UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056701 |
|---|---|
| Receipt number | R000064817 |
| Scientific Title | Questionnaire survey on the use of "How to have a better school life (trial version)," a tool to support school life for childhood cancer patients |
| Date of disclosure of the study information | 2025/01/13 |
| Last modified on | 2025/01/13 21:36:12 |
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Basic information
Public title
Questionnaire survey on the use of "How to have a better school life (trial version)," a tool to support school life for childhood cancer patients
Acronym
Questionnaire survey on the use of "How to have a better school life (trial version)," a tool to support school life for childhood cancer patients
Scientific Title
Questionnaire survey on the use of "How to have a better school life (trial version)," a tool to support school life for childhood cancer patients
Scientific Title:Acronym
QSLSTCCS
Region
| Japan |
Condition
Condition
childhood cancer
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Various physical and psychosocial changes due to the onset and treatment of childhood cancer can cause difficulties in returning to school. The Education Working Group of the Long-term Follow-up Committee of the Japan Children's Cancer Group (JCCG) has developed a trial version of a school life support tool, How to Have a Better School Life, to share the physical and psychosocial considerations necessary for school life after pediatric cancer treatment with children, families, school teachers and medical personnel after returning to school, and hospital classroom teachers in a bidirectional manner. The tool was created as a trial version of How to live a better school life. The purpose of this project is to identify problems with this tool and to improve it by conducting a questionnaire survey on how to use the tool after completing and using the How to have a better school life (trial version), a tool to support school life for childhood cancer patients.
Basic objectives2
Others
Basic objectives -Others
Tool adequacy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tool Usage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
An intervention in which childhood cancer patients return to school after pediatric cancer treatment to complete and use the How to Have a Better School Experience (trial version) school life support tool.
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
| 10 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Childhood cancer patients who have developed childhood cancer and have returned to elementary, junior high, high school, or special-needs school after inpatient treatment at a JCCG-registered facility participating in this study as a collaborating institution.
Key exclusion criteria
Childhood cancer patients who do not wish to receive support for returning to school using school life support tools
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hideko |
| Middle name | |
| Last name | Uryu |
Organization
National Center for Global Health and Medicine
Division name
Department of Pediatrics
Zip code
1628655
Address
1-21-1 Toyama Shinjuku-ku Tokyo
TEL
0332027181
huryuu@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Hideko |
| Middle name | |
| Last name | Uryu |
Organization
National Center for Global Health and Medicine
Division name
Department of Pediatrics
Zip code
1628655
Address
1-21-1 Toyama Shinjuku-ku Tokyo
TEL
0332027181
Homepage URL
huryuu@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Hideko Uryu
Funding Source
Organization
Children's Cancer Association of Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
rinrijm@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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064817
