Development and pilot testing of a personalised decision aid for decision-making regarding fertility preservation in young female patients with cancer: a study protocol

Abstract

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration

NCT07038174 (beta-testing phase).

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• The intervention group will use the web-based fertility preservation decision aid (DA) independently, which will make this study well-suited to assess the effectiveness of the DA in a setting where patients with cancer autonomously use the fertility preservation DA.

• This study evaluates the effectiveness of the fertility preservation DA after independent use by patients with cancer outside the clinical setting, which limits its ability to assess the effectiveness of the DA in shared decision-making between patients and medical professionals within clinical settings.

Introduction

With advances in cancer treatment, the survival of patients with cancer has continuously improved over the past decades.^{1 2} However, the gains from cancer treatment have come with costs, including therapy-related secondary cancer occurrence, psychosocial problems, onset of musculoskeletal diseases and infertility.³,⁵ Among the adverse outcomes that occur after cancer treatments, infertility is one of the major complications found in young patients with cancer and has been shown to have a substantial negative effect on the quality of life of cancer survivors.⁶,⁸ With these issues regarding infertility in patients with cancer, many societies and groups, including the American Society of Clinical Oncology and the European Society of Human Reproductive and Embryology, have released guidelines for fertility preservation (FP) in patients with cancer.^{9 10} Although these guidelines recommend discussion and/or referral before cancer treatment starts, <50% of patients with cancer receive counselling regarding the risk of infertility before treatment,¹¹ and only 67% of oncologists refer to patients for consults with a fertility specialist or reproductive endocrinologist.¹²

This low percentage of counselling and/or referrals is mainly derived from barriers, including the lack of knowledge about FP options, disagreement between surgical oncologists and medical oncologists, lack of available written FP information and time pressure and lack of infrastructure for multidisciplinary discussion and/or referral at professional and organisation levels.¹²,¹⁴ In a situation such as this, it is very difficult for patients with cancer to be well-informed and make decisions about FP options independently in a short time before cancer treatment. Moreover, FP is not an essential medical treatment for patients with cancer, and personalised values and preferences have a substantial influence on decision-making. Therefore, it is necessary to construct an environment that helps patients with cancer recognise the risk of infertility before the start of cancer therapies and make decisions about FP quickly, considering each patient’s clinical situation and personal values and preferences.

To date, several educational materials and decision aids (DAs) for FP decision-making have been developed,¹⁵,²⁰ and some of these were also introduced in web-based formats across various countries.¹⁶,²⁰ Among them, some DAs go beyond simply providing one-way information and incorporate a process of value clarification where information about the patient’s values is gathered and used to facilitate decision-making.^{16 17} DAs that incorporate this interactive value clarification process have the advantage of helping users make FP decisions that reflect the values they deem important. However, some of the existing DAs developed in an interactive form are limited in that they target specific user groups, such as parents of children and adolescents with cancer.¹⁷

Even when value clarification is included, the outcomes provided to the DA users only offer simplified information about the level of agreement with selecting a specific FP option¹⁶ or the priority of undergoing FP. As a result, it is difficult to intuitively assess how well each FP option aligns with the patient’s important values, or which FP option is most suitable when considering these values. Therefore, it is necessary to create an environment that helps patients with cancer recognise the risk of infertility and understand FP options that are most suitable for their clinical situation and align with their values and preferences.

Therefore, we aim to 1) develop a personalised DA that can assist patients with cancer in making decisions about FP by considering each patient’s situation (deciding whether or not to receive FP treatment, which FP options to choose when they decide to receive FP treatment or to withhold their decision on FP), 2) conduct an alpha test to assess the acceptability and usability of the developed DA and 3) perform a field test (beta test) to assess the effectiveness of the DA in improving decision quality and related outcomes.

Methods

Scope and setting

This protocol was designed to develop a DA that satisfies the 47 criteria of the International Patient Decision Aid Standards (IPDASi).²¹ It was approved by the International Review Board (IRB) at the National Cancer Centre, Korea (IRB No. NCC2024-0050). The clinical trial protocol (Trial registration no. NCT07038174) is available at the following site: https://clinicaltrials.gov. The intended users of this DA are women of reproductive age (18–40 years) who have been diagnosed with cancer. It is designed for use throughout the entire continuum of cancer treatment including before, during and after treatment. This DA encompasses information on all FP options that each patient can choose in Korea within legal boundaries, presenting alternatives such as choosing not to undergo FP. The decision about whether or not to undergo FP treatment and, if so, which FP option a patient will opt for is the index decision of this DA. The primary objective of this protocol is to develop a DA that facilitates shared decision-making about FP for young female patients with cancer who are at risk of infertility. In particular, we aim to assist in shared decision-making between oncologists or reproductive endocrinologists and patients in clinical settings and effectively incorporate patient values and preferences into the decision-making process. For these goals, this study will be conducted in three stages: 1) development of the FP-DA draft, 2) alpha testing to evaluate the acceptability and usability of the FP-DA, and 3) beta testing to assess the feasibility of the FP-DA.

Recruitment for alpha testing to evaluate usability and acceptability was completed on 30 April 2025, and participants for beta testing to assess the effectiveness of the FP-DA will be recruited from 30 June to 31 December 2025.

To perform these processes, a steering committee and an expert panel, each consisting of 13 experts, are formed. The steering committee members make plans and directional decisions on this project and consist of two gynaecologic oncologists, two surgical oncologists, three medical oncologists, one paediatric oncologist, one public health expert, one clinical psychologist, one social worker and two counselling nurses. The steering committee reviews the DA development protocol to ensure that the DA is developed in accordance with the criteria of the IPDASi. Additionally, the committee reviews the alpha- and beta-testing study design and checks whether the DA is updated to satisfy the feedback from the DA users. Independent of the steering committee, a board for the expert panel is established. Thirteen reproductive specialists from different institutions compose the expert panel. These specialists are endorsed by two or more fellow reproductive specialists and have experience with various FP procedures and counselling of patients with cancer. The expert panel defines customised options for various patient situations and confirms the validity of the information provided for each option. Four of the steering committee members (SK, YKJ, JJ and EML) act as working group members and are in charge of the development of the web-based FP-DA and setting and conducting alpha and beta testing.

Development of the decision aid

The FP-DA will be developed in a web-based form and structured into three modules: 1) an information collection module, which is employed to gather the necessary information from the patients to select suitable FP options for them; 2) an option suggestion module that presents available FP options in the patient’s situation and provides the necessary information for decision-making for each option; and 3) a value communication module that elicits and clarifies a patient’s individual values and preferences regarding FP and incorporates these into providing the optimal choices (figure 1).

Figure 1. Flow diagram of the development and alpha and beta-testing of the web-based fertility preservation decision aid. DA, decision aid; FP, fertility preservation.

Development of the decision aid: information collection module

First, to develop the information collection module, we will review the literature to explore patient characteristics that need to be considered when determining applicable FP options. Then, we will conduct a survey of fertility-preserving specialists to determine whether these characteristics are required for counselling and selecting an FP option for patients with cancer. They will be asked to respond on a binary scale (yes or no) to a close-ended questionnaire asking whether they think a specific item is essential for recommending and selecting optimal FP options for patients with cancer. The necessity of each item to determine suitable FP options will then be assessed through a selection process based on the item-level content validity index (I-CVI). Items with an I-CVI of ≤0.8 will be chosen, and users (patients with cancer) will be asked to provide their information about these items when they use the web-based FP-DA.

Development of the decision aid: option suggestion module

Second, to develop an option suggestion module, a logical framework for selecting applicable FP options according to a patient’s condition will be developed by expert committee members. The expert panel will determine FP options available for each combination of the patient’s selected items in the information collection module. Notably, alternatives not legally available in the current Korean society will not be included in this consideration, and in the case of any controversy regarding this matter, legal experts will be consulted.

In this option suggestion module, DA users will be provided with essential information to make a decision about FP. To determine what information should be provided to patients with cancer and healthcare providers, three approaches, including 1) narrative interviews, 2) online surveys of young patients with cancer and 3) an online survey of reproductive endocrinologists, will be conducted.

The participants in the narrative interview are women aged 18–40 who were diagnosed with cancer and who received counselling about FP at the National Cancer Centre, Korea, between January 2020 and June 2023. Identified patients will be approached via telephone, and interviews will be conducted only with those who consent, either in person or over the phone. The interview guide will be developed by the steering committee, and the interviewees will be asked what information is required and what personal values are important when they make decisions about FP. The audio-recorded interview results will be electronically transcribed and subsequently reviewed by the researchers. From these transcribed interviews, two researchers (JJ and EML) will determine the domains of information needs and the corresponding items within each domain. In addition to the domains and items of information need obtained through narrative interviews, additional domains and items will be added through a literature review of previously announced FP-DAs.

Then, a survey with reproductive endocrinologists will be conducted to determine what information is required and important when they provide counselling about FP for patients with cancer. For information items created through narrative interviews and literature reviews, respondents will be asked to respond on a 5-point Likert scale about the degree to which each item is required and important. Then, items with an I-CVI >0.8 (proportion of respondents who responded with 4–5 points ≥0.8) are considered to provide substantial information during FP counselling by reproductive endocrinologists.

The determination of domains will be subjected to deliberation within the steering committee for finalisation. Then, an online survey will be conducted to assess the importance of each item included in the finalised domains for the general female population aged 18–40 years. The respondents will be asked to respond on a 5-point Likert scale on how necessary they think each piece of information is in the decision-making process for FP. The aggregated items and importance rankings set by patients will be provided to expert panels, who will ultimately decide which items to provide information on, starting with the highest-ranked ones.

For established items, a draft literature review will be prepared based on the information provided by two reproductive endocrinologists (YKJ and DOL) and one public health expert (JJ). The drafted document will undergo two rounds of the Delphi consensus process targeting an expert panel to reach a final consensus. In summary, this module, based on the input information of previously obtained patients, provides all available fertility-sparing options and can display individualised options to choose from. The steering committee will decide to review and determine whether the benefits and harms of selectable options are provided at an equivalent level. Options tailored for each patient are presented in a tabular format for easy comparison.

Development of the decision aid: value communication module

The third module aims to clarify the personal values of patients and suggest FP options that reflect these values. To achieve this, the personal value items will be selected as follows. Through the narrative interviews of young patients with cancer introduced above and the literature review, a list of personal values that affect decision-making about the FP will be drawn up. Then, the steering committee will deliberate to select the values, and those values will be confirmed through a survey of the general female population by checking that the proportion of respondents who agree that each value is important for making a decision about FP is >0.8.

After the determination of personal values, the working group members will create a matrix draft that evaluates how well each FP option satisfies the determined personal values. The columns of the matrix represent the FP options, and the rows represent the level to which each option satisfies each personal value. The satisfaction level of each option with a specific personal value is indicated using a 3-point Likert scale. The matrix draft will be reviewed by five reproductive endocrinology experts and finalised after revisions. DA users will input their preferences regarding personal values during use, allowing them to self-assess which values they prioritise. Then, they can check the matrix to see how well each FP option satisfies their values, helping them determine the most suitable FP option based on the importance of their values.

After the development of the three modules above, the working group members will prepare the product requirements documents (PRD) to illustrate the format, design and function of the web-based FP-DA. The three modules mentioned above will be implemented as separate pages on the web, and users can freely navigate between pages using the navigation bar and access the functions. The PRD will be delivered to the outsourcing company to develop a website. The website will be developed using responsive design to adjust the presentation for desktops, tablets and mobile phones. Additionally, the users can download the result file (PDF) at the last webpage, which includes information on the personal values that each user considers important and their final decision about FP after using the FP-DA. After the website prototype development is complete, the working group members and expert panels will review the prototype and make minor revisions for improvement.

Alpha testing of the decision aid

Acceptability and usability test of the developed DA will be conducted with a small test group. The test group will consist of young patients with cancer aged 18–40 years who visit the National Cancer Centre before starting any cancer treatment (n=10) and healthcare providers (n=5) who agree to participate. Participants will be provided with the opportunity to access the DA through a personal computer or tablet using a URL. After the self-use of the DA, the participants will be asked to complete an online survey to assess the acceptability and usability of the DA. The measures to evaluate acceptability and usability will be developed as follows. First, researchers will review the literature regarding the pilot testing of FP-DAs. Then, all domains and items used to evaluate the acceptability and usability of the DAs will be listed through the data saturation method. The final domains and items will be determined by the steering committee through a two-round Delphi process.

Together with a survey using predeveloped tools, qualitative research will be conducted to assess the acceptability and usability of the FP-DA by using an open-ended question asking about any additional requirements or unsatisfactory parts during FP-DA usage. Based on the results from the acceptability and usability tests and qualitative research, the FP-DA draft will be revised for improvement before beta testing by the steering committee.

Beta testing of the decision aid

The beta test will take the form of a pilot randomised, parallel-group trial with a 1:1 allocation ratio, conducted after the FP-DA has been revised based on user feedback from alpha testing. Participants will be recruited from among patients with cancer who are diagnosed and have plans to receive cancer treatment at the National Cancer Centre, Korea, and the four regional cancer centres along with hospitals that offer FP treatments in Korea. The inclusion criteria are as follows: patients who are 1) 18–40 years old, 2) histologically diagnosed with cancer and before receiving any curative treatment and 3) can provide informed consent. Since the DA developed is designed for independent use by patients with cancer, we planned to recruit only patients who are literate and can use the DA independently. Therefore, patients who cannot understand the DA because of a language barrier or visual impairment will be excluded. However, the DA we developed can still be effectively used in a clinical setting with the help of family members or healthcare professionals, even if the patient is unable to use it independently. In practice, this allows patients who may not be literate to still access the DA. Additionally, patients who are already receiving curative treatment or undergoing an FP procedure will be excluded. Patients who meet the eligibility criteria will be screened in each centre or hospital that participates in this beta test and will be approached either in person or via telephone. Participants who voluntarily signed informed consent will be randomly assigned to either the DA group (intervention group) or the usual care group (control group), and blinding will not be applied.

The random allocation sequence will be generated using a computer-generated simple randomisation method. No stratification or other restrictions (such as blocking) will be applied. Allocation will be implemented via telephone call, which reveals the group assignment only after participant enrollment is confirmed. Both the researchers responsible for participant enrolment and those assigning interventions will have no access to the random allocation sequence before assignment. The intervention group is provided with the opportunity to access the web-based DA and receives education on how to use the online aid. The intervention group will then use the tool independently in a self-directed setting. The control group, designated the usual care group, will not have access to the web-based DA; however, the decision to consult an FP specialist will be made at the discretion of the attending physician and the patient. Participants will be informed that they may withdraw from the study at any stage of participation on their request, without any consequences.

The sample size for beta testing was calculated based on an alpha error of 0.05, power of 80%, effect size (Cohen’s d) of 0.85 and a dropout rate of 10%. A total of 32 participants (16 in each group: intervention and control) will be randomised in this study. For the effect size, a previous study evaluating the effectiveness of online DAs related to FP was referenced.¹⁶ The estimated effect size is based on the mean difference of decisional conflict scores between the intervention and control groups and the SD from this study. Although the effect size was 0.9 in the previous study, the effect size was adjusted to 0.85 for the present study to test for a slightly smaller effect.

Decisional conflict using a decisional conflict scale developed by O’Connor et al will be set as the primary outcome measure to assess the effectiveness of the FP-DA²² (table 1). Decisional conflict is widely recognised as one of the most commonly used indicators for evaluating the effectiveness of DAs.²³ Additionally, no single best FP decision can be applied to all patients; rather, the most appropriate decision depends on each patient’s situation and personal values. Therefore, the selection of a specific FP option will not be suitable as an outcome measure. What matters more is how confident the patient feels in their choice and how much confusion they experienced during the decision-making process. Thus, decisional conflict is set as the primary outcome. The decisional conflict scale will be used after the translation of questions in English into Korean, as the decisional conflict scale measure is not provided in Korean. Together with the total decisional conflict score, subscores on the uncertainty subscale, informed subscale, value clarity subscale and support subscale will be used to assess decisional conflict.

Table 1. Measurements at each time point in the beta-testing.

Measurement	Objective	Intervention group			Control group
		T0	T1	T2	T0	T1	T2
Participant characteristics: age, education, monthly household income, marital status, pregnancy, parity, region, cancer type, cancer stage, planned cancer treatment, health literacy	Baseline characteristics	O			O
Reproductive Concerns Scale	Baseline characteristics	O			O
Decisional conflict Scale	Primary outcome	O	O	O	O	O	O
Knowledge	Secondary outcome	O	O	O	O	O	O
Decision self-efficacy scale	Secondary outcome	O	O	O	O	O	O
Preparation for the decision-making scale	Secondary outcome		O
PHQ-9 (severity of depression)	Secondary outcome	O	O	O	O	O	O
EQ-5D-5L (quality of life)	Secondary outcome	O	O	O	O	O	O
Counselling on fertility preservation	Exploratory outcome			O			O
Decision-making about fertility preservation	Exploratory outcome			O			O

EQ-5D-5L, EuroQol five-dimension, five-level questionnaire; PHQ-9, Patient Health Questionnaire-9.

Knowledge about FP will be assessed as a secondary outcome measure. To select knowledge items about FP, we will review guidelines and previous studies regarding the development and assessment of FP-DA and then select the information items that are emphasised to be provided to patients with cancer and the frequently asked about knowledge items. A set of experts will be approached and asked to determine whether to include each item for knowledge assessment. Through a two-round Delphi process, knowledge items about FP will be determined. After the determination of knowledge items, researchers will prepare questions, and the developed questions and responses will be finally revised according to the review of the expert panel members. Additionally, self-confidence in one’s abilities in decision making will be measured as a secondary outcome by using the Decision Self-efficacy Scale tool. The readiness for decision-making, which will be evaluated using the Preparation for Decision-Making Scale developed by O’Connor et al, will also be measured. In addition to knowledge, the degree of depression severity assessed using the Patient Health Questionnaire-9 (PHQ-9) and health-related quality of life evaluated using the EuroQol 5-dimension 5-level (EQ-5D-5L) will also be used as secondary outcomes. As an exploratory outcome, we will measure whether patients actually receive medical counselling related to FP and whether they actually undergo FP surgery.

The assessment of the outcome measures will be conducted at three time points: just before the intervention (T0), within 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. For the decisional conflict scale, knowledge, decision self-efficacy, depression severity and quality of life will be measured three times, before and after the intervention (T0, T1 and T2), for both the intervention and control groups. The counselling and decision-making about FP will be measured once at T2 for both the intervention and control groups.

All study data will be entered electronically using a web-based platform. Data entry will be performed directly by participants (self-administered surveys). To ensure data accuracy and integrity, automated range checks, logic validation rules and mandatory field settings will be implemented within the system.

Based on the information obtained through the data collection module in the FP-DA, descriptive statistics on the characteristics of patients with cancer will be analysed. Based on the hypothesis that using the FP-DA will improve the quality of decision-making, we predict that decisional conflict will decrease and knowledge about FP will increase between the FP-DA user group and the usual cancer group and between before and after the use of the FP-DA. For decisional conflict, a score >37.5 is defined as a high decisional conflict associated with decision delay and feeling unsure about the decision.²⁴ Changes in the proportions of patients with cancer who experience high decisional conflict before and after FP-DA usage will be evaluated using McNemar’s test. For knowledge about FP, we will calculate the percentage of women who know the correct answers for each knowledge item before using the FP-DA to discover areas in which female patients with cancer lack FP-related knowledge. The improvement in the quality of decision-making due to DA use will be evaluated by assessing the change in the percentage of correct answers of each knowledge item before and after using the DA based on McNemar’s test. The overall knowledge level about FP will be assessed by a 5-point Likert scale for each item and summarised. The average scores of the knowledge and decision self-efficacy before and after the use of the DA will be compared using paired t-tests.

In addition to comparisons of outcomes at before and after intervention testing, differences in decisional conflict, knowledge, decision self-efficacy, degree of depression severity (PHQ-9) and quality of life (EQ-5D-5L) between the FP-DA user group and the usual care group will also be assessed through univariable analysis (χ2 test or Student’s t test) at each outcome measurement point.

Patient and public involvement

Patients or the public will not be involved in the design, conduct, reporting or dissemination plans of this research. Likewise, patients with cancer participating in this study will not be involved in the design, implementation and distribution of the research. However, if participants want to know the results of the research, they will receive the publicly distributed materials, including publications or academic presentations on this study.

Ethics and dissemination

This study protocol was reviewed and approved by the Institutional Review Board (IRB) of the National Cancer Centre, Korea (IRB No. NCC2024-0050). The eligible individuals will be informed about the objective, plans and processes of this study and the dissemination of findings from this study before they make a decision to participate. Individuals who wish to participate in this study will be asked to provide informed consent before enrolment, which will be obtained by the research staff conducting the enrolment. They will be aware of their rights: to be free to withdraw from the study at any time, access their results and contact them when they have questions, concerns and suggestions about the research.

De-identification will be achieved by allocating a unique ID to each participant, and any identifiable participant information will be securely stored and kept confidential. Access to the data collected from the participants will be limited to the principal investigator and research coordinator, who will be appointed before the research begins. The collected information will be stored for at least 5 years after research completion. All of the information obtained from this research will be destroyed immediately after the termination of the data storage period. A Data Safety Monitoring Board is not required for this study because the risk to the subject is minimal.

The data generated from this research will be presented at conferences or scientific meetings and submitted to peer-reviewed journals for publication. Additionally, findings of this study will be distributed to the general population as well as study participants by displaying the results on the website and in media releases.

Individual participant data will not be shared due to concerns about participant privacy and the potential risk of re-identification, especially given the sensitive nature of the data. In addition, no current resources or infrastructure are in place to support secure data sharing.

Any important modifications to the study protocol—such as changes to eligibility criteria, outcomes, study procedures or analysis plans—will be promptly communicated to all relevant parties. These include the IRB, trial registry, participating investigators, research team members and, where applicable, study participants.

DISCUSSION

In young patients with cancer, fertility loss due to cancer treatment is a major cause of decreased quality of life, and the importance of FP to prevent this has emerged.⁸ Nevertheless, it is difficult for patients with cancer to make decisions about FP at an appropriate time due to many barriers in the clinical environment and numerous factors that must be considered in decision-making about FP.^{13 14}

Despite the difficulties that patients with cancer face in making decisions related to FP as mentioned above, educational materials to help patients are rarely provided, and a few DAs have been developed; however, there are limitations in their application in clinical fields.¹⁶,²⁰²⁵ Existing DAs are limited in that they either provide information in a one-way manner or even if developed interactively to reflect patients’ value information, the information generated from collecting values has often been limited to fragmented levels, such as the level of agreement with a specific FP option or the priority of undergoing FP in the current situation. Therefore, we develop a DA that suggests applicable FP options considering the patient’s clinical situation and provides specific information on how well each FP option satisfies the patient’s personal values and preferences. Additionally, we develop a DA that can be used independently by young patients with cancer and help them make decisions regarding FP, and we expect that the developed FP-DA will be widely used in clinical settings in the future.

The FP-DA that we are planning has as its core value helping patients with cancer receive suggestions of FP options by taking into account the patient’s personal characteristics, values and preferences. We believe that the data generated from the DA development will help in identifying FP-related unmet needs in patients with cancer. To date, the unmet needs and barriers related to FP have been investigated through several studies, and these studies have shown a difference in the barriers perceived by healthcare providers and patients with cancer in counselling and decision-making about FP for young patients with cancer.³² Therefore, we aimed to understand the situation and areas in which patients with cancer, as well as healthcare providers, are unsatisfied with FP counselling or decision-making. Additionally, this study is expected to provide evidence on how much the quality of decision-making can be improved after applying an FP-DA to patients with cancer. Specifically, given that the intervention group evaluates the effectiveness of the FP-DA after patients with cancer independently use it in an autonomous environment, this study setting allows for assessing whether the DA can improve FP decision-making even when used independently. However, owing to this study setting, a limitation arises in that it does not permit the direct evaluation of whether the developed DA is effective and helpful in the shared decision-making process between patients with cancer and medical professionals in actual clinical settings. Although we cannot directly assess the effectiveness of the FP-DA on shared decision-making in clinical settings in this study, we expect that the FP-DA developed here holds potential to help health professionals conduct FP-related counselling in patients with cancer more effectively in clinical environments with numerous barriers.

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.