Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Be able to communicate in English.
- Signed written informed consent form.
- Parents/guardians of CAYA survivors who were ≤25 years 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 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
OTHER
Phase
- NA
Study ID
NCT06894810
Intervention or treatment
OTHER: Decision-aid
Conditions
- Unmet Fertility Information Needs
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Research sites nearby
Closest Location:
Murdoch Children's Research Institute
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Murdoch Children's Research Institute
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Murdoch Childrens Research Institute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Decision aid group
| Other: Decision-aid |
NO_INTERVENTION: CanTeen group
|
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Unmet information needs as measured by the Unmet Information Needs Scale within 4 weeks of randomisation | Unmet information needs will be measured within 4 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 4 weeks randomisation |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in unmet fertility information needs as measured by questionnaire at 6 months post-randomisation | Unmet fertility information needs will be measured at 6 months 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. | 6 months post-randomisation |
| Change in fertility knowledge as measured using a purposively designed knowledge scale within 4 weeks of randomisation and at 6 months post-randomisation | Changes in fertility knowledge will be measured using a purposively designed knowledge scale within 4 weeks of randomisation and at 6 months after randomisation. The knowledge scale that ranges from 0 to 6, with higher values indicated better knowledge. | within 4 weeks of randomisation, 6 months after randomisation |
| Change in decision making preparedness regarding fertility preservation measured by the Preparation for Decision Making Scale within 4 weeks of randomisation and at 6 months post-randomisation | Preparation for decision making will be measured by the utility of the information provided by participants using the Preparation for Decision Making Scale. The preparation for decision making scaling regarding fertility preservation comprises a 10 item scale with each answer scored 1 (not at all) to 5 (a great deal). The 10 items are summed and divided by 10. A higher score reflects greater preparation for decision making. | within 4 weeks of randomisation, 6 months after randomisation |
| Change in decisional conflict as measured by the a validated decisional conflict scale within 4 weeks of randomisation and at 6 months post-randomisation | Decisional conflict is defined as uncertainty around the decision to see a health professional for further advice about sexual and reproductive health and uncertainty around choices available to achieve parenthood. This will be measured using a validated decisional conflict scale. Scores range from 0 \[feels extremely supported in decision making\] to 100 \[feels extremely unsupported in decision making\]. | within 4 weeks and 6 months after randomisation |
| Change in feasibility and acceptability of the information resources measured using a validated feasibility and acceptability scale within 4 weeks of randomisation and at 6 months post-randomisation | Feasibility and acceptability of using the information resources will be measured using a validated feasibility and acceptability scale. They are assessed on a 5-point scale, ranging from 1 to 5, with higher scores indicating greater feasibility and acceptability. | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- bounce rate | FP DA usage analytic- bounce rate will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- average session duration | FP DA usage analytic- average session duration will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- average time on pages | FP DA usage analytic- average time on pages will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- pages view per visit | FP DA usage analytic- total number of pages view across the website per visit will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- user behavior flow | FP DA usage analytic- user behavior flow will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- exit rate | FP DA usage analytic- exit rate will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- returning users | FP DA usage analytic- returning users will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- heatmap | FP DA usage analytic- heatmap will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- individual page rating | FP DA usage analytic- individual page rating will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- the proportion of values clarification exercises completed | FP DA usage analytic- the proportion of values clarification exercises completed will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
| Change in Fertility Preservation Decision Aid (FP DA) usage analytic- the responses to the exercises | FP DA usage analytic- the responses to the exercises completed will be collected using a first-party analytics provider (Mixpanel). | within 4 weeks of randomisation, 6 months after randomisation |
References
Clinical Trials Gov: Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer SurvivorsOther trials to consider
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