Can Patient-Led Surveillance Detect Subsequent New Primary or Recurrent Melanomas and Reduce the Need for Routinely Scheduled Follow Up? A Protocol for the MEL-SELF Randomised Controlled Trial.

Abstract

Background: Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma. Methods: Stage 0/I/II melanoma patients (n=600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n=300) or control (usual care, n=300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n=150) or non-polarised (n=150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician’s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician’s usual practice. The primary outcome, measured at 12-months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma diagnosed at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised).Discussion: The findings from this study may inform guidance on evidence-based follow up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society.Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered 18 February 2021, https://www.anzctr.org.au/ACTRN12621000176864.aspx

Exploring the Integration of Environmental Impacts in the Cost Analysis of the Pilot MEL-SELF Trial of Patient-Led Melanoma Surveillance

“…This prevented any meaningful comparison between randomised groups, and any notional difference in costs or impacts should not be interpreted as a true difference between the study groups. We have improved data collection processes in a larger RCT of the same MEL-SELF intervention that is underway, including use of a digital diary to measure health resource use [32]. Second, the current study is limited in scope, particularly for the environmental impact estimates, which were limited to patient transport to treating melanoma clinic appointments only and did not include travel for other clinics or healthcare use, nor emissions related to the manufacture and use of the mobile dermatoscope, or the delivery of healthcare services.…”

Early detection of skin cancer in Australia – current approaches and new opportunities

“…• Improvements in skin cancer risk-prediction tools by incorporating imaging data of dermoscopic and phenotypic features, and genomic data • Evaluation of advanced digital diagnostic technologies and artificial intelligence, in the clinic and by consumers • Identifying clinical, dermoscopic and molecular features of indolent and aggressive melanomas and other skin cancers impact of mobile teledermoscopy in melanoma patient follow-up care and whether the technology may assist with melanoma diagnosis between routinely scheduled in-person care. 37 Previous research has found that patients identify up to 40% of melanoma recurrences 38 , and this technology may further assist with a more rapid diagnosis. Moving to patient-led surveillance would require improvement of SSE education and practice, which is currently suboptimal in the general population, with studies suggesting that few people carry out SSE thoroughly.…”