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.
Be able to communicate in English.
Signed written informed consent form.
CAYA cancer survivors aged 16 years or over who have completed curative gonadotoxic treatment.
Participants can be on long-term adjuvant or endocrine therapy.
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.
Parallel
Decision-aid
Other interventionDecision 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.
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.
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.
Change in fertility knowledge as measured using a purposively designed knowledge scale within 8 weeks of randomisation and at 6 months post-randomisation
Changes in fertility knowledge will be measured using a purposively designed knowledge scale within 8 weeks of randomisation and at 6 months after randomisation. The knowledge scale that ranges from 0 to 6, with higher values indicated better knowledge.
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
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.
Change in decisional conflict as measured by the a validated decisional conflict scale within 8 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 \[feels extremely unsupported in decision making\].
Changes in perceived usefulness of the information resources measured by a 5-item Decision Aid development scale at the time of diagnosis
A five-point scale, ranging from 0 to 4, adapted from a Decision Aid (DA) development study will be used to assess the perceived usefulness of the information resources as a decision-making tool and whether it would have been helpful at the time of diagnosis. The higher scores will indicate greater perceived usefulness.
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Murdoch Childrens Research Institute
Lead sponsor
University of Melbourne
Collaborator
