Jang Jieun, Lee Eun Mi, Chung Youn Kyung, Lee Dong Ock, Park Hyeon Jin, Yim Ga Won, Lee Keun Seok, Kim June Hyuk, Ko A Ra, Hong Ji Hee, Kang Sokbom
Division of Clinical Research, Research Institute, National Cancer Center, Goyang, Republic of Korea.
Center for Gynecologic Cancer, National Cancer Center, Goyang, Republic of Korea.
BMJ Open. 2025 Aug 12;15(8):e090759. doi: 10.1136/bmjopen-2024-090759.
Infertility resulting from cancer treatment is known to be a major factor that reduces the quality of life of young cancer survivors. However, discussions and decision-making about fertility preservation before cancer treatment have been insufficient owing to barriers in the clinical field. In addition, selecting a fertility preservation option requires a complex decision-making process that considers not only medical information but also the patient's values and preferences. Hence, an environment that more easily supports patient decision-making about fertility preservation needs to be created. Therefore, this protocol will develop and test a web-based decision aid (DA) for fertility preservation among young patients with cancer, considering patient preferences and values, evaluate acceptability and usability of the developed DA and assess its effectiveness.
This protocol outlines the development of a web-based DA for fertility preservation targeting females of reproductive age diagnosed with cancer. It includes alpha testing to evaluate the usability and acceptability of the DA, as well as beta testing to assess its effectiveness outside of clinical settings, both based on an online survey. The web-based DA for fertility preservation consists of three modules: 1) an information collection module, 2) an option suggestion module and 3) a value communication module. The information collection module collects information essential to select appropriate fertility preservation options. The option suggestion module returns all applicable fertility preservation options based on the patient's characteristics, which are essential for determining the appropriate option, such as menarche status and desire for pregnancy. The value communication module provides information on the extent to which each fertility preservation option satisfies the patient's values and preferences. After the development of the DA, a small group of young patients with cancer (n=10) and health providers (n=5) will be asked to use this web-based DA for fertility preservation and assess the acceptability and usability of this DA based on a survey (alpha-testing). By reflecting the feedback of acceptability and usability testing, the DA will be updated for improvement, and clinical field testing (beta-testing pilot trial) will be performed using the updated DA. Beta-testing will be conducted on young patients with cancer (aged 18-40 years) before they receive any curative cancer treatment (n=32). These patients with cancer will be randomly allocated to the DA group (intervention group) or the usual care group (control group). The DA group will use the web-based DA before treatment, and the control group will not have access to the web-based DA and will be asked to decide whether to consult a fertility preservation specialist. The primary outcome of the beta testing will be the level of decisional conflict, and the secondary outcomes will include knowledge, decision self-efficacy, decision readiness, depression severity, quality of life, counselling on fertility preservation and decision-making about fertility preservation. Outcomes, including decisional conflict, knowledge, decision self-efficacy, quality of life and depression severity, will be measured before the intervention (T0), 1 week after the intervention (T1) and 1 month after the intervention (T2). The readiness for decision-making will be assessed at T1 for the intervention group only. Counselling on fertility preservation and decision-making about fertility preservation will be assessed once after testing (T2) for both the intervention and control groups.
The study will be conducted in accordance with ethical standards and was approved by the Institutional Review Board at the National Cancer Centre, Korea (IRB No. NCC2024-0050). All study participants will provide written informed consent before participation. The results generated from this study will be presented at conferences or scientific meetings and disseminated through publication in a peer-reviewed journal.
NCT07038174 (beta-testing phase).
癌症治疗导致的不孕是降低年轻癌症幸存者生活质量的一个主要因素。然而，由于临床领域存在障碍，关于癌症治疗前生育力保存的讨论和决策一直不够充分。此外，选择生育力保存方案需要一个复杂的决策过程，不仅要考虑医学信息，还要考虑患者的价值观和偏好。因此，需要创造一个更易于支持患者进行生育力保存决策的环境。因此，本方案将开发并测试一种针对年轻癌症患者的基于网络的决策辅助工具（DA），考虑患者的偏好和价值观，评估所开发的DA的可接受性和可用性，并评估其有效性。
本方案概述了一种针对被诊断患有癌症的育龄女性的基于网络的生育力保存DA的开发。它包括用于评估DA的可用性和可接受性的alpha测试，以及基于在线调查在临床环境之外评估其有效性的beta测试。基于网络的生育力保存DA由三个模块组成：1）信息收集模块，2）方案建议模块和3）价值沟通模块。信息收集模块收集选择合适的生育力保存方案所需的基本信息。方案建议模块根据患者的特征返回所有适用的生育力保存方案，这些特征对于确定合适的方案至关重要，如月经初潮状态和怀孕意愿。价值沟通模块提供关于每种生育力保存方案满足患者价值观和偏好程度的信息。在开发DA之后，将邀请一小群年轻癌症患者（n = 10）和医疗服务提供者（n = 5）使用这种基于网络的生育力保存DA，并根据一项调查评估该DA的可接受性和可用性（alpha测试）。通过反映可接受性和可用性测试的反馈，对DA进行更新以改进，并使用更新后的DA进行临床现场测试（beta测试试点试验）。将在年轻癌症患者（18至40岁）接受任何根治性癌症治疗之前（n = 32）进行beta测试。这些癌症患者将被随机分配到DA组（干预组）或常规护理组（对照组）。DA组将在治疗前使用基于网络的DA，对照组将无法使用基于网络的DA，并将被要求决定是否咨询生育力保存专家。beta测试的主要结果将是决策冲突水平，次要结果将包括知识、决策自我效能感、决策准备度、抑郁严重程度、生活质量、生育力保存咨询和生育力保存决策。包括决策冲突、知识、决策自我效能感、生活质量和抑郁严重程度在内的结果将在干预前（T0）、干预后1周（T1）和干预后1个月（T2）进行测量。仅对干预组在T1评估决策准备度。干预组和对照组在测试后（T2）均将对生育力保存咨询和生育力保存决策进行一次评估。
本研究将按照伦理标准进行，并获得了韩国国立癌症中心机构审查委员会的批准（IRB编号：NCC2024 - 0050）。所有研究参与者在参与前将提供书面知情同意书。本研究产生的结果将在会议或科学会议上展示，并通过在同行评审期刊上发表进行传播。
NCT07038174（beta测试阶段）。
