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