UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061523 |
|---|---|
| Receipt number | R000070402 |
| Scientific Title | Effectiveness of a Cancer Education Intervention on Cancer Stigma, Knowledge, and Literacy Among Young Adults: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/06/18 16:36:05 |
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Basic information
Public title
Study on Changes in Knowledge and Attitudes Through Cancer Education Among Young Adults
Acronym
CEYA Study
Scientific Title
Effectiveness of a Cancer Education Intervention on Cancer Stigma, Knowledge, and Literacy Among Young Adults: A Randomized Controlled Trial
Scientific Title:Acronym
CEYA-RCT
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to examine the effect of a cancer education intervention on cancer stigma among young adults. In addition, the study aims to evaluate its impact on cancer-related knowledge, cancer literacy, information-seeking behaviors, health behaviors, and behavioral intentions. Furthermore, the study will longitudinally investigate the relationships between cognitive and behavioral changes resulting from the intervention and changes in cancer stigma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline (T0) to 3 months after intervention (T3) in the six subscale scores of the Japanese Cancer Stigma Scale (J-CASS): Severity, Personal Responsibility, Awkwardness, Opposition to Policy, Financial Discrimination, and Avoidance.
Key secondary outcomes
Changes from baseline (T0) to each follow-up time point (T1, T2, T3, and T4) in cancer-related knowledge measured by the Japanese Cancer Intelligence Quotient for Knowledge (JCIQ-K), cancer literacy measured by the Japanese Cancer Intelligence Quotient for Literacy (JCIQ-L), cancer-related active engagement (including cancer information-seeking behavior, electronic health literacy measured by the eHealth Literacy Scale [eHEALS], communication about cancer, contact experiences with cancer survivors, health behaviors, and behavioral intentions), loneliness measured by the short-form UCLA Loneliness Scale, and perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Participants in the intervention group will receive a face-to-face cancer education program lasting approximately 45 minutes. The educational materials are adapted from the Ministry of Education, Culture, Sports, Science and Technology (MEXT) cancer education resources and cover four themes: the current status of cancer in Japan, cancer prevention, cancer treatment, and living with cancer. The program includes PowerPoint-based lectures, video materials, cancer survivor narratives, and reflective activities designed to encourage participants to relate the content to their own lives. Standardized materials and a scripted narration will be used to ensure consistency of the intervention. The intervention will be delivered by the principal investigator.
Interventions/Control_2
Participants in the control group will continue their usual daily lives until completion of the 3-month follow-up assessment (T3). Access to cancer-related information will not be restricted during the study period. After completion of the T3 assessment, participants will be provided with educational materials and video content equivalent to those used in the intervention group.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Students aged 18 to 35 years at the time of consent
(2) Individuals without a history of cancer
(3) Individuals able to complete questionnaires in Japanese
(4) Individuals who voluntarily provided written informed consent after receiving a full explanation of the study
Key exclusion criteria
(1) Individuals judged to have difficulty participating in the educational intervention or completing questionnaires due to mental or physical conditions
(2) Individuals judged by the principal investigator to be inappropriate for participation in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Kinoshita |
Organization
University of Miyazaki
Division name
Department of Integrated Clinical Nursing Science, School of Nursing, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, Japan
TEL
0985-85-9826
yumiko_kinoshita@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Kinoshita |
Organization
University of Miyazaki
Division name
Department of Integrated Clinical Nursing Science, School of Nursing, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, Japan
TEL
0985-85-9826
Homepage URL
yumiko_kinoshita@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Yumiko Kinoshita
Funding Source
Organization
Public Interest Incorporated Foundation Yasuda Memorial Medical Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, University of Miyazaki
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, Japan
Tel
0985-85-9403
rinken@med.miyazaki-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 | 05 | Month | 11 | 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
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | 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 | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070402
