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

Murdoch Childrens Research Institute

Status: Enrolling

Conditions: Unmet Fertility Information Needs

Treatments: Other: Decision-aid

Study type: Interventional

Funder types: Other

Identifiers

NCT06894810

HREC 107901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 358 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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358 participants in 2 patient groups

Decision aid group

Active Comparator group

Description:

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

Treatment:

Other: Decision-aid

CanTeen group

No Intervention group

Description:

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