UMIN-CTR Clinical Trial

Public title

A study examining the effectiveness of cancer education targeting young adults

Acronym

CEYA Study

Scientific Title

Evaluating the Effectiveness and Sustainability of Cancer Education Interventions for Young Adults: A Pilot Randomized Controlled Trial

Scientific Title:Acronym

CEYA Trial

Region

Japan

Condition

cancer

Classification by specialty

Nursing

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Cancer is a common disease affecting one in two Japanese individuals during their lifetime, making it a critical health issue for multiple generations, including young adults. However, cancer education for young adults after high school graduation is not systematically established. It has been pointed out that insufficient knowledge and low literacy may contribute to the formation of negative perceptions and prejudices (cancer stigma), such as equating cancer with death. Previous studies have shown that short educational interventions can improve cancer knowledge and attitudes among young people. Our preliminary research also demonstrated that a single lecture session led to improved knowledge and literacy, as well as a reduction in sub-factors of stigma.
This study (pilot test) aims to verify the feasibility of the research procedures prior to the planned randomized controlled trial (RCT) designed to evaluate the effectiveness of educational interventions in improving cancer knowledge and literacy and reducing stigma. Specifically, it will obtain foundational data necessary for calculating an appropriate sample size (e.g., effect size, standard deviation, follow-up response rate) and conduct a scaled-down randomized controlled trial (RCT) using the same intervention method, evaluation items, and measurement timing as the main trial. This will clarify the validity of the intervention procedures, the understandability of the questionnaires, and operational challenges in the data collection process. Furthermore, changes in knowledge, cancer literacy, and stigma will serve as primary indicators to explore the direction and approximate magnitude of the educational intervention's effects. Findings will inform adjustments to the study design and sample size calculations for the main survey.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The primary outcome is the change in the Japanese Cancer Stigma Scale (J-CASS) score following the educational intervention. The same scale will be administered at three time points: baseline (pre-intervention: T0), immediately after the intervention (T1), and one month after the intervention (T2). The reduction in the stigma score at T1 will be the primary endpoint for comparison.

Key secondary outcomes

Cancer stigma
Cancer stigma will be assessed at T0, T1, and T2, and changes in scores from T0 to T2 will be compared to evaluate the sustainability of the intervention effect.

Cancer-related knowledge
Cancer-related knowledge will be assessed using the Japanese Cancer Intelligence Quotient Knowledge domain (JCIQ-K) at T0, T1, and T2. Changes in scores at T1 and T2 will be examined.

Cancer literacy
Cancer literacy will be assessed using the Japanese Cancer Intelligence Quotient Literacy domain (JCIQ-L) at T0, T1, and T2, and changes in scores over time will be evaluated.

Health literacy
Health literacy will be assessed using the eHealth Literacy Scale (eHEALS) and the European Health Literacy Survey Questionnaire short form (HLS-EU-Q12) at T0 and T2, and changes in scores will be examined.

Loneliness
Loneliness will be assessed using the Japanese version of the UCLA Loneliness Scale (Version 3), short form, at T0 and T2, and changes in scores will be explored.

Social support
Perceived social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS) at T0 and T2, and changes in scores will be examined.

Feasibility outcomes
Feasibility will be assessed based on response and follow-up rates, missing data, questionnaire completion time, comprehensibility of survey items, and estimates of effect sizes and standard deviations to inform the design of a future full-scale trial.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Other

Interventions/Control_1

Intervention participants will receive a single session of a lecture-based cancer education program. The lecture content will be developed based on cancer education materials produced by the Ministry of Education, Culture, Sports, Science and Technology in Japan and will consist of two main domains: (1) basic knowledge of cancer, including cancer development, prevention, screening, and an overview of treatment, and (2) the experiences and psychosocial aspects of cancer patients and their families. The lecture will be delivered in a face-to-face format using slide-based materials and will last approximately 40 minutes. No additional materials will be distributed, and no supplementary or follow-up learning activities will be provided.
Participants will complete a web-based baseline survey immediately prior to the intervention (T0). On the intervention day, participants will attend the lecture, and a post-intervention survey (T1) will be conducted within three days after the lecture. Educational effects at T1 will be assessed using measures of cancer knowledge (Japanese Cancer Intelligence Quotient, Knowledge domain: JCIQ-K), cancer literacy (Japanese Cancer Intelligence Quotient, Literacy domain: JCIQ-L), and cancer stigma (Japanese Cancer Stigma Scale: J-CASS). To examine the maintenance and change of educational effects, an additional online follow-up survey will be conducted one month after the intervention (T2). The lecture will be delivered only once, and no other educational interventions will be implemented during the study period.
During the study period, participants will not be restricted from accessing general cancer-related information. Information seeking through books, the internet, and social networking services will be permitted. However, the lecture content and educational materials used as part of the research intervention will be managed to ensure that they are not shared with the control group during the study period.

Interventions/Control_2

The control group will be assigned to a no-lecture condition and will not receive any specific educational intervention at the time of the intervention, maintaining their usual student life. Participants in the control group will complete the baseline survey at T0 during the same period as the intervention group. No educational procedures will be implemented for the control group during the time when the intervention group attends the lecture, and participants' activities will be limited to their routine academic and daily learning behaviors.
Outcome assessments will be conducted at the same time points as in the intervention group. The T1 survey will be administered during the same period as the post-lecture assessment for the intervention group. Identical evaluation measures will be used in both groups to allow for direct between-group comparisons. A follow-up survey will also be conducted one month later (T2) to assess natural changes in cancer knowledge, cancer literacy, and cancer stigma over time in the absence of an educational intervention.
As an ethical consideration, after completion of all study assessments in this pilot study (after T2), the control group will be provided with educational materials equivalent to those used in the intervention group, in order to ensure fairness in access to educational opportunities. These materials will be delivered in a format such as a lecture or video and will be provided at a time point that does not affect the research data.
During the study period, participants will not be restricted from accessing general cancer-related information through books, the internet, or social networking services. However, the lecture content and educational materials used as part of the research intervention will be managed to ensure that they are not shared with the control group during the study period.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

36

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Be a student aged 18 or older at the time of consent acquisition
(2) Have no history of cancer
(3) Be able to read and write in Japanese
(4) Have received sufficient explanation regarding participation in this study, fully understand it, and have consented of their own free will

Key exclusion criteria

(1) Individuals who are deemed unable to participate in the educational intervention or complete the questionnaires due to mental or physical reasons
(2) Individuals aged 36 or older (the upper age limit for participation is 35)
(3) Individuals who are judged unsuitable as research participants by the principal investigator

Target sample size

30

Name of lead principal investigator

1st name	Kinoshita
Middle name
Last name	Yumiko

Organization

University of Miyazaki

Division name

Department of Integrated Clinical Nursing Science, School of Nursing, Faculty of Medicine

Zip code

880-1692

Address

5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture, Japan

TEL

0985-85-9826

Email

yumiko_kinoshita@med.miyazaki-u.ac.jp

Name of contact person

1st name	Kinoshita
Middle name
Last name	Yumiko

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 Prefecture, Japan

TEL

0985-85-9826

Homepage URL

Email

yumiko_kinoshita@med.miyazaki-u.ac.jp

Institute

University of Miyazaki

Institute

Department

Personal name

Yumiko Kinoshita

Organization

The Yasuda Memorial Medical Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Committee of the Faculty of Medicine, University of Miyazaki

Address

5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture, Japan

Tel

0985-85-9403

Email

rinken@med.miyazaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

01

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

12

Month

05

Day

Date of IRB

Anticipated trial start date

2026

Year

01

Month

05

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

12

Month

01

Day

Last modified on

2026

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068525