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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031818
Receipt No. R000036341
Scientific Title Bio-psycho-social Risk Factors for Delirium and Depression in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Date of disclosure of the study information 2018/03/20
Last modified on 2018/03/20

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Basic information
Public title Bio-psycho-social Risk Factors for Delirium and Depression in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Acronym Psychiatric Symptoms in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Scientific Title Bio-psycho-social Risk Factors for Delirium and Depression in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Scientific Title:Acronym Psychiatric Symptoms in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Region
Japan

Condition
Condition Hematopoietic tumors
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To Determine The Bio-psycho-social Risk Factors for Delirium and Depression in Patients Undergoing Allogeneic Hematopoietic Stem-Cell Transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Delirium Rating Scale -R-98 (DRS-R-98)
Memorial Delirium Assessment Scale (MDAS)
Structured Clinical Interview for DSM-IV (SCID)
Patient Health Questionnaire-9 (PHQ-9)
Key secondary outcomes Hospital Anxiety and Depression Scale (HADS)
Visual Analog Scale (VAS)
36-item Short-Form Health Survey (SF-36)
Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)
Brief Evaluation of Medication Influence and Beliefs (BEMIB)
Social Support Questionnaire (SSQ)
Temperament and Character Inventory-125 (TCI-125)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients To Undergo Allogeneic Hematopoietic Stem-Cell Transplantation In Nagoya Universty Hospital Who Ware Obtained Written Informed Consent After a Full Explanation Of The Study
Key exclusion criteria Patients Who can Not Understand Japanese
Patients Who can Not Understand The Explanation Of The Study With Dementia, Disturbance of Consciousness and Psychiatric Desorders
Patients Who Do Not Consent The Study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Ozaki
Organization Nagoya University Graduate School Of Medicine
Division name Department of Psyichiatry
Zip code
Address Tsyrumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Email ozaki-n@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Kimura
Organization Nagoya University Graduate School Of Medicine
Division name Department of Psyichiatry
Zip code
Address Tsyrumaicho 65, showa-ku, Nagoya City, Aichi, Japan
TEL +81527442282
Homepage URL
Email kimurahi@mad.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School Of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid For Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Longitudinal Model

Management information
Registered date
2018 Year 03 Month 20 Day
Last modified on
2018 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036341

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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