Unmet Fertility Information NeedsFOCUSNCT06894810
Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
A study testing Decision-aid in people with Unmet Fertility Information Needs, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Unmet Fertility Information Needs
- What is being tested?
- Decision-aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Dec 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be able to communicate in English.
- Signed written informed consent form.
- Parents/guardians of CAYA survivors who were ≤25 years (2) 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasmin Jayasinghe, FRANZCOG, PhD contact
Australia1 site, 1 recruiting
- Recruiting
Murdoch Children's Research Institute
Melbourne, Victoria, 3052
Zobaida Edib, MBBS, MPH, PhD, +61 470 630 182, edibz@unimelb.edu.au
Yasmin Jayasinghe, yasmin.jayasinghe@unimelb.edu.au
About this study
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
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.
Read the 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.
- Conditions
- Unmet Fertility Information Needs
- Being tested
- Decision-aid
- Keywords
- Fertility preservation, Child Adolescent and Young Adults, Decision Aid, CAYA, Cancer Survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid group | Active comparator | Participants will have access to fertility preservation Decision Aid (DA) in addition to high-quality information (intervention group). Receives: Other: Decision-aid |
| CanTeen group | No intervention | Participants will have access to high-quality information from CanTeen website (Control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 8 weeks from randomisation
Secondary outcomes (16)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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].
Measured: 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
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.
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 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).
Measured: within 8 weeks of randomisation, 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start8 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unmet Fertility Information NeedsStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894810
- Sponsor's protocol ID
- HREC 107901
- Acronym
- FOCUS
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The current protocol states that data will not be shared. The protocol will be modified in due course to include data sharing and the record will be updated to reflect this.
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.
PubMed 29084865Turcotte 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.
PubMed 25958108Lehmann 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.
PubMed 29040512Benedict 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.
PubMed 37695291
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06894810
- Acronym / sponsor ID
- FOCUS / HREC 107901
- Conditions
- Unmet Fertility Information Needs
- Keywords
- Fertility preservation, Child Adolescent and Young Adults, Decision Aid, CAYA, Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- University of Melbourne
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid group | Active comparator | Other: Decision-aidParticipants will have access to fertility preservation Decision Aid (DA) in addition to high-quality information (intervention group). |
| CanTeen group | No intervention | –Participants will have access to high-quality information from CanTeen website (Control group). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to communicate in English.
- Signed written informed consent form.
- Parents/guardians of CAYA survivors who were ≤25 years (2) 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.
Key exclusion criteria (4 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision-aidDecision 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. | Other | Decision aid group |
Primary outcome
Unmet information needs as measured by the Unmet Information Needs Scale within 8 weeks of randomisation
Time frame: within 8 weeks from 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.
16 secondary outcomes
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
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- heatmap
Time frame: within 8 weeks of randomisation, 6 months after randomisation
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- individual page rating
Time frame: within 8 weeks of randomisation, 6 months after randomisation
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- the proportion of values clarification exercises completed
Time frame: within 8 weeks of randomisation, 6 months after randomisation
Change in Fertility Preservation Decision Aid (FP DA) usage analytic- the responses to the exercises
Time frame: within 8 weeks of randomisation, 6 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 29084865McDougall 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.
- Results publication: PubMed 25958108Turcotte 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.
- Results publication: PubMed 29040512Lehmann 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.
- Results publication: PubMed 37695291Benedict 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.
- Individual participant dataSharing planned: No. The current protocol states that data will not be shared. The protocol will be modified in due course to include data sharing and the record will be updated to reflect this.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasmin Jayasinghe, FRANZCOG, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision-aid in people with Unmet Fertility Information Needs, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Navarro-Perez, PhD (+61 03 8345 3721, d.navarroperez@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unmet information needs as measured by the Unmet Information Needs Scale within 8 weeks of randomisation (time frame: within 8 weeks from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06894810, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.