NCT06894810

Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors

A Double Blind Randomised Controlled Trial of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The current standard of care for paediatric patients with cancer regarding preservation of their fertility (FP) is to provide high-quality information during the clinical consultation process. However, this approach depends on health provider knowledge and communication and has been shown to be sub-optimal in some situations. This impairs the critical decision-making of patients regarding fertility testing, utilization of gametes, and continuing payment of storage fees. The fertility preservation decision aid (FP DA) may lead to a greater understanding of their fertility status for participants. This knowledge may allow participants the opportunity to assess potential fertility issues prior to the end of their reproductive window, helping to minimize missed opportunities for parenthood. This research study aims to assess the effectiveness of the use of the FP DA on unmet fertility information needs when it is provided in addition to high-quality information in parents of cancer survivors and CAYA cancer survivors compared to high-quality information alone.

Detailed description

Medical advances over recent decades have increased the overall survival rates of children, adolescents and young adults diagnosed with cancer, with survival rates now exceeding 80%. The pressure points are not only at diagnosis - research has shown that cancer treatment can potentially affect fertility later in life. Survivorship is an important time for addressing the following issues: fertility status, reproductive monitoring, decisions about interval fertility preservation, ongoing tissue storage and utilization. Options to preserve fertility are possible. Decision Aids (DA) have been developed to provide patients and their families with the required information to make informed reproductive health decisions that align with their values. The prevalence of fertility information needs that are unmet remains high at around 40% amongst cancer survivors. Research evaluating the effectiveness of DAs in survivorship is lacking. This is a parallel group double-blind randomised controlled trial for parents and Child Adolescent and Young Adults (CAYA) cancer survivors assessing the Fertility Preservation Decision Aid (FP DA) when provided in conjunction with high-quality information. Eligible participants will be randomly allocated to either a control group receiving high-quality information or a treatment group that will receive the FP DA in addition to high-quality information. Participants will be blinded to their group allocation as they will be instructed to review information regarding fertility preservation without informing them of the type of information they are reviewing.

Conditions

• Unmet Fertility Information Needs

Interventions

Type	Name	Description
OTHER	Decision-aid	Decision Aids (DA) are evidence-based clinical tools developed for patients to supplement clinicians' discussions and facilitate difficult preference-sensitive decisions. They are the gold standard approach (recommended by the Australian Commission of Safety and Quality in Healthcare) to facilitate complex healthcare decisions where there is more than one reasonable choice and where patients may value benefits and risks differently.

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-03-25
• Last updated: 2025-12-16

Locations

1 site across 1 country: Australia