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

NCT ID: NCT07038174

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-12-31

Brief Summary

[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).

Conditions

Infertility, Female; Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

Received only the planned cancer treatment without any additional intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Fertility preservation decision aid intervention group

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 40803737 (View on PubMed)

Other Identifiers

NCC2024-0050

Identifier Type: -

Identifier Source: org_study_id