A Study for Development and Testing of Fertility Preservation Decision Aid for Young Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Decisional conflict score
研究概览
简要总结
[Background] The number of young cancer patients is increasing, and they may experience impairment or loss of reproductive function due to cancer treatments such as surgery, radiation therapy, and chemotherapy.
Although various medical methods to preserve fertility have been developed, due to the complexity and medical specialization of these methods, there is an urgent need to support understanding and decision-making regarding these options in clinical practice.
While referrals to fertility specialists for counseling are possible, most young cancer patients do not receive such consultations before treatment. Even those who do often report decisional conflict due to confusion about the information and difficulty in reflecting personal values in the decision-making process.
Although decision aids have been developed in other countries, cultural, linguistic, and healthcare system differences make it difficult to apply these tools in Korea.
Therefore, there is a need to develop a decision aid tailored to female cancer patients in Korea for use in local clinical settings to support fertility preservation decisions.
[Study Objective] To develop a web-based decision aid and evaluate its impact on decisional conflict, fertility preservation-related knowledge, decision self-efficacy, depression, and quality of life, in order to assess the effectiveness of the decision aid.
[Study Hypothesis]
The use of a web-based decision aid for fertility preservation will:
Reduce decisional conflict experienced by cancer patients during the decision-making process; Improve fertility preservation-related knowledge and decision self-efficacy; Reduce levels of depression and improve quality of life.
[Study Plan]
- Study Design
- Randomized clinical study
- Prospective study
- Two-arm randomized controlled trial (RCT)
- Study Method Female cancer patients visiting the outpatient clinic of the National Cancer Center will be screened to determine eligibility based on inclusion and exclusion criteria.
Patients who meet the criteria and voluntarily agree to participate will be enrolled in the study.
Participants will be randomly assigned to either the intervention group (who will use the decision aid) or the control group (who will receive standard cancer treatment as planned at the Cancer Center without any special tools).
The decision aid will be provided to the intervention group immediately after randomization. The control group will not receive any additional tools.
Outcomes will be measured at three time points for the intervention group: before the intervention (T0), one week after the intervention (T1), and one month after the intervention (T2).
For the control group, measurements will be taken at the same time points: immediately after randomization (T0), one week later (T1), and one month later (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female cancer patients aged 18 to 40 who received treatment at the National Cancer Center between June 2025 and December 2025
- •Voluntarily agreed to participate in the study
- •Able to read, write, and communicate in Korean without difficulty
排除标准
- •Patients who had already lost fertility prior to participating in the study
- •Patients who had already undergone, or were scheduled to undergo, a specific fertility preservation procedure
结局指标
主要结局
Decisional conflict score
时间窗: Before the intervention, one week after the intervention, and one month after the intervention.
Name of the measurement: Decisional conflict score assessed by the Decisional Conflict Scale (DCS) Measurement tool: The Decisional Conflict Scale (DCS) - low literacy version Measure description: The level of decisional conflict experienced by participants regarding a health-related decision will be assessed using the Decisional Conflict Scale (DCS) - low literacy version, a validated 10-item questionnaire. Each item is rated on yes(0), unsure(2), no(4), and scores are converted to a 0-100 scale, with higher scores indicating greater decisional conflict. The unit of measure will be the mean total score on the DCS at the specified timepoint. Subscale scores (e.g., uncertainty, informed, values clarity, support, and effective decision) may also be calculated. Unit of measure: Mean scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
次要结局
- Knowledge about fertility preservation(Before the intervention, one week after the intervention, and one month after the intervention.)
- Depression severity(Before the intervention, one week after the intervention, and one month after the intervention.)
- Health-Related Quality of Life(Before the intervention, one week after the intervention, and one month after the intervention.)
- Decision-Making Confidence(Before the intervention, one week after the intervention, and one month after the intervention.)
- Counselling on fertility preservation(one month after the intervention)
- Decision-making about fertility preservation(one month after the intervention)
- Readiness for decision-making(one week after the intervention)