Fertility-preservation decision aid for parents and adolescent and young adult 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
This research tests whether adding a fertility preservation decision aid to standard information helps parents and adolescent and young adult cancer survivors better meet their fertility information needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06894810 on ClinicalTrials.gov |
What this trial studies
This is a parallel-group, double-blind randomized controlled trial comparing standard high-quality information alone versus the same information plus a Fertility Preservation Decision Aid (FP DA) for parents and CAYA cancer survivors. Eligible participants are English-speaking parents of survivors diagnosed at age 25 or younger and survivors aged 16 or older who have completed curative gonadotoxic treatment. Participants are randomized to one of the two arms and instructed to review their assigned materials while blinded to allocation; primary outcomes include unmet fertility information needs, understanding of fertility status, and decision-making about fertility testing, storage, and use of gametes. The study is run at Murdoch Children's Research Institute in Melbourne with University of Melbourne collaboration.
Who should consider this trial
Good fit: English-speaking parents/guardians of CAYA survivors diagnosed at age ≤25 and CAYA survivors aged 16 years or older who have completed curative gonadotoxic cancer treatment are ideal candidates.
Not a fit: Patients currently undergoing cancer treatment, those receiving palliative care, non-English speakers, minors not deemed mature per protocol, and family members already enrolled are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the decision aid could improve survivors' and parents' understanding of fertility risks and options and reduce missed opportunities for preservation or timely decision-making.
How similar studies have performed: Decision aids have shown benefits in other medical decision contexts, but their specific use for fertility information in cancer survivorship is novel and evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria for both parents and survivors: * Be able to communicate in English. * Signed written informed consent form. Inclusion Criteria for parents only: • Parents/guardians of CAYA survivors who were ≤25 years (2) when diagnosed with cancer and have completed curative gonadotoxic treatment Inclusion Criteria for survivors only * CAYA cancer survivors aged 16 years or over who have completed curative gonadotoxic treatment. * Participants can be on long-term adjuvant or endocrine therapy. * Participants may have achieved a pregnancy or livebirth. Exclusion Criteria: Exclusion Criteria for both parents and survivors: * CAYA patients currently undergoing cancer treatment and their parents/guardians. * CAYA patients who are palliative and their parents/guardians * A family member already in the study. Exclusion Criteria for survivors only: • Minors who are not deemed to be mature minors as per protocol
Where this trial is running
Melbourne, Victoria
- Murdoch Children's Research Institute — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Diana Navarro-Perez, PhD
- Email: d.navarroperez@unimelb.edu.au
- Phone: +61 430 734 262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.