Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
NCT ID: NCT06894810
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
358 participants
INTERVENTIONAL
2025-12-08
2026-07-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Decision aid group
Participants will have access to fertility preservation Decision Aid (DA) in addition to high-quality information (intervention group).
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.
CanTeen group
Participants will have access to high-quality information from CanTeen website (Control group).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent form.
• Parents/guardians of CAYA survivors who were ≤25 years (2) when diagnosed with cancer and have completed curative gonadotoxic treatment
* 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
* CAYA patients who are palliative and their parents/guardians
* A family member already in the study.
• Minors who are not deemed to be mature minors as per protocol
16 Years
ALL
No
Sponsors
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University of Melbourne
OTHER
Murdoch Childrens Research Institute
OTHER
Responsible Party
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Locations
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Murdoch Children's Research Institute
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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McDougall RJ, Gillam L, Delany C, Jayasinghe Y. Ethics of fertility preservation for prepubertal children: should clinicians offer procedures where efficacy is largely unproven? J Med Ethics. 2018 Jan;44(1):27-31. doi: 10.1136/medethics-2016-104042. Epub 2017 Oct 30.
Turcotte S, Guerrier M, Labrecque M, Robitaille H, Rivest LP, Hess B, Legare F. Dyadic validity of the Decisional Conflict Scale: common patient/physician measures of patient uncertainty were identified. J Clin Epidemiol. 2015 Aug;68(8):920-7. doi: 10.1016/j.jclinepi.2015.03.005. Epub 2015 Mar 21.
Lehmann V, Keim MC, Nahata L, Shultz EL, Klosky JL, Tuinman MA, Gerhardt CA. Fertility-related knowledge and reproductive goals in childhood cancer survivors: short communication. Hum Reprod. 2017 Nov 1;32(11):2250-2253. doi: 10.1093/humrep/dex297.
Benedict C, Stal J, Davis A, Zeidman A, Pons D, Schapira L, Diefenbach M, Ford JS. Greater fertility distress and avoidance relate to poorer decision making about family building after cancer among adolescent and young adult female survivors. Psychooncology. 2023 Oct;32(10):1606-1615. doi: 10.1002/pon.6212. Epub 2023 Sep 11.
Other Identifiers
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HREC 107901
Identifier Type: -
Identifier Source: org_study_id