UMIN-CTR Clinical Trial

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
Email	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
Email	kohbbec@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental Univ.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052825