UMIN-CTR Clinical Trial

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