UMIN-CTR Clinical Trial

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
Email	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
Email	tobirin@belle.shiga-med.ac.jp

Sponsor
Institute	Rehabilitation Units, Shiga University of Medical Science Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051389