UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054862 |
|---|---|
| Receipt number | R000062188 |
| Scientific Title | Examining Effective Support in Two Transitions Experience by Childhood Cancer Survivors.Single arm intervention test. |
| Date of disclosure of the study information | 2024/07/03 |
| Last modified on | 2026/01/12 20:28:55 |
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Basic information
Public title
Examining Effective Support in Two Transitions Experience by Childhood Cancer Survivors
- From pediatric cancer treatment to late complications treatment, from pediatric to adult medicine -
Acronym
Examining Effective Support in Two Transitions Experience by Childhood Cancer Survivors.Single arm intervention test.
Scientific Title
Examining Effective Support in Two Transitions Experience by Childhood Cancer Survivors.Single arm intervention test.
Scientific Title:Acronym
Examining Effective Support in Two Transitions Experience by Childhood Cancer Survivors.Single arm intervention test.
Region
| Japan |
Condition
Condition
Pediatric Oncology
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine effective support in two transitions experienced by childhood cancer survivors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of TRANSISION-Q
Before and after educational support for two transitions experienced by childhood cancer survivors.
Key secondary outcomes
General Self-Efficacy Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
Educational Interventions Related to Childhood Cancer Disease Management
(1)Late complication education based on study participants' treatment history
(2)Education to relate study participants' late complications to the adult department to which they are transitioning.
(3)Two visits to the Adult Health Care Transitional Support Outpatient Clinic.
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Childhood cancer survivors receiving pediatric long-term follow-up outpatient visits in the pediatric oncology department at the study site.
2.Those who are between 12 years old (junior high school student) and 18 years old at the time of obtaining consent.
3.Japanese as the primary language and capable of giving informed consent or assent.
4.Those for which consent has been obtained from the individual and his/her parent or guardian.
5.The applicant must be able to respond to web or self-administered questionnaires in Japanese.
6.Those who have never been seen in the transitional support outpatient clinic at the research facility in the past.
Key exclusion criteria
Their physician has determined that their medical condition and mental status make it difficult for them to participate in the study.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Kiyoko |
| Middle name | |
| Last name | Kamibeppu |
Organization
International University of Health and Welfare
Division name
Graduate School of public Health Department of Family Nursing
Zip code
107-8402
Address
4-1-26 Akasaka, Minato City, Tokyo
TEL
03-5574-3900
kkamibeppu@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Iwasaki |
Organization
International University of Health and Welfare
Division name
Graduate School of public Health Department of Family Nursing
Zip code
107-8402
Address
4-1-26 Akasaka, Minato City, Tokyo
TEL
03-5574-3900
Homepage URL
22s3056@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Certified NPO Heartlink Working Project
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The University of Tokyo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Tokyo Akasaka Ethics Review Board
Address
Akasaka, Minato City, Tokyo 107-8402
Tel
03-5574-3900
rinri-tky@iuhw.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
東京大学医学部附属病院（東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 03 | 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
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062188
