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
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
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
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
