UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062687 |
|---|---|
| Receipt number | R000071477 |
| Scientific Title | Development and Feasibility of a Breast Awareness Education Program in Preconception Care: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/25 20:27:02 |
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Basic information
Public title
Development and Feasibility of a Breast Awareness Education Program in Preconception Care: A Pilot Randomized Controlled Trial
Acronym
Development and Feasibility of a Breast Awareness Education Program in Preconception Care: A Pilot Randomized Controlled Trial
Scientific Title
Development and Feasibility of a Breast Awareness Education Program in Preconception Care: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Development and Feasibility of a Breast Awareness Education Program in Preconception Care: A Pilot Randomized Controlled Trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a breast awareness education program for preconception care, conduct a pilot randomized controlled trial, and evaluate the feasibility of future randomized controlled trials.
Basic objectives2
Others
Basic objectives -Others
To exploratively assess the estimated effect sizes of this intervention on information, motivation, behavioral skills, and health-related outcomes, and to obtain foundational data for determining sample size and evaluating the validity of outcome measures in future randomized controlled trials.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility of the educational program
Key secondary outcomes
1.Health behaviors related to breast health
2.Knowledge of preconception care
3.Knowledge of breast awareness
4.Japanese version of the eHealth Literacy Scale (eHEALS)
5.Motivation for preconception care
6.Motivation to improve breast awareness
7.Health Interest Scale
8.Behavioral skills for improving breast awareness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will participate in a proposed breast awareness education program as part of preconception care. The program consists of lectures, group work, and practical exercises.
Interventions/Control_2
No intervention will be provided to the control group. An educational program will be offered to participants who wish to enroll after the study concludes.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Individuals who have given their personal consent to participate.
2. Female undergraduate and graduate students who were between the ages of 18 and 30 on the date consent was obtained.
Key exclusion criteria
1. Individuals who have taken Course B at University A during the 2025 and 2026 academic years.
2. Individuals who cannot understand or read Japanese.
3. Students enrolled in medical undergraduate or graduate programs.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Mansai |
Organization
Kagoshima University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima
TEL
099-275-6792
mnsai-tr@health.nop.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Mansai |
Organization
Kagoshima University
Division name
School of Health Sciences, Faculty of Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima
TEL
099-275-6792
Homepage URL
mnsai-tr@health.nop.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
St.Luke's international university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima
Tel
099-275-6240
crmc@m2.kufm.kagoshima-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
| 2026 | Year | 08 | Month | 25 | 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
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071477
