None listed
Conditions
Brief summary
The purpose of this study is to determine whether providing personalised melanoma (skin cancer) risk information based on genetic and other lifestyle factors has any influence on sun protection and skin cancer prevention behaviours in Australian adults. Who is it for? You may be eligible for this study if you are aged 18 or over and have previously enrolled in the Australasian Centre of Excellence in Melanoma Imaging and Diagnosis study (ACTRN12619001706167). Note, that you do not need to have been diagnosed with skin cancer or be at risk of skin cancer to participate in this study. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will receive personalised melanoma risk information as an electronic booklet, based on a genetic sample and additional information provided as part of the Australasian Centre of Excellence in Melanoma Imaging and Diagnosis study. Participants allocated to the second group will receive standard melanoma prevention information, based on the available guidance from the Cancer Council. Participants in both groups will be asked to complete online questionnaires at the time they enrol, and then at 3 months and 12 months after enrolment. Participants who are allocated to the second group will then be offered the option to receive a personalised melanoma risk booklet after they have completed their final questionnaires at 12 months. It is hoped this research will improve participants' willingness to engage in melanoma prevention and sun protection behaviours, which could reduce their risk of melanoma.
Interventions
Participants will receive a personalised melanoma risk assessment based on the integration of genetic and clinical risk factors. Genetic risk will be derived from analysis of multiple common genetic variants associated with melanoma susceptibility (polygenic risk), and, where applicable, testing for rare high-risk genetic variants. Clinical risk factors will include established predictors such as pigmentary characteristics, naevus density, personal and family history of skin cancer, and sun expo
Participants will receive a personalised melanoma risk assessment based on the integration of genetic and clinical risk factors. Genetic risk will be derived from analysis of multiple common genetic variants associated with melanoma susceptibility (polygenic risk), and, where applicable, testing for rare high-risk genetic variants. Clinical risk factors will include established predictors such as pigmentary characteristics, naevus density, personal and family history of skin cancer, and sun exposure history. These data will be combined to generate an individualised melanoma risk estimate, which will be communicated to participants via a personalised risk information booklet. The booklet will present risk in both absolute and comparative formats and include tailored recommendations for sun protection and skin surveillance. Participants will receive the booklet electronically via email. Individuals identified as higher risk will be offered the opportunity to discuss their results with a qualified genetic counsellor prior to or following receipt of the booklet, as outlined in the participant information and consent form. The intervention is delivered once following risk calculation, with no ongoing administration. Outcomes will be assessed via follow-up questionnaires at specified timepoints. Polygenic risk assessment will utilise existing genetic data derived from saliva samples previously collected through the ACEMID study. No additional biological samples are required for this study. All assessment components are completed remotely via online questionnaires; no in-person study visits are required. Questionnaire completion is expected to take ~15–20 minutes per timepoint. Risk assessment is based on a pre-specified, validated integrated model (PRS + clinical factors ± monogenic risk); no novel model will be developed. Personalised risk booklets will be emailed within 7 days of completing baseline questionnaires. Booklets are ~8–12 pages and take ~10–15 minutes to read. Intervention participants will have access to a genetic counselling consultation via telehealth (videoconference or telephone) upon request. The consultation will include explanation of genetic and clinical risk, interpretation of the personalised risk score, and discussion of melanoma prevention strategies. No additional study-mandated skin surveillance appointments are required; participants continue usual care. Email delivery will be monitored via institutional email systems (e.g. confirmation of successful transmission and, where available, read receipts or equivalent functionality).
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Adults aged 18 years or older Current participants in the Australasian Centre of Excellence in Melanoma Imaging and Diagnosis study (ACTRN12619001706167) Have provided a saliva sample for genetic analysis Have consented to be contacted about future research Classified as eligible for this sub-study based on melanoma risk stratification using genetic and clinical risk information Able to read and understand English sufficiently to provide informed consent and complete study questionnaires Able to provide informed consent
Exclusion criteria
Individuals who have already received personalised melanoma risk information as part of this study or a related study
Outcome results
None listed