UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057976 |
|---|---|
| Receipt number | R000066281 |
| Scientific Title | Communication About the Disclosure of Hereditary Cancer to Children: A Scoping Review Protocol |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/09/09 14:18:12 |
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Basic information
Public title
Communication About the Disclosure of Hereditary Cancer to Children: A Scoping Review Protocol
Acronym
Communication About the Disclosure of Hereditary Cancer to Children: A Scoping Review Protocol
Scientific Title
Communication About the Disclosure of Hereditary Cancer to Children: A Scoping Review Protocol
Scientific Title:Acronym
Communication About the Disclosure of Hereditary Cancer to Children: A Scoping Review Protocol
Region
| Japan |
Condition
Condition
Hereditary Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to comprehensively review the current state of communication regarding the disclosure of hereditary tumors between parents and children, and to provide insights that will serve as a guide for future research on supportive approaches.
Basic objectives2
Others
Basic objectives -Others
This review aims to address the following research questions:
To clarify when and how parents and healthcare professionals disclose hereditary tumor information to children.
To organize how communication regarding disclosure to children is supported, including the types of interventions available.
To determine whether these support (intervention) methods have been validated and evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The current status of communication in disclosure and its support, and the effectiveness of that support.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria
1)Studies related to communication and support regarding the disclosure of hereditary tumors to children will be included.
2)No restrictions will be placed on study design.
3)Studies written in English or languages that the authors can accurately review will be included.
4)Relevant literature will be manually searched, and all non-duplicated studies meeting the criteria will be included in this scoping review.
Key exclusion criteria
1)Studies for which only the title and abstract are available, and the full text cannot be accessed, will be excluded.
2)Studies including data from participants aged 18 years or older will be excluded if 20% or more of the participants are 18 years old or above.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kaito |
| Middle name | |
| Last name | Sugima |
Organization
Niigata University
Division name
Graduate School of Health Sciences
Zip code
951-8518
Address
746 Asahimachi-dori 2-ban-cho, Chuo-ku, Niigata City, Niigata Prefecture.
TEL
0252272263
b24a302b@mail.cc.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaito |
| Middle name | |
| Last name | Sugima |
Organization
Niigata University
Division name
Department of Nursing, School of Health Sciences Faculty of Medicine.
Zip code
9518518
Address
746 Asahimachi-dori 2-ban-cho, Chuo-ku, Niigata City, Niigata Prefecture.
TEL
0252272364
Homepage URL
b24a302b@mail.cc.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Sugima Kaito
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saint Lukes International University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata City ,Japan
Tel
025-227-2625
ethics@adm.niigata-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
English
Management information
Registered date
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066281
