUI [1]
C0585789
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0556263
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0870627
uncontrolled hypertension;
Beschrijving

Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
family history of sudden death in a first-degree relative;
Beschrijving

Family history of sudden death First Degree Relative

Datatype

boolean

Alias
UMLS CUI [1,1]
C2315244
UMLS CUI [1,2]
C1517194
unstabilised heart disease;
Beschrijving

Heart Disease Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0443343
current treatment with beta-blockers;
Beschrijving

Adrenergic beta-1 Receptor Antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C0304516
chronic or acute pulmonary disease associated with dyspnoea upon moderate effort;
Beschrijving

Chronic lung disease | Lung disease Associated with Dyspnea on exertion | Dyspnea Effort Moderate

Datatype

boolean

Alias
UMLS CUI [1]
C0746102
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0231807
UMLS CUI [3,1]
C0013404
UMLS CUI [3,2]
C0015264
UMLS CUI [3,3]
C0205081
uncontrolled thyroid dysfunction;
Beschrijving

Thyroid dysfunction Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348024
UMLS CUI [1,2]
C0205318
uncontrolled diabetes;
Beschrijving

Diabetic - poor control

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
any other serious conditions that are unstabilised,
Beschrijving

Condition Serious Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
disabling or in which physical exercise is contra-indicated;
Beschrijving

Disabling condition | Physical exercise Contraindicated

Datatype

boolean

Alias
UMLS CUI [1]
C4061999
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C1444657
unable to attend for follow-up throughout the duration of the study;
Beschrijving

Follow-up Attend Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C1299582
ventricular ejection fraction (vef) < 50%, pregnancy or suckling.
Beschrijving

Ventricular Ejection Fraction | Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0042508
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
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Similar models

Eligibility Breast Cancer NCT01795612

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
females between 18 and 75 years of age;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
signed written informed consent;
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status Willing | Adherence Instructions
Item
willing to take part in the trial and to follow the instructions;
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C1510802 (UMLS CUI [2,1])
C1442085 (UMLS CUI [2,2])
Breast Carcinoma
Item
breast tumour, histologically documented;
boolean
C0678222 (UMLS CUI [1])
Scheduled treatment | Adjuvant Chemotherapy Quantity | Neoadjuvant Chemotherapy Quantity | FEC | Taxanes | Therapeutic radiology procedure | Therapeutic radiology procedure Absent | Herceptin | Herceptin Absent
Item
patients for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3fec100 +3 taxanes or 6 fec) +/- radiotherapy+/- herceptin has been scheduled;
boolean
C3844437 (UMLS CUI [1])
C0085533 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0600558 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0060133 (UMLS CUI [4])
C0796419 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
C1522449 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0338204 (UMLS CUI [8])
C0338204 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
metastatic cancer;
boolean
C0027627 (UMLS CUI [1])
Disability Preventing Comprehension Instructions
Item
disability preventing a proper understanding of the instructions for the trial;
boolean
C0231170 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C1442085 (UMLS CUI [1,4])
Court of protection certificate status | Patients Wardship | Patients Guardianship
Item
patients who are subject to a court protection, wardship or guardianship order;
boolean
C0585789 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0556263 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0870627 (UMLS CUI [3,2])
Uncontrolled hypertension
Item
uncontrolled hypertension;
boolean
C1868885 (UMLS CUI [1])
Family history of sudden death First Degree Relative
Item
family history of sudden death in a first-degree relative;
boolean
C2315244 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
Heart Disease Unstable
Item
unstabilised heart disease;
boolean
C0018799 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Adrenergic beta-1 Receptor Antagonists
Item
current treatment with beta-blockers;
boolean
C0304516 (UMLS CUI [1])
Chronic lung disease | Lung disease Associated with Dyspnea on exertion | Dyspnea Effort Moderate
Item
chronic or acute pulmonary disease associated with dyspnoea upon moderate effort;
boolean
C0746102 (UMLS CUI [1])
C0024115 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0231807 (UMLS CUI [2,3])
C0013404 (UMLS CUI [3,1])
C0015264 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
Thyroid dysfunction Uncontrolled
Item
uncontrolled thyroid dysfunction;
boolean
C0348024 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Diabetic - poor control
Item
uncontrolled diabetes;
boolean
C0421258 (UMLS CUI [1])
Condition Serious Unstable
Item
any other serious conditions that are unstabilised,
boolean
C0348080 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
Disabling condition | Physical exercise Contraindicated
Item
disabling or in which physical exercise is contra-indicated;
boolean
C4061999 (UMLS CUI [1])
C0015259 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
Follow-up Attend Unable
Item
unable to attend for follow-up throughout the duration of the study;
boolean
C3274571 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Ventricular Ejection Fraction | Pregnancy | Breast Feeding
Item
ventricular ejection fraction (vef) < 50%, pregnancy or suckling.
boolean
C0042508 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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