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.

Primiero, Claire Amy and McInerney-Leo, Aideen M. and Betz-Stablein, Brigid and Whiteman, David C. and Gordon, Louisa and Caffery, Liam and Aitken, Joanne F. and Eakin, Elizabeth and Osborne, Sonya and Gray, Len and Smithers, B. Mark and Janda, Monika and Soyer, H. Peter and Finnane, Anna (2019) 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. BMJ Open, 9 (11). pp. 1-9.

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Abstract

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.


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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Nursing and Midwifery (1 Jan 2015 -)
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Nursing and Midwifery (1 Jan 2015 -)
Date Deposited: 22 Jan 2020 01:44
Last Modified: 29 Jan 2020 02:52
Uncontrolled Keywords: early detection; melanoma; RCT; total-body photography
Fields of Research : 11 Medical and Health Sciences > 1199 Other Medical and Health Sciences > 119999 Medical and Health Sciences not elsewhere classified
Socio-Economic Objective: E Expanding Knowledge > 97 Expanding Knowledge > 970111 Expanding Knowledge in the Medical and Health Sciences
Funding Details:
Identification Number or DOI: DOI: 10.1136/bmjopen-2019-032969
URI: http://eprints.usq.edu.au/id/eprint/37339

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