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

Official title

A Double Blind Randomised Controlled Trial of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors

Overview

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.

Detailed description

Medical advances over recent decades have increased the overall survival rates of children, adolescents and young adults diagnosed with cancer, with survival rates now exceeding 80%. The pressure points are not only at diagnosis - research has shown that cancer treatment can potentially affect fertility later in life. Survivorship is an important time for addressing the following issues: fertility status, reproductive monitoring, decisions about interval fertility preservation, ongoing tissue storage and utilization. Options to preserve fertility are possible. Decision Aids (DA) have been developed to provide patients and their families with the required information to make informed reproductive health decisions that align with their values. The prevalence of fertility information needs that are unmet remains high at around 40% amongst cancer survivors. Research evaluating the effectiveness of DAs in survivorship is lacking.

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.

Interventions

• Other 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.

Primary outcome measures

• Unmet information needs as measured by the Unmet Information Needs Scale within 8 weeks of randomisation [Time frame: within 8 weeks from randomisation]

Secondary outcome measures (12)

• Change in unmet fertility information needs as measured by questionnaire at 6 months post-randomisation [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: within 8 weeks of randomisation, 6 months after randomisation]
• Change in Fertility Preservation Decision Aid (FP DA) usage analytic- bounce rate [Time frame: within 8 weeks of randomisation, 6 months after randomisation]
• Change in Fertility Preservation Decision Aid (FP DA) usage analytic- average session duration [Time frame: within 8 weeks of randomisation, 6 months after randomisation]
• Change in Fertility Preservation Decision Aid (FP DA) usage analytic- average time on pages [Time frame: within 8 weeks of randomisation, 6 months after randomisation]
• Change in Fertility Preservation Decision Aid (FP DA) usage analytic- pages view per visit [Time frame: within 8 weeks of randomisation, 6 months after randomisation]
• Change in Fertility Preservation Decision Aid (FP DA) usage analytic- user behavior flow [Time frame: within 8 weeks of randomisation, 6 months after randomisation]
• Change in Fertility Preservation Decision Aid (FP DA) usage analytic- exit rate [Time frame: within 8 weeks of randomisation, 6 months after randomisation]
• Change in Fertility Preservation Decision Aid (FP DA) usage analytic- returning users [Time frame: within 8 weeks of randomisation, 6 months after randomisation]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Australia · 1 center

• Murdoch Children's Research Institute — Melbourne

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06894810 · HREC 107901

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗