ID

15480

Descripción

Standard Care Alone or With Acupuncture for CIPN in Metastatic Breast Cancer and Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02275403

Link

https://clinicaltrials.gov/show/NCT02275403

Palabras clave

Versiones (1)
  1. 1/6/16 1/6/16 -
Subido en

1 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT02275403

Inglés

Eligibility Metastatic Breast Cancer NCT02275403

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with metastatic breast cancer or multiple myeloma who are receiving or who have received neurotoxic chemotherapy treatment for their condition
Descripción

Carcinoma breast stage IV | Multiple Myeloma | Chemotherapy Regimen Neurotoxic agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C0026764
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0260049
the capacity to understand the patient information sheet and the ability to give written informed consent
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
willingness and ability to comply with scheduled visits and study procedures, including the self-report qol questionnaires
Descripción

Compliance behavior Study Protocol Quality of life scale

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0451401
age ≥ 18 years; no upper age limit
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
cipn of ≥ grade ii (ctcae v4.03)
Descripción

CIPN | CTCAE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3873567
UMLS CUI [2]
C3888020
platelet count of ≥ 30 x 10*9/l
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
neutrophil count of ≥ 0.5 x 10*9/l
Descripción

Neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
mymop2 score of their most troubling cipn symptom ≥ 3
Descripción

Score | CIPN Symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0449820
UMLS CUI [2,1]
C3873567
UMLS CUI [2,2]
C1457887
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have previously received acupuncture for neuropathy
Descripción

Acupuncture Neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0394664
UMLS CUI [1,2]
C0442874
patients who have received acupuncture for any indication, other than neuropathy, within the previous 6 months
Descripción

Acupuncture Indication | Neuropathy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0394664
UMLS CUI [1,2]
C3146298
UMLS CUI [2]
C0442874
women who are pregnant or breast feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
co-morbidity with a bleeding disorder
Descripción

Comorbidity | Blood Coagulation Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0005779
patients with an aversion to needles
Descripción

Aversion Needles

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0233496
UMLS CUI [1,2]
C0027551
abnormal coagulation profile: international normalised ratio (inr) > 5
Descripción

Abnormal coagulation profile | INR

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0375576
UMLS CUI [2]
C0525032
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Similar models

Eligibility Metastatic Breast Cancer NCT02275403

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma breast stage IV | Multiple Myeloma | Chemotherapy Regimen Neurotoxic agents
Item
patients with metastatic breast cancer or multiple myeloma who are receiving or who have received neurotoxic chemotherapy treatment for their condition
boolean
C0278488 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0260049 (UMLS CUI [3,2])
Informed consent
Item
the capacity to understand the patient information sheet and the ability to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Study Protocol Quality of life scale
Item
willingness and ability to comply with scheduled visits and study procedures, including the self-report qol questionnaires
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0451401 (UMLS CUI [1,3])
Age
Item
age ≥ 18 years; no upper age limit
boolean
C0001779 (UMLS CUI [1])
CIPN | CTCAE
Item
cipn of ≥ grade ii (ctcae v4.03)
boolean
C3873567 (UMLS CUI [1])
C3888020 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count of ≥ 30 x 10*9/l
boolean
C0032181 (UMLS CUI [1])
Neutrophil count
Item
neutrophil count of ≥ 0.5 x 10*9/l
boolean
C0200633 (UMLS CUI [1])
Score | CIPN Symptoms
Item
mymop2 score of their most troubling cipn symptom ≥ 3
boolean
C0449820 (UMLS CUI [1])
C3873567 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Acupuncture Neuropathy
Item
patients who have previously received acupuncture for neuropathy
boolean
C0394664 (UMLS CUI [1,1])
C0442874 (UMLS CUI [1,2])
Acupuncture Indication | Neuropathy
Item
patients who have received acupuncture for any indication, other than neuropathy, within the previous 6 months
boolean
C0394664 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0442874 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity | Blood Coagulation Disorders
Item
co-morbidity with a bleeding disorder
boolean
C0009488 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Aversion Needles
Item
patients with an aversion to needles
boolean
C0233496 (UMLS CUI [1,1])
C0027551 (UMLS CUI [1,2])
Abnormal coagulation profile | INR
Item
abnormal coagulation profile: international normalised ratio (inr) > 5
boolean
C0375576 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
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