Tokyo, Jan. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059931) titled 'A study examining the effectiveness of cancer education targeting young adults' on Jan. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - University of Miyazaki

Condition: Condition - cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - The intervention group will receive a single lecture-based cancer education program. The lecture content, based on cancer education materials developed by the Ministry of Education, Culture, Sports, Science and Technology (MEXT), will cover two areas: (1) basic knowledge about cancer such as cancer development, prevention, screening, and treatment, and (2) feelings and psychosocial aspects experienced by cancer patients and their families. The lecture will be conducted face-to-face using slide materials and will last approximately 40 minutes. No additional materials will be distributed, and no supplementary learning will be provided. Participants will attend the lecture on the intervention day, with baseline assessment conducted immediately before the intervention (T0) and immediate post-intervention assessment conducted immediately after the lecture (T1). The T1 assessment will evaluate educational effectiveness using the Japanese Cancer Intelligence Quotient Knowledge domain (JCIQK), Japanese Cancer Intelligence Quotient Literacy domain (JCIQL), and Japanese Cancer Stigma Scale (JCASS). An online survey will also be conducted one month after the intervention (T2) to confirm the maintenance and changes in educational effectiveness. The lecture will be conducted only once, and no other educational interventions will be provided during the intervention period. Interventions/Control_2 - The control group will receive no special educational intervention at the time of the intervention and will maintain their normal student life as the no-lecture group. Participants in the control group will undergo baseline surveys at T0, similar to the intervention group. No educational measures will be implemented for the control group during the period when the intervention group attends the lecture, and they will continue their daily learning activities. At T1 (immediately after the lecture), the same assessment scales will be administered to the control group to standardize the timing for intergroup comparisons. A follow-up survey will also be conducted at T2 (one month later) to assess changes in knowledge, literacy, and stigma due to natural progression. As an ethical consideration, after all surveys for this pilot study are completed (post T2), equivalent educational materials (lecture or video) to those used in the intervention group will be provided to the control group to ensure fairness in educational opportunities. This will be done at a time that does not affect the research data.

Eligibility: Age-lower limit - 18 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 Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 05 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068525

Disclaimer: Curated by HT Syndication.