Feasibility trial of delivering breast and ovarian cancer risk assessment to young people in the general population

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.