UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047697 |
|---|---|
| Receipt number | R000054378 |
| Scientific Title | Retrospective Study of Inpatients with Childhood Leukemia to Prepare for Rehabilitative Medical Care System That Supports Physical Activity. |
| Date of disclosure of the study information | 2022/07/19 |
| Last modified on | 2023/11/10 10:11:39 |
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Basic information
Public title
Retrospective Study of Inpatients with Childhood Leukemia to Prepare for Rehabilitative Medical Care System That Supports Physical Activity.
Acronym
Retrospective Study of Inpatients with Childhood Leukemia to Prepare for Rehabilitative Medical Care System That Supports Physical Activity.
Scientific Title
Retrospective Study of Inpatients with Childhood Leukemia to Prepare for Rehabilitative Medical Care System That Supports Physical Activity.
Scientific Title:Acronym
Retrospective Study of Inpatients with Childhood Leukemia to Prepare for Rehabilitative Medical Care System That Supports Physical Activity.
Region
| Japan |
Condition
Condition
Childhood Leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Rehabilitation medicine |
| Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Survey of the age of pediatric leukemia patients and rehabilitation content / evaluation indicators
Basic objectives2
Others
Basic objectives -Others
Survey of the rate of rehabilitation for pediatric leukemia patients and the reasons for discontinuation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rehabilitation content / evaluation index for each age
Key secondary outcomes
Rehabilitation implementation rate (including analysis of training location) and reason for discontinuation
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A case in which leukemia was diagnosed while in the pediatrics department of our hospital during the 9 years from April 2012 to March 2020, and a medical treatment request was made to the rehabilitation department.
Key exclusion criteria
Cases without a rehabilitation prescription. Cases in which missing values are included in the evaluation items.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Saotome |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
1628655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
0332027181
isaotome@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
1628655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
0332027181
Homepage URL
kkikuchi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1, toyama, shinjuku-ku, Tokyo
Tel
0332027181
rinriji@hosp.ncgm.go.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
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 19 | 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
50
Results
Data collection/analysis in progress
Results date posted
| 2022 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
pediatric leukemia patients
Participant flow
Search past medical records
Adverse events
None
Outcome measures
Age, training content, and evaluation index of pediatric leukemia patients
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective Observational Study
Management information
Registered date
| 2022 | Year | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054378
