Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unmet Fertility Information Needs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision-aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Decision aid group
- description
- Participants will have access to fertility preservation Decision Aid (DA) in addition to high-quality information (intervention group).
- interventionNames
- Other: Decision-aid
- type
- NO_INTERVENTION
- label
- CanTeen group
- description
- Participants will have access to high-quality information from CanTeen website (Control group).
Primary outcomes (1)
- measure
- Unmet information needs as measured by the Unmet Information Needs Scale within 8 weeks of randomisation
- timeFrame
- within 8 weeks from randomisation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTMcDougall 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
- RESULTTurcotte 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
- RESULTLehmann 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
- RESULTBenedict 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