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

NCT06894810 | Recruiting

• 1 other identifier: HREC 107901
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unmet Fertility Information Needs

Keywords

Fertility preservation; Child Adolescent and Young Adults; Decision Aid; CAYA; Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• Unmet information needs as measured by the Unmet Information Needs Scale within 8 weeks of randomisation

  Unmet information needs will be measured within 8 weeks post-randomisation using the Unmet Information Needs Scale. Items included in the questionnaire are: knowledge regarding fertility status, future parenthood goals, and information regarding fertility preservation procedures carried out at either the treatment or survivorship period. Needs are assessed on a 6-point scale, ranging from 0 to 5, with higher scores indicating greater unmet information needs.

  within 8 weeks from randomisation

Secondary Outcomes (16)

• Change in unmet fertility information needs as measured by questionnaire at 6 months post-randomisation

  6 months post-randomisation

• Change in fertility knowledge as measured using a purposively designed knowledge scale within 8 weeks of randomisation and at 6 months post-randomisation

  within 8 weeks of randomisation, 6 months after randomisation

• Change in decision making preparedness regarding fertility preservation measured by the Preparation for Decision Making Scale within 8 weeks of randomisation and at 6 months post-randomisation

  within 8 weeks of randomisation, 6 months after randomisation

• Change in decisional conflict as measured by the a validated decisional conflict scale within 8 weeks of randomisation and at 6 months post-randomisation

  within 8 weeks and 6 months after randomisation

• Change in feasibility and acceptability of the information resources measured using a validated feasibility and acceptability scale within 8 weeks of randomisation and at 6 months post-randomisation

  within 8 weeks of randomisation, 6 months after randomisation

Other Outcomes (1)

• Changes in perceived usefulness of the information resources measured by a 5-item Decision Aid development scale at the time of diagnosis

  within 8 weeks of randomisation, 6 months after randomisation

Study Arms (2)

Decision aid group

ACTIVE COMPARATOR

Participants will have access to fertility preservation Decision Aid (DA) in addition to high-quality information (intervention group).

Other: Decision-aid

CanTeen group

NO INTERVENTION

Participants will have access to high-quality information from CanTeen website (Control group).

Interventions

Decision-aid OTHER

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.

Decision aid group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to communicate in English.
• 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.

You may not qualify if:

• 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.
• Minors who are not deemed to be mature minors as per protocol

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• University of Melbourne: collaborator

Study Sites (1)

Murdoch Children's Research Institute

Melbourne, Victoria, 3052, Australia

RECRUITING

Related Publications (4)

• 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.

  PMID: 29084865 RESULT

• 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.

  PMID: 25958108 RESULT

• 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.

  PMID: 29040512 RESULT

• 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.

  PMID: 37695291 RESULT

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Diana Navarro-Perez, PhD

CONTACT

+61 430 734 262; d.navarroperez@unimelb.edu.au

Yasmin Jayasinghe, FRANZCOG, PhD

CONTACT

yasmin.jayasinghe@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 25, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)