UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050777 |
|---|---|
| Receipt number | R000057836 |
| Scientific Title | Appetite and subjective symptoms in patients after hematopoietic stem cell transplantation: Cross-sectional study |
| Date of disclosure of the study information | 2023/04/17 |
| Last modified on | 2024/04/05 12:35:02 |
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Basic information
Public title
Appetite and subjective symptoms in patients after hematopoietic stem cell transplantation: Cross-sectional study
Acronym
Appetite and subjective symptoms in patients after hematopoietic stem cell transplantation: Cross-sectional study
Scientific Title
Appetite and subjective symptoms in patients after hematopoietic stem cell transplantation: Cross-sectional study
Scientific Title:Acronym
Appetite and subjective symptoms in patients after hematopoietic stem cell transplantation:Cross-sectional study
Region
| Japan |
Condition
Condition
Hematopoietic tumor
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the severity of appetite and subjective symptoms in outpatients after hematopoietic stem cell transplantation.
Basic objectives2
Others
Basic objectives -Others
To determine the characteristics associated with appetite in outpatients after hematopoietic stem cell transplantation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appetite
Key secondary outcomes
subjective symptoms, nutritional data
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who diagnosed hematopoietic tumor and after autologous and allogeneic hematopoietic stem cell transplantation
2.Outpatients who have been discharged from hospital for at least one month
3.18 years of age or older
Key exclusion criteria
1.Patients who have severe mental illness
2.Patients who have been diagnosed with relapse
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Yagasaki |
Organization
Keio University
Division name
Faculty of nursing and medical care
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-2157
yagasaki@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Inoue |
Organization
Keio University Graduate School
Division name
Graduate School of Health Management, Nursing
Zip code
252-0816
Address
4411 Endo, Fujisawa-shi, Kanagawa
TEL
0466-49-6200
Homepage URL
h22702mi@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 17 | 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
55
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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational cross-sectional study
Management information
Registered date
| 2023 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057836
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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