MEL-SELF dataset: a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance in people treated for localised melanoma

Abstract

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. Stage 0/I/II melanoma patients (n=500) from dermatology, surgical, or general practice clinics in Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n=250) or control (usual care, n=250). 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. Clinical secondary outcomes include time from randomisation to diagnosis of any skin cancer (melanoma or keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), number of lesions surgically evaluated, and number of clinic visits attended. Patient-reported outcomes collected at baseline, 6 and 12 months, include thoroughness, confidence, beliefs, and knowledge of skin self-examination, adherence with recommended clinician SSE practice guidelines, fear of new or recurrent melanoma severity and general anxiety, stress, and depression. A nested qualitative study will include interviews with patients and clinicians, and a costing study will compare costs from a societal perspective. The data will be available in CSV format.