UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056666 |
|---|---|
| Receipt number | R000064622 |
| Scientific Title | A Qualitative Study of Psychosocial Support for Patients and Families After Hematopoietic Stem Cell Transplantation Visiting Multiple Outpatient Clinics |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/08 17:15:40 |
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Basic information
Public title
A Qualitative Study of Psychosocial Support for Patients and Families After Hematopoietic Stem Cell Transplantation Visiting Multiple Outpatient Clinics
Acronym
A Study of Psychosocial Support for Patients and Families After Hematopoietic Stem Cell Transplantation
Scientific Title
A Qualitative Study of Psychosocial Support for Patients and Families After Hematopoietic Stem Cell Transplantation Visiting Multiple Outpatient Clinics
Scientific Title:Acronym
A Study of Psychosocial Support for Patients and Families After Hematopoietic Stem Cell Transplantation
Region
| Japan |
Condition
Condition
Patients who received auto/allo hematopoietic stem cell transplant
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the situations, contents, and needs of psychological and social support for patients and families who received hematopoietic stem cell transplantation during childhood.
Basic objectives2
Others
Basic objectives -Others
To identify the support that their patients and family members need.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Situations, contents and needs of psychological and social support for patients and family members
Key secondary outcomes
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients (12 years of age or older) who received auto/allo hematopoietic stem cell transplant and their family members who have been in remission for at least one year
Key exclusion criteria
Unsuitability for participation due to the participant's physical or mental health, as determined by pediatricians
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Nakajima |
Organization
Teikyo University
Division name
Department of Nursing, Faculty of Medical Technology
Zip code
173-8605
Address
2-11-1 Kaga, Itabashi, Tokyo
TEL
+81-3-3964-1211
shoheinf@gmail.com
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Nakajima |
Organization
The University of Tokyo Hospital
Division name
Nursing Department
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo, Tokyo
TEL
+81-3-3964-1211
Homepage URL
shoheinf@gmail.com
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Tokyo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, the Faculty of Medicine and Graduate School of Medicine of the University of Tokyo and the University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo, Tokyo
Tel
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional survey combined with semi-structured interviews and medical records.
Management information
Registered date
| 2025 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064622
