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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000047644
Receipt No. R000054244
Scientific Title Observation study of psychiatric symptoms in patients admitted to sterile rooms with hematopoietic cell transplantation
Date of disclosure of the study information 2022/05/15
Last modified on 2022/05/02

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Basic information
Public title Multicenter collaborative research on psychiatric symptoms of hematopoietic cell transplantation -Longitudinal study on entry and exit from sterile room and long-term prognosis-
Acronym Multicenter collaborative research on psychiatric symptoms of hematopoietic cell transplantation -Longitudinal study on entry and exit from sterile room and long-term prognosis-
Scientific Title Observation study of psychiatric symptoms in patients admitted to sterile rooms with hematopoietic cell transplantation
Scientific Title:Acronym Observation study (Longitudinal study)
Region
Japan

Condition
Condition hematological cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the factors that predict psychiatric symptoms during and after entering and leaving the sterile room of patients undergoing hematopoietic stem cell transplantation.
Basic objectives2 Others
Basic objectives -Others To clarify the factors that associated with psychiatric symptoms during and after entering and leaving the sterile room of patients undergoing hematopoietic stem cell transplantation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CESD (The Center for Epidemiology Studies Depression scale) was performed before entering the sterile room, during entering the room, at the time of leaving the room, and 3, 6 and 12 months after leaving the room.
Key secondary outcomes - POMS2 (Profile of Mood States 2nd Edition) was performed before entering the sterile room, during entering the room, at the time of leaving the room, and 3, 6 and 12 months after leaving the room.
- Before entering the sterile room, SCID (Structured Clinical Interview for DSM-4 AXIS I Disorders), INTERMED, and MAC (Mental Adjustment to Cancer) were performed.
- GHQ30 (The General Health Questionnaire) was performed 3, 6 and 12 months after leaving the room.
- MMSE (Mini Mental State Examination) was performed before entering the sterile room and 12 months after leaving the room.

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 (1) Patients over 20 years old
(2) Patients who have received sufficient explanation in participating in this research and obtained written consent at their own free will.
(3) Patients planning the first hematopoietic stem cell transplant for hematopoietic cancer (less than 5 points in Hematopoietic Cell Transplantation-Comorbidity Index)
Key exclusion criteria (1) Patients with consciousness disturbance or severe dementia
(2) Patients who have difficulty in evaluating by questionnaire or interview because their physical symptoms are severe.
(3) Patients with speech / hearing or visual impairment that affect understanding of the method in the evaluation
(4) Patients with psychiatric disorders other than depression, such as schizophrenia
(5) Others who are judged to be inappropriate by the principal investigator or the co-investigator
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Yamamoto
Organization Tokai University
Division name School of Medicine, Department of Psychiatry
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL +81463931121
Email key@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Yamamoto
Organization Tokai University
Division name School of Medicine, Department of Psychiatry
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
TEL +81463931121
Homepage URL
Email key@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kurashiki Central Hospital

Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
Tel +81463931121
Email tokai-rinsho@ml.tokai-u.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2546
Org. issuing International ID_1 Kurashiki Central Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東海大学医学部付属病院、倉敷中央病院

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 15 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 70
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Data analysis is delayed.
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 Completed
Date of protocol fixation
2017 Year 05 Month 15 Day
Date of IRB
2017 Year 05 Month 15 Day
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Several scales made it possible to predict depression measured by CES-D when leaving the sterile room.

Management information
Registered date
2022 Year 05 Month 02 Day
Last modified on
2022 Year 05 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054244

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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