None listed
Conditions
Brief summary
This research is testing if telling a person their risk of melanoma based on either their clinical risk factors or their genetic risk factors influence their skin screening behaviours. Who is it for? You may be eligible for this study if you are a healthy adult aged between 51 and 75 years old (inclusive) at the time of informed consent with no history of invasive or in situ melanoma. You must have also previously participated QSkin Sun and Health Study. Study details Participants will be randomly allocated to either of the two intervention groups who will receive one of the personal melanoma risk scores along with general skin health education, or the control group who will not be given a risk score and will only receive general education. Data on their screening habits and behaviours will be followed up over a one-year period. It is hoped that findings from this study will help inform potential screening programs for melanoma.
Interventions
We plan a 3-arm blinded RCT to assess the effect of personalised genetic or clinical risk for skin cancer on skin screening behaviour. Participants currently participating in the QSkin trial will be recruited. Participants will be randomly assigned to a clinical risk score, genetic risk score or control group. Intervention will be sent as a PDF booklet via email to participants. All participants regardless of group assignment will receive in the PDF booklet general education which will cover app
We plan a 3-arm blinded RCT to assess the effect of personalised genetic or clinical risk for skin cancer on skin screening behaviour. Participants currently participating in the QSkin trial will be recruited. Participants will be randomly assigned to a clinical risk score, genetic risk score or control group. Intervention will be sent as a PDF booklet via email to participants. All participants regardless of group assignment will receive in the PDF booklet general education which will cover appropriate Cancer-Council recommended guidelines on how to identify a lesion of concern and sun-protection. This will be generated by study team in collaboration with the QSkin consumer advisory group. Participants will be required to confirm that that have read the intervention materials in full. They will also be able to access the materials at any time over the course of the trial. The clinical risk score intervention will be provided their clinical risk as per the QSkin Risk Melanoma Calculator (MP16 model). Clinical Risk Scores have previously been calculated for eligible participants as part of QSkin trial. Participants will be scored based on previously supplied risk factor information including their age, sex, ancestry, hair colour, number of naevi (moles), sunburn as an adult, history of skin and other cancers, freckling, tanning ability and smoking information. This risk score will be given presented as an absolute risk (percentage) and risk relative to others of the same age and sex. Participants will then be distributed RACGP recommended skin screening guidance specific to their risk status (high risk or low risk). The genetic risk score be provided with their individual polygenic risk scores (PRS) previously calculated for QSkin Cohort participants who participated in the QSkin Genetics Project, where they provided saliva samples for DNA extracting and genotyping. PRS was then derived using SBayesRC method. This risk score will be given presented as an absolute risk (percentage) and risk relative to others of the same age and sex. Participants will then be distributed RACGP recommended skin screening guidance specific to their risk status (high risk or low risk)
Sponsors
QIMR Berghofer
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
51 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1.Provide signed and dated informed consent form 2.Willing to comply with all study procedures and be available for the duration of the study 3.Genetic data available in QSkin 4. Genetically be of European ancestry 5. Be male or female between 51 and 75 years old (inclusive) at the time of informed consent 6. No history of invasive or in situ melanoma
Exclusion criteria
1. Do not own a telephone (either mobile or landline registered to participant) 2.Are unable to access electronic device to complete required survey data and receiving emails
Outcome results
None listed