Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001087347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/07/2026
Date registered
Help: Date registered
3/09/2026
Date last updated
Help: Date last updated
3/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility trial of delivering breast and ovarian cancer risk assessment to young people in the general population
Scientific title
Testing the feasibility of PERSONA (Precision prevention of bReaSt and OvariaN cAncer): A shared care model delivering multifactorial breast and ovarian cancer risk assessment to young people in the general population
Additional trial identifiers [1] 317925 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PERSONA (Precision prEvention of bReaSt and OvariaN cAncer)
Related trial records

Health condition
Health condition(s) studied:
Breast cancer 342875 0
Ovarian Cancer 343283 0
Condition category
Condition code
Cancer 338990 338990 0 0
Breast
Cancer 338991 338991 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
PERSONA (Precision prEvention of bReaSt and OvariaN cAncer) is a shared care model involving general practitioners (GPs) and genetic counsellors (GCs) who will deliver multifactorial breast and ovarian cancer risk assessment to people aged 20-39 years-old. The participants will be stratified into breast and ovarian cancer risk categories (high, moderate, and population risk) to enable cancer precision prevention. The aim of the PERSONA feasibility trial is to establish whether PERSONA is acceptable, feasible, and appropriate to end-users, guided by the RE-AIM framework for assessing implementation. The trial will assess potential implementation strategy effects on reach, effectiveness, adoption, and implementation outcomes. An early value assessment of PERSONA will also be conducted to establish the clinical potential of PERSONA and explore what is needed to provide the most value for money

This is a 2x2 factorial cluster allocation and randomised feasibility design considering two implementation strategies as experimental factors:

* MODE OF ACCESS TO CANCER RISK ASSESSMENT (cluster-allocation by general practice site). In this comparison, uptake of PERSONA will be compared between populations who are (1) asked to book and appointment to discuss with their GP first or (2) able to self-enrol via an online portal. Allocation of access mode will be determined by the research team such that clinics in different geographic regions (metropolitan, regional, rural) are included in both arms.

* MODE OF RESULTS RETURN (individually randomised within practices). In this comparison, the acceptability of method of results return will be compared, with some consumer participants allocated to (A) receive their results from a participating GP and others allocated to (B) receive their results from a study genetic counsellor.

This trial will therefore assess four intervention pathways in total:
1 - GP-led access with GP results return (Arm 1A)
2 - GP led access with genetic counsellor results return (Arm 1B)
3 - Consumer-led access with GP results return (Arm 2A)
4 - Consumer-led access with genetic counsellor results return (Arm 2B)

Procedures:
Ten GP clinics will be recruited, with five practices allocated to the GP-facilitated access arm (Arm 1) and five allocated to the consumer-led access arm (Arm 2). GPs and clinics will be visited by the study team for an information session prior to contacting eligible consumer participants. Information provided to the GPs and clinics will include the study protocol, information about billing and education about the multifactorial breast and ovarian cancer risk assessment, including the use of DNA testing and how to interpret the reports. GPs at the clinics will be consented to participate in the trial at the information session and the study team will leave information materials (quick reference guides, flyers with QR codes) at the site. GPs will also have ongoing access to an information website developed by the study team, including FAQs.

In Arm 1, eligible consumer participants will be contacted by the clinic via their clinic’s agreed communications approach (SMS or email) and advised of the trial availability with instruction to book an appointment with a participating GP if they would like to join the trial. The appointment can be held face-to-face or via telehealth (video or phone), depending on the GP’s usual practice and consumer participant preference. The appointment will last approximately 20 min and will be bulk billed with any gap fee covered by research funds. The GP will provide information about the trial and outline the risks, benefits and utility of the multifactorial risk assessment and give the consumer a link to the participant information and consent form to enrol if they decide to go ahead.
In Arm 2, eligible consumer participants will be contacted by the clinic via their clinic’s agreed communications approach (SMS or email) and advised of the trial availability with a link to the participant information and consent form to enrol if they decide to go ahead.

In both cases, participants will have access to study genetic counsellors via email for additional information about the trial. Consumer participants will go online to fill out a baseline survey, enter health and family cancer history information and then provide their address to receive a saliva collection kit for DNA testing in the mail. Participants will then send the saliva sample back via return paid mail for genetic testing, looking at monogenic and polygenic changes that predispose to breast and ovarian cancer. Study genetic counsellors will collate the genetic and health history data to generate a breast and ovarian cancer risk assessment. This risk assessment will be summarised into a plain language report which has been developed and tested by the study team in co-design with GPs and genetic counsellors for the purpose of cancer risk communication to the lay population. It includes the participants life-time breast and ovarian cancer risk, information about the risk factors included in the calculation, cancer risk management recommendations, family implications and limitations. It is anticipated that results will be ready to be shared with the consumer participants at 6-8 weeks after they send their saliva sample back for DNA testing.

Consumer participants will be randomised to receive their results from a participating GP at their clinic (Arm A) or a study genetic counsellor (Arm B). Consumer participants will be notified via email that their results are available and to either book an appointment with a GP at their clinic or select an appointment time for the study genetic counsellor to call them. The GP will receive the plain language risk report via email, with notification that a consumer participant has been advised to book a results appointment. The GP appointment can be held face-to-face or via telehealth (video or phone), depending on the GP’s usual practice and consumer participant preference. Results appointments are expected to take 30 minutes and will be bulk billed with gap fees covered by research funds. Appointments with the study genetic counsellors will be via telehealth (video or phone) and are expected to take 30 minutes with no charge to the consumer participant. In both arms, results disclosure will use the plain language report as a basis for sharing the results to ensure consistency in discussion points between the GP and study genetic counsellor appointments. The plain language report will also be made available to the consumer participants at the end of the appointment. Consumer participants will be informed of their 5-, 10-year and life-time risk of developing breast and ovarian cancer. Consumers will be advised of recommended screening/preventative steps and counselled about modifiable risk factors (eg, smoking or alcohol use). If the consumer tests positive to a monogenic risk factor (eg, BRCA1), they will be linked up to the Parkville Familial Cancer Centre for confirmatory testing and additional clinical and psychosocial support.

Consumer participants will be asked to fill out two further online surveys at two weeks and three months post-result delivery to assess whether they thought the intervention was acceptable and psychosocial outcomes (eg, cancer worry). Select participants, including GPs and consumers, will be offered an opportunity to discuss their experience in a qualitative interview over phone or video call. Reminders to complete surveys and tests will be sent twice at two- and four- weeks after the initial request and if participants do not respond they will be assumed to have withdrawn from the trial.

Adherence and fidelity will be tracked, looking at whether there is a preference for enrolment modality, completion of trial requirements (online data collection and genetic testing), whether participants receive their results, if consumers raise preferences about how they receive results and whether consumers act on recommended screening.
Intervention code [1] 334770 0
Early detection / Screening
Intervention code [2] 334773 0
Prevention
Description of the comparator or control
The comparator for this trial is Arm 1A which represents the usual primary care pathway for screening/testing.

Arm 1A is delivered by GPs who have expertise in primary care and preventative population screening programs. The appointment can be held face-to-face or via telehealth (video or phone), depending on the GP’s usual practice and consumer participant preference. The appointment will last approximately 20 min and will be bulk billed with any gap fee covered by research funds. The GP will provide information about the trial and outline the risks, benefits and utility of the multifactorial risk assessment and give the consumer a link to the participant information and consent form to enrol if they decide to go ahead.

Consumer participants will be notified via email that their results are available and told to book an appointment with a GP at their clinic. Consumers will be reminded twice, 2 weeks apart to book an appointment if they haven't made a booking. The GP will receive the plain language risk report via email, with notification that a consumer participant has been advised to book a results appointment. The GP appointment can be held face-to-face or via telehealth (video or phone), depending on the GP’s usual practice and consumer participant preference. Results appointments are expected to take 30 minutes and will be bulk billed with gap fees covered by research funds. Results disclosure will use a plain language report as a basis for sharing the results. The plain language report will also be made available to the consumer participants at the end of the appointment.
Control group
Active

Outcomes
Primary outcome [1] 346227 0
Uptake of the intervention overall and per access strategy.
Timepoint [1] 346227 0
Quantitative data (study data) will be collected at enrolment Quantitative data (interviews) will be undertaken at 4-6 months post results return
Primary outcome [2] 346606 0
Representativeness of enrolled consumer participants overall and per access strategy
Timepoint [2] 346606 0
Enrolment and at study completion
Primary outcome [3] 346608 0
Acceptability of PERSONA
Timepoint [3] 346608 0
Quantitative data (questionnaires) will be collected at 2 weeks post results return, and 3 months post results return. Quantitative data (interviews) will be undertaken at 4-6 months post results return
Secondary outcome [1] 466698 0
Primary Outcome 4 - Appropriateness of PERSONA and the trial procedures
Timepoint [1] 466698 0
3 months post results return
Secondary outcome [2] 466705 0
Primary Outcome 5 - Psychosocial impact of the personalised cancer risk assessment
Timepoint [2] 466705 0
Cancer Risk Perception and Cancer Worry assessments Enrolment, 2 weeks post results return and 3 months post results return Feelings About Genomic Testing Results and Decision Regret assessments 2 weeks post results return and 3 months post results return
Secondary outcome [3] 466709 0
Primary outcome 6 - Clinical outcomes of PERSONA
Timepoint [3] 466709 0
Questionnaire will be at 2 weeks post results return, and 3 months post results return MBS/PBS/BSV data will be collected 5 years post-trial completion (if consented).
Secondary outcome [4] 466714 0
Primary outcome 7 - Adoption of PERSONA by general practices
Timepoint [4] 466714 0
Quantitative data will be collected at enrolment Qualitative interviews will be undertaken at 4-6 months post results return.
Secondary outcome [5] 466715 0
Primary outcome 8 - Fidelity of Implementation
Timepoint [5] 466715 0
Trial records will be assessed at study completion Quantitative survey will be completed at 3 months post results return Qualitative interviews will be completed at 4-6 months after results return
Secondary outcome [6] 466716 0
Secondary Outcome 1 - Research Burden
Timepoint [6] 466716 0
3 months after results return
Secondary outcome [7] 466717 0
Secondary Outcome 2 - Cost and value
Timepoint [7] 466717 0
Ongoing up to 5 years post-trial completion

Eligibility
Key inclusion criteria
GP participants will be eligible for inclusion in this trial if all the following criteria apply:
• Currently working in a community-based practice as a GP
• Are Fellows of the Royal Australian College of General Practitioners (RACGP) or the Australian College of Rural and Remote Medicine (ACRRUM)
• Currently work at one of the ten general practices involved in the trial, identified by the Victorian primary care practice-based Research and Education Network

Consumer participants will be eligible for including in this trial if all the following criteria apply:
• Individuals recorded female at birth
• Aged between 20-39 years-old, inclusive
• Are fluent in verbal and written English
• Competent to give autonomous informed consent
• Registered as a patient at one of the ten general practices involved in the trial, in metropolitan or regional areas of Victoria
• Holds a valid Medicare card
Minimum age
20 Years
Maximum age
39 Years
Sex
Females
Healthy volunteers
Yes
Key exclusion criteria
GP participants will not be eligible for inclusion if any of the following criteria apply:
• Are employed as a GP exclusively in a non-primary care setting

Consumer participants will not be eligible for inclusion if any of the following criteria apply:
• Have been diagnosed with invasive breast, ovarian, or other cancer
• Have a known germline likely pathogenic or pathogenic variant in a hereditary breast and ovarian cancer gene in themselves or their family

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment: Participants will be randomised to receive their results by GP or genetic counsellor. Randomisation will be concealed using central randomisation by computer. via the randomisation module in REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation: Randomisation will be via the randomisation module in REDCap and will use a random number table that ensures the participants are evenly allocated to a results-return pathway (half to GP and half to genetic counsellors).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be allocated to an access pathway dependant on which GP clinic they attend. They will then be randomised to a results return pathway, as below:

MODE OF ACCESS TO CANCER RISK ASSESSMENT (cluster-allocation by general practice site). In this comparison, uptake of PERSONA will be compared between populations who are (1) asked to book and appointment to discuss with their GP first or (2) able to self-enrol via an online portal. Allocation of access mode will be determined by the research team such that clinics in different geographic regions (metropolitan, regional, rural) are included in both arms.

MODE OF RESULTS RETURN (individually randomised within practices). In this comparison, the acceptability of method of results return will be compared, with some consumer participants allocated to (A) receive their results from a participating GP and others allocated to (B) receive their results from a study genetic counsellor.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322460 0
Government body
Name [1] 322460 0
Australian Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF) Genomics Health Futures Grant (GHFM; MRF2045389
Country [1] 322460 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 325390 0
None
Name [1] 325390 0
Address [1] 325390 0
Country [1] 325390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320951 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 320951 0
Ethics committee country [1] 320951 0
Australia
Date submitted for ethics approval [1] 320951 0
06/03/2026
Approval date [1] 320951 0
06/07/2026
Ethics approval number [1] 320951 0
HREC/126843/PMCC

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

Contacts
Principal investigator
Name 152182 0
A/Prof Laura Forrest
Address 152182 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, Victoria, 3000
Country 152182 0
Australia
Phone 152182 0
+61 3 8559 6191
Fax 152182 0
Email 152182 0
[email protected]
Contact person for public queries
Name 152183 0
Laura Forrest
Address 152183 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, Victoria, 3000
Country 152183 0
Australia
Phone 152183 0
+61385596191
Fax 152183 0
Email 152183 0
[email protected]
Contact person for scientific queries
Name 152184 0
Laura Forrest
Address 152184 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne, Victoria, 3000
Country 152184 0
Australia
Phone 152184 0
+61385596191
Fax 152184 0
Email 152184 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared due to potential risk of re-identification. De-identified aggregate data will be reported in publications, presentations and a student final thesis.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.