UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028975 |
|---|---|
| Receipt number | R000033086 |
| Scientific Title | A longitudinal study of quality of life in hematopoietic stem cell transplant recipients |
| Date of disclosure of the study information | 2017/09/02 |
| Last modified on | 2023/09/14 16:56:42 |
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Basic information
Public title
A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Acronym
A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Scientific Title
A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Scientific Title:Acronym
A longitudinal study of quality of life in hematopoietic stem cell transplant recipients
Region
| Japan |
Condition
Condition
Hematological disorders
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The longitudinal evaluation of QOL and the identification of factors affecting QOL in hematopoietic stem cell transplant recipients
Basic objectives2
Others
Basic objectives -Others
QOL
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL changes over time after hematopoietic stem cell transplantation
Key secondary outcomes
Factors affecting QOL after hematopoietic stem cell transplantation
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. Adult hematological patients who underwent hematopoietic stem cell transplantation at Toranomon Hospital
2. Patients who can answer the QOL questionnaire written in Japanese
3. Patients from whom written informed consent has been obtained
Key exclusion criteria
Patients who are deemed ineligible by the treating physician
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Asano-Mori |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
105-8470
Address
2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
TEL
03-3588-1111
yuki-am@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Asano-Mori |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
105-8470
Address
2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
TEL
03-3588-1111
Homepage URL
yuki-am@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Family Nursing, Division of Health Science and Nursing, Graduate School of Medicine, The University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Trial and Research
Address
2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
| 2017 | Year | 09 | Month | 02 | 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
551
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data is currently being analyzed
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center longitudinal study, to analyze QOL changes over time and factors associated with QOL after hematopoietic stem cell transplantation
Management information
Registered date
| 2017 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033086
