A Study to Evaluate the Effectiveness of a Web-based Tool for Fertility Preservation in Cancer Patients

Официальное название

A Study for Development and Testing of Fertility Preservation Decision Aid for Young Cancer Patients

Обзор

\[Background\] 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. \[Study Plan\] 1. Study Design * Randomized clinical study * Prospective study * Two-arm randomized controlled trial (RCT) 2\. 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).

Вмешательства

• Другое Fertility preservation decision aid intervention group
  Visited the website containing the web-based decision aid regarding fertility preservation at least once before cancer treatment initiation to independently use the tool in a private setting

Первичные конечные точки

• Decisional conflict score [Срок оценки: Before the intervention, one week after the intervention, and one month after the intervention.]

Вторичные конечные точки (7)

• Knowledge about fertility preservation [Срок оценки: Before the intervention, one week after the intervention, and one month after the intervention.]
• Depression severity [Срок оценки: Before the intervention, one week after the intervention, and one month after the intervention.]
• Health-Related Quality of Life [Срок оценки: Before the intervention, one week after the intervention, and one month after the intervention.]
• Decision-Making Confidence [Срок оценки: Before the intervention, one week after the intervention, and one month after the intervention.]
• Counselling on fertility preservation [Срок оценки: one month after the intervention]
• Decision-making about fertility preservation [Срок оценки: one month after the intervention]
• Readiness for decision-making [Срок оценки: one week after the intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Jang J, Lee EM, Chung YK, Lee DO, Park HJ, Yim GW, Lee KS, Kim JH, Ko AR, Hong JH, Kang S. Development and pilot testing of a personalised decision aid for decision-making regarding fertility preservation in young female patients with cancer: a study protocol. BMJ Open. 2025 Aug 12;15(8):e090759. doi: 10.1136/bmjopen-2024-090759. PMID 40803737

Идентификаторы

NCT: NCT07038174 · NCC2024-0050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗