ID

37926

Beskrivning

Intervention Study of Depression in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01256008

Länk

https://clinicaltrials.gov/show/NCT01256008

Nyckelord

Versioner (1)
  1. 2019-08-31 2019-08-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01256008

Engelsk

Eligibility Breast Cancer NCT01256008

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 20-65 years;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
a week after breast cancer surgery;
Beskrivning

Status post Breast Carcinoma Surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0543467
with complaints and symptoms of depression or anxiety
Beskrivning

Complaints Depressive disorder | Symptoms Depressive disorder | Complaints Anxiety | Symptoms Anxiety

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277786
UMLS CUI [1,2]
C0011581
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0011581
UMLS CUI [3,1]
C0277786
UMLS CUI [3,2]
C0003467
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0003467
hamd-17 ≥ 8 points or / and hama ≥ 8 points;
Beskrivning

Hamilton Depression Rating Scale 17 Item | Hamilton Anxiety Rating Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C3541258
have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
Beskrivning

Reading skills | Depression self rating scale Completion

Datatyp

boolean

Alias
UMLS CUI [1]
C0871220
UMLS CUI [2,1]
C0451108
UMLS CUI [2,2]
C0205197
informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous diagnosis of mental disorder or bipolar disorder; alcohol and drug abusing history;
Beskrivning

Mental disorders | Bipolar Disorder | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0038586
use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
Beskrivning

Antidepressive Agents | Antipsychotic Agents | Psychological therapy | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0040615
UMLS CUI [3]
C0841584
UMLS CUI [4]
C2348568
patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
Beskrivning

Cardiovascular Disease | Liver Dysfunction | Renal dysfunction | Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0086565
UMLS CUI [3]
C3279454
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205404
hearing, visual or understanding impairment;
Beskrivning

Hearing impairment | Visual Impairment | Comprehension Impairment

Datatyp

boolean

Alias
UMLS CUI [1]
C1384666
UMLS CUI [2]
C3665347
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C0221099
severe depression, suicidal tendencies;
Beskrivning

Severe depression | Suicidal tendency

Datatyp

boolean

Alias
UMLS CUI [1]
C0588008
UMLS CUI [2]
C0235196
can not or will not comply with clinical treatment programs based on the physicians'
Beskrivning

Treatment Compliance Unable | Treatment Compliance Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4319828
UMLS CUI [2,2]
C0558080
judgment
Beskrivning

ID.14

Datatyp

boolean

exit criteria:
Beskrivning

Discontinuation criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0243161
persons with poor compliance during the trial period;
Beskrivning

Poor compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0032646
persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
Beskrivning

Depressive disorder Increased | Suicidal tendency Serious | Intervention Urgent Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0205217
UMLS CUI [2,1]
C0235196
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0439609
UMLS CUI [3,3]
C1514873
persons who are believed have other circumstances and should be suspended by physicians
Beskrivning

Life circumstances Study Subject Participation Status To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680082
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1272691
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Similar models

Eligibility Breast Cancer NCT01256008

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 20-65 years;
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma
Item
pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
boolean
C0678222 (UMLS CUI [1])
Status post Breast Carcinoma Surgery
Item
a week after breast cancer surgery;
boolean
C0231290 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Complaints Depressive disorder | Symptoms Depressive disorder | Complaints Anxiety | Symptoms Anxiety
Item
with complaints and symptoms of depression or anxiety
boolean
C0277786 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0011581 (UMLS CUI [2,2])
C0277786 (UMLS CUI [3,1])
C0003467 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C0003467 (UMLS CUI [4,2])
Hamilton Depression Rating Scale 17 Item | Hamilton Anxiety Rating Scale Questionnaire
Item
hamd-17 ≥ 8 points or / and hama ≥ 8 points;
boolean
C3639712 (UMLS CUI [1])
C3541258 (UMLS CUI [2])
Reading skills | Depression self rating scale Completion
Item
have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
boolean
C0871220 (UMLS CUI [1])
C0451108 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Bipolar Disorder | Substance Use Disorders
Item
previous diagnosis of mental disorder or bipolar disorder; alcohol and drug abusing history;
boolean
C0004936 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Antidepressive Agents | Antipsychotic Agents | Psychological therapy | Study Subject Participation Status
Item
use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
boolean
C0003289 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0841584 (UMLS CUI [3])
C2348568 (UMLS CUI [4])
Cardiovascular Disease | Liver Dysfunction | Renal dysfunction | Disease Serious
Item
patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
boolean
C0007222 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C3279454 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
Hearing impairment | Visual Impairment | Comprehension Impairment
Item
hearing, visual or understanding impairment;
boolean
C1384666 (UMLS CUI [1])
C3665347 (UMLS CUI [2])
C0162340 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
Severe depression | Suicidal tendency
Item
severe depression, suicidal tendencies;
boolean
C0588008 (UMLS CUI [1])
C0235196 (UMLS CUI [2])
Treatment Compliance Unable | Treatment Compliance Unwilling
Item
can not or will not comply with clinical treatment programs based on the physicians'
boolean
C4319828 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4319828 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
ID.14
Item
judgment
boolean
Discontinuation criteria
Item
exit criteria:
boolean
C1444662 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Poor compliance
Item
persons with poor compliance during the trial period;
boolean
C0032646 (UMLS CUI [1])
Depressive disorder Increased | Suicidal tendency Serious | Intervention Urgent Required
Item
persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
boolean
C0011581 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0235196 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0184661 (UMLS CUI [3,1])
C0439609 (UMLS CUI [3,2])
C1514873 (UMLS CUI [3,3])
Life circumstances Study Subject Participation Status To be stopped
Item
persons who are believed have other circumstances and should be suspended by physicians
boolean
C0680082 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
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