UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044976 |
|---|---|
| Receipt number | R000051389 |
| Scientific Title | Long-term course of physical function in children with cancer who received rehabilitation during inpatient treatment |
| Date of disclosure of the study information | 2021/07/28 |
| Last modified on | 2021/07/28 09:21:16 |
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Basic information
Public title
Long-term course of physical function in children with cancer who received rehabilitation during inpatient treatment
Acronym
Long-term course of physical function in children with cancer
Scientific Title
Long-term course of physical function in children with cancer who received rehabilitation during inpatient treatment
Scientific Title:Acronym
Long-term course of physical function in children with cancer
Region
| Japan |
Condition
Condition
childhood cencer
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the long-term course of physical function and quality of life in children with cancer who underwent rehabilitation during inpatient treatment
Basic objectives2
Others
Basic objectives -Others
the long-term course
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Days to return to school after discharge
Key secondary outcomes
Grip strength; Knee extension strength; One leg stand test; Timed Up and Go test; Six-minute walk test; New physical fitness test of Japanese MEXT; Functional independence measure/functional assessment measure; Pediatric quality of life inventory; body composition; physical activity
Time point of measurement:
a. Inpatient treatment period
First time, every treatment, at the time of discharge
b. Post-discharge observation period
3 months, 6 months, 12 months, 36 months after discharge
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with cancer
Cancer therapy and hospitalization
Key exclusion criteria
Severe developmental disorder
Communication disorder
Astasia-abasia
Severe exercise-induced asthma
The terminal phase of the disease
No cooperation in inspection and measurement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tobita |
Organization
Shiga University of Medical Science Hospital
Division name
Rehabilitation Units
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2670
tobirin@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tobita |
Organization
Shiga University of Medical Science Hospital
Division name
Rehabilitation Units
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2670
Homepage URL
tobirin@belle.shiga-med.ac.jp
Sponsor or person
Institute
Rehabilitation Units, Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Rehabilitation Units, Shiga University of Medical Science Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pediatrics, Shiga University of Medical Science Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rehabilitation Units, Shiga University of Medical Science Hospital
Address
Seta Tsukinowa-cho, Otsu, Shiga
Tel
077-548-2670
tobirin@belle.shiga-me.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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 07 | Month | 06 | Day |
Other
Other related information
<Standard medical care>
a. After hospitalization / diagnosis, a request is made with the consent of the pediatrician regarding the introduction of rehabilitation.
At the same time, explanations and consent for this research will be obtained.
b. The rehabilitation doctor who received the request will prescribe the rehabilitation and the therapist in charge will be decided.
c. Initial rehabilitation evaluation is performed at the stage when treatment for the disease is started.
d. During the treatment period, rehabilitation evaluation is performed for each treatment phase.
e. When the treatment is completed, a rehabilitation evaluation will be conducted at the time of discharge.
<Observation by this study>
f. After discharge, rehabilitation evaluation will be performed regularly at the time of outpatient visit (3 months, 6 months, 12 months, 36 months, up to 3 years).
Management information
Registered date
| 2021 | Year | 07 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051389
