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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06894810




Registration number
NCT06894810
Ethics application status
Date submitted
20/02/2025
Date registered
25/03/2025

Titles & IDs
Public title
Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
Scientific title
A Double Blind Randomised Controlled Trial of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
Secondary ID [1] 0 0
HREC 107901
Universal Trial Number (UTN)
Trial acronym
CAYA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unmet Fertility Information Needs 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Decision-aid

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

No intervention: CanTeen group - Participants will have access to high-quality information from CanTeen website (Control group).


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Unmet information needs as measured by the Unmet Information Needs Scale within 4 weeks of randomisation
Timepoint [1] 0 0
within 4 weeks randomisation
Secondary outcome [1] 0 0
Change in unmet fertility information needs as measured by questionnaire at 6 months post-randomisation
Timepoint [1] 0 0
6 months post-randomisation
Secondary outcome [2] 0 0
Change in fertility knowledge as measured using a purposively designed knowledge scale within 4 weeks of randomisation and at 6 months post-randomisation
Timepoint [2] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [4] 0 0
Change in decisional conflict as measured by the a validated decisional conflict scale within 4 weeks of randomisation and at 6 months post-randomisation
Timepoint [4] 0 0
within 4 weeks and 6 months after randomisation
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [6] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- bounce rate
Timepoint [6] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [7] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- average session duration
Timepoint [7] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [8] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- average time on pages
Timepoint [8] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [9] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- pages view per visit
Timepoint [9] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [10] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- user behavior flow
Timepoint [10] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [11] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- exit rate
Timepoint [11] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [12] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- returning users
Timepoint [12] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [13] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- heatmap
Timepoint [13] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [14] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- individual page rating
Timepoint [14] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [15] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- the proportion of values clarification exercises completed
Timepoint [15] 0 0
within 4 weeks of randomisation, 6 months after randomisation
Secondary outcome [16] 0 0
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- the responses to the exercises
Timepoint [16] 0 0
within 4 weeks of randomisation, 6 months after randomisation

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/04/2026
Actual
Sample size
Target
358
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zobaida Edib, MBBS, MPH, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 470 630 182
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06894810