UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047644
Receipt number 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 19:43:29

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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 or person

Institute

Tokai University

Institute

Department

Personal name



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

Value
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