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 | 2026/05/11 17:33:07 |
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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
cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine changes in cancer-related knowledge and cancer literacy following a cancer education intervention among young adults, as well as changes in self-efficacy related to information utilization and cancer-related behaviors, including information seeking and communication. Furthermore, the study aims to longitudinally investigate the relationships between these cognitive and behavioral changes and the formation and modification of cancer stigma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in total and subscale scores of the Japanese Cancer Stigma Scale (J-CASS) from baseline (T0) to 3 months after the intervention (T3)
Key secondary outcomes
Changes 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), electronic health literacy measured by the eHealth Literacy Scale (eHEALS), cancer-related active engagement, self-efficacy for health behaviors, loneliness measured by the short-form UCLA Loneliness Scale, and perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS) from baseline (T0) to each follow-up time point (T1, T2, T3, and T4) will be evaluated.
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 45-minute face-to-face cancer education program. The educational content includes the current status of cancer in Japan, cancer prevention, cancer treatment, and living with cancer, using PowerPoint materials, video materials, and cancer survivor narratives. The intervention also includes individual reflective activities designed to encourage participants to relate the content to themselves.
Interventions/Control_2
Participants in the control group will continue their usual daily life until completion of the T3 assessment (3 months after the intervention). Access to cancer-related information during the study period will not be restricted. After completion of the T3 assessment, educational opportunities equivalent to those provided to the intervention group (face-to-face education or video-based educational materials) will be offered.
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 provided informed consent voluntarily 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 aged under 18 years or over 35 years
(3)Individuals judged by the principal investigator to be inappropriate for participation in the study for other reasons
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | 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 | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070402
