Protocol for a randomised controlled trial to evaluate the efficacy of 3D Total Body Photography with sequential digital dermoscopy in a high risk melanoma cohort
Background Melanoma is Australia's 4th most common cancer. Early detection is fundamental to maximizing health outcomes and minimizing treatment costs. Population based screening programs have not been justified in health economics studies. However, a screening approach targeting high risk individuals could improve the cost-benefit ratio. Methods and analysis We describe a two year longitudinal randomised controlled trial (RCT) targeted at high risk individuals. It will compare routine clinical care (control) with an intensive skin surveillance program (the intervention) consisting of novel three dimensional (3D) total body photography (TBP), sequential digital dermoscopy and melanoma risk stratification. The primary outcomes will evaluate clinical, economic and consumer impact of the intervention. Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions, and thickness of melanomas diagnosed. A health economic analysis using government data repositories will capture healthcare utilisation and costs relating to skin surveillance. Consumer questionnaires will examine intervention acceptability, the psychological impact, and attitudes towards melanoma risk and sun protective behaviour. Secondary outcomes include; the development of a holistic risk algorithm incorporating clinical, phenotypic and genetic factors to facilitate the identification of those most likely to benefit from this surveillance approach. In addition, the feasibility of integrating the intervention with teledermatology to enhance specialist care in remote locations will be evaluated. Conclusion This will be the first RCT to compare a targeted surveillance program utilising new 3D TBP technology against current routine clinical care for individuals at high risk of melanoma.
