None listed
Conditions
Brief summary
Brief description of the study purpose The study aims to Investigate the psychosocial and behavioural impact of genetic testing for familial melanoma. It also evaluates a training program for clinicians to provide genetic testing for familial melanoma, based on participant satisfaction. Who is it for? You may be eligible for this study if you are 18 years or older, with 3 primary melanomas and/or a family member with 1 or more invasive melanomas and 2 or more other invasive melanomas and/or pancreatic cancer among first-degree or second-degree relatives on the same side of the family. Study details Participation in the study will involve a pre-testing genetic counselling and education visit. You will be seen by either a genetic counsellor (standard practice of care), or by a clinician who has received training to provide genetic testing (the 'intervention group'). Participants will then have their saliva collected for genetic testing, and will attend a second visit to receive their test results. At both visits, participants will be asked to complete questionnaires (approx 30 mins). One month after receiving their genetic test results, participants will asked to complete a phone interview where questions about their experience in the study will be discussed. Participants will also be required to answer questionnaires about the psychological impact of genetic testing and regarding their sun protective behaviour after results have been received. A link to the questionnaires will be emailed to participants at 1 week, 3 months and 12 months after receiving their results, and can be completed online. It is hoped this study will provide greater insight into the role of genetic testing and the impact on mental health, and sun protective behaviour.
Interventions
The intervention in this study is receiving pre- and post-test genetic consultation for Familial Melanoma, from a clinician who has been trained in this study to provide genetic testing.
Before genetic testing is requested, study participants will attend a pre-testing genetic education and counselling session led by either a genetic counsellor (control group), or a dermatologist trained clinician who has been trained by a genetic counsellor (intervention group). During this session participant
The intervention in this study is receiving pre- and post-test genetic consultation for Familial Melanoma, from a clinician who has been trained in this study to provide genetic testing. Before genetic testing is requested, study participants will attend a pre-testing genetic education and counselling session led by either a genetic counsellor (control group), or a dermatologist trained clinician who has been trained by a genetic counsellor (intervention group). During this session participants can ask any questions and will receive education on genetics, the likelihood of detecting a mutation (based on medical/family history), and the possible impact on family members. At the end of this session, participants will decide if they wish to go ahead with genetic testing. For consenting participants, a saliva sample will be collected using a DNA self-collection kit (at the end of the first visit). This sample is sent to an accredited genetic testing laboratory in the USA (Invitae) for panel testing of known genes associated with melanoma risk. Genetic test results will be reported back to participants during a second (face-to-face) appointment with the genetic counsellor (control group) or clinician trained by a genetic counsellor (intervention). This will be scheduled between 1-3 months after the first visit, depending on when results are available and the availability of staff and participants. This session will include; reporting of results, explanation of significance for personal risk, significance for family risk, recommended preventative health behaviour and screening, and to answer any participant questions.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 3 primary melanomas in an individual, and/or - families with 1 or more invasive melanoma AND 2 or more other invasive melanomas and/or pancreatic cancer among first-degree or second-degree relatives on the same side of the family
Exclusion criteria
Under 18 years
Outcome results
None listed