ID

38027

Beschrijving

Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01495650

Link

https://clinicaltrials.gov/show/NCT01495650

Trefwoorden

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

See clinicaltrials.gov

Geüploaded op

9 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01495650

Engels

Eligibility Breast Cancer NCT01495650

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patient with histologically proven breast cancer
Beschrijving

Gender | Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
18-76 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 fec100, or 3fec100 + taxanes) followed by radiotherapy
Beschrijving

Curative Surgery | Eligibility Chemotherapy cycle Adjuvant Quantity | taxane | Followed by Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C1511562
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C1302181
UMLS CUI [2,3]
C1522673
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0215136
UMLS CUI [4,1]
C0332283
UMLS CUI [4,2]
C1522449
satisfactory healing of breast and lymph nodes area
Beschrijving

Healing Breast | Healing Lymph node Area

Datatype

boolean

Alias
UMLS CUI [1,1]
C0043240
UMLS CUI [1,2]
C0006141
UMLS CUI [2,1]
C0043240
UMLS CUI [2,2]
C0024204
UMLS CUI [2,3]
C0205146
ability to understand the nature, goal and study methodology
Beschrijving

Comprehension Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
consent to cooperate for clinical assessments
Beschrijving

Compliance Clinical assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C4534461
affiliation to a social security regime or beneficiary of equivalent social protection
Beschrijving

Affiliation Social Security Program | Beneficiary Social Protection Equivalent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1510825
UMLS CUI [1,2]
C0037435
UMLS CUI [2,1]
C1550502
UMLS CUI [2,2]
C0242457
UMLS CUI [2,3]
C0205163
written informed consent provided before any study specific procedures
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
her2 positive or metastatic cancer
Beschrijving

Carcinoma HER2 Positive | Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007097
UMLS CUI [1,2]
C2348909
UMLS CUI [2]
C0027627
any other primary tumor
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
contraindication to moderate physical activity
Beschrijving

Medical contraindication Moderate physical activity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C4482418
contraindication to adjuvant chemotherapy or radiotherapy
Beschrijving

Medical contraindication Adjuvant Chemotherapy | Medical contraindication Adjuvant Radiotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085533
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0242939
pregnancy or breast feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial
Beschrijving

Compliance Intervention Unable | Compliance Follow-up Unable | Disability Preventing Comprehension Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0231170
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0162340
UMLS CUI [3,4]
C0008976
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Similar models

Eligibility Breast Cancer NCT01495650

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma
Item
female patient with histologically proven breast cancer
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Age
Item
18-76 years old
boolean
C0001779 (UMLS CUI [1])
Curative Surgery | Eligibility Chemotherapy cycle Adjuvant Quantity | taxane | Followed by Therapeutic radiology procedure
Item
patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 fec100, or 3fec100 + taxanes) followed by radiotherapy
boolean
C1511562 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C1302181 (UMLS CUI [2,2])
C1522673 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0215136 (UMLS CUI [3])
C0332283 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
Healing Breast | Healing Lymph node Area
Item
satisfactory healing of breast and lymph nodes area
boolean
C0043240 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C0043240 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C0205146 (UMLS CUI [2,3])
Comprehension Study Protocol
Item
ability to understand the nature, goal and study methodology
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Compliance Clinical assessment
Item
consent to cooperate for clinical assessments
boolean
C1321605 (UMLS CUI [1,1])
C4534461 (UMLS CUI [1,2])
Affiliation Social Security Program | Beneficiary Social Protection Equivalent
Item
affiliation to a social security regime or beneficiary of equivalent social protection
boolean
C1510825 (UMLS CUI [1,1])
C0037435 (UMLS CUI [1,2])
C1550502 (UMLS CUI [2,1])
C0242457 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Informed Consent
Item
written informed consent provided before any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Carcinoma HER2 Positive | Neoplasm Metastasis
Item
her2 positive or metastatic cancer
boolean
C0007097 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
Cancer Other
Item
any other primary tumor
boolean
C1707251 (UMLS CUI [1])
Medical contraindication Moderate physical activity
Item
contraindication to moderate physical activity
boolean
C1301624 (UMLS CUI [1,1])
C4482418 (UMLS CUI [1,2])
Medical contraindication Adjuvant Chemotherapy | Medical contraindication Adjuvant Radiotherapy
Item
contraindication to adjuvant chemotherapy or radiotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0242939 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Compliance Intervention Unable | Compliance Follow-up Unable | Disability Preventing Comprehension Clinical Trial
Item
inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial
boolean
C1321605 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0231170 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
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