Protocol for a Randomised Controlled Trial to evaluate psychosocial and behaviour impact of providing personalised risk scores for melanoma
- Conditions
- melanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12624000707561
- Lead Sponsor
- The University of Queensland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 145
This is a sub-study from a larger trial (ACTRN12619001706167). This study will recruit 360 individuals in a longitudinal two-arm randomised controlled, single-blind trial. Individuals are recruited from a cohort of previous and existing study participants within the Australian Centre of Excellence in Melanoma Imaging and Diagnosis (ACEMID) Study (ethical approval reference: HREC/2019/QMS/57206). The setting is at the Princess Alexandra Hospital located in Brisbane, Queensland, Australia. Participants in this study represented various risk levels (low, moderate, and high risk) and range from 18 years old and up. Any participant who has previously provided a saliva sample for genetic analysis, and consented to be contacted for future research are eligible to be recruited to the present study.
If not already enrolled in parent (ACEMID) trial, individuals are not eligible to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Personal utility of receiving personalised (PRS) vs traditional risk scores for melanoma using quantitative and qualitative outcomes. This a composite primary outcome.[Quantitative assessment relies on the Personal Utility Scale, which has been previously validated and we will re-validate within our cohort. <br>Qualitative assessment will include semi-structured interviews at 12 months. One month post receipt of results]
- Secondary Outcome Measures
Name Time Method