UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031818 |
|---|---|
| Receipt number | 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 20:10:44 |
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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
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
kimurahi@mad.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School Of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036341
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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