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

Study acronym: FOCUS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Jul 2026 → Jun 2027
See other at-risk trials from Murdoch Childrens Research Institute

Record History

  1. Primary and study completion pushed from Jul 2026 to Jun 2027v5
  2. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Start date changed from estimate of Nov 2025 to Dec 8, 2025 · Secondary endpoints revised (16) · 2 morev4 Show 5 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Nov 2025 to Dec 8, 2025
    • Secondary endpoints revised (16)
    • Site details revised
    • Publications: details revised at 4 of 4 entries

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jul 2025 to Nov 2025v3
  4. Start date: Apr 28, 2025 to Jul 2025 Primary and study completion dates: Apr 28, 2026 to Jul 2026v2 Show 1 more changeShow less
    • Primary and study completion dates: Apr 28, 2026 to Jul 2026
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06894810
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: University of Melbourne
Conditions Unmet Fertility Information Needs
Enrollment 358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov