UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046287 |
|---|---|
| Receipt number | R000052825 |
| Scientific Title | Verification of the effectiveness of breast cancer educational intervention for healthy people |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/12/06 09:36:07 |
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Basic information
Public title
Verification of the effectiveness of breast cancer education for healthy people
Acronym
Verification of the effectiveness of breast cancer education
Scientific Title
Verification of the effectiveness of breast cancer educational intervention for healthy people
Scientific Title:Acronym
Verification of effectiveness of breast cancer education
Region
| Japan |
Condition
Condition
healthy people
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of educational effect
Basic objectives2
Others
Basic objectives -Others
Verification of educational effect
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination behavior(Before and after intervention, 3 months later)
Key secondary outcomes
Level of understanding
Level of satisfaction
Interest in family history
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy person with no history of breast cancer
Key exclusion criteria
Those who do not speak Japanese as their mother tongue
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Kohbata |
Organization
Tokyo Medical and Dental University
Division name
Bioethics Research Center
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
0358034085
kohbbec@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Kohbata |
Organization
Tokyo Medical and Dental Univ.
Division name
Bioethics Research Center
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
0358034085
Homepage URL
kohbbec@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental Univ.
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of TMDU
Address
1-5-45 Yushima, Bunkyo, Tokyo
Tel
0358035096
syomu1.adm@tmd.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
| 2022 | Year | 10 | Month | 01 | 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
| 2022 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052825
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
