NCT07038174

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

Not yet recruiting NA Last updated 26 June 2025

What this trial tests

NA trial testing Fertility preservation decision aid intervention group in Infertility, Female in 32 participants. Not yet recruiting.

Timeline

30 June 2025

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	National Cancer Center, Korea
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	32
Start date	30 June 2025
Primary completion	31 December 2025
Estimated completion	31 December 2025

Drugs / interventions tested

• Fertility preservation decision aid intervention group

Conditions studied

• Infertility, Female — all drugs for Infertility, Female →
• Neoplasms — all drugs for Neoplasms →

Sponsor

National Cancer Center, Korea

Who can join

Adults 18 to 40, female only, with Infertility, Female or Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

\[Background\] 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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and pilot testing of a personalised decision aid for decision-making regarding fertility preservation in young female patients with cancer: a study protocol.
   Jang J, Lee EM, Chung YK, Lee DO, et al · · 2025 · cited 1× · PMID 40803737 · DOI 10.1136/bmjopen-2024-090759