Participants will be recruited via breast clinics in two oncology centres. Patients will be provided with a study pack containing information about the study. If in clinic, the patient can complete an expression of interest form and a saliva/blood sample will be stored until consent to the study is received. The consent form and saliva sample can be completed at home and sent to the study team.~On receipt of a signed study consent form, the local site will confirm the patient's eligibility and enter details required for study conduct onto the BRCA-DIRECT databases.~After 24 hours, the participant will be sent a link to the BRCA-DIRECT study platform interface. This link enables the participant to progress through the study or withdraw if they have changed their mind.~Participants will be randomised 1:1 to receive either:~Telephone consultation with a genetic counsellor (standard of care) The telephone consultations will be as per standard practice of the qualified genetic counsellor delivering the pre-test information.~Digital delivery of pre-test information via BRCA-DIRECT platform (intervention)~Participants will receive a link to the digital pre-test information. This will consist of text covering:~Genetics and cancer risk~Genetics testing~What will happen if your test is positive~What will happen if your test is negative~Implications for insurance~All participants will have access to a Genetic Counsellor hotline at all stages of the process.~For both arms, if a participant decides to proceed with the genetic test they will sign a digital 'BRCA-test consent' form, which will be formatted to BSGM (British Society of Genomic Medicine) standards. All participants will receive a copy of their signed BRCA-test consent form via secure email/post. The participant will have two days following test-consent to reverse the decision to proceed with the BRCA-test. Beyond those two days, the test will proceed.~The laboratory testing is a standard UK NHS (National Health Service) genetic test. This is delivered for both the intervention arm and the standard-of-care arm.~Participants with a negative (normal) genetic test result will be randomised to receive results either digitally, or via telephone consultation with the Genetic Counsellor. Any individuals with a positive result will receive their result by telephone. Following delivery of results, a results letter and copy of the pathology report will be sent to the participant and their medical team.~The participants will be invited to complete Quality of Life questionnaires, a knowledge test and satisfaction survey at various time points throughout the study via the BRCA-DIRECT platform.
BRCA-DIRECT is a pragmatic, randomised, non-inferiority evaluation that aims to evaluate whether digital delivery of pre-test information for BRCA-testing in breast cancer patients is non-inferior to current standard practice of 1:1 delivery from a healthcare professional as measured by rate of uptake of the genetic testing.