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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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Stage 0\/I\/II melanoma patients (<jats:italic>n<\/jats:italic>\u2009=\u2009600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance,<jats:italic>n<\/jats:italic>\u2009=\u2009300) or control (usual care,<jats:italic>n<\/jats:italic>\u2009=\u2009300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (<jats:italic>n<\/jats:italic>\u2009=\u2009150) or non-polarised (<jats:italic>n<\/jats:italic>\u2009=\u2009150) 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\u2019s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician\u2019s usual practice.<\/jats:p><jats:p>The primary outcome, measured at 12\u00a0months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma 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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>Australian New Zealand Clinical Trials Registry (ANZCTR):<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.anzctr.org.au\/ACTRN12621000176864.aspx\">ACTRN12621000176864<\/jats:ext-link>. Registered on 18 February 2021.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-021-05231-7","type":"journal-article","created":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T20:03:06Z","timestamp":1620158586000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow-up? 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Any subsequent modifications will be submitted for review, and annual safety and progress reports will be presented. Informed consent will be obtained from all participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"No details or images relating to an individual person will be published. All data will be presented in aggregate form. A model consent form is available on request.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"HPS is a shareholder of MoleMap NZ Limited and e-derm consult GmbH and undertakes regular teledermatological reporting for both companies. HPS is a Medical Consultant for Canfield Scientific Inc., MetaOptima and Revenio Research Oy and a Medical Advisor for First Derm. PG receives a consultancy honorarium from MetaOptima. RPMS has received honoraria for advisory board participation from MSD, Novartis and Qbiotics and speaking honoraria from BMS. JFT has received honoraria for advisory board participation from BMS Australia, MSD Australia, GSK and Provectus Inc., and travel support from GSK and Provectus Inc. RAS has received fees for professional services from Qbiotics, Novartis, Merck Sharp & Dohme, NeraCare, AMGEN Inc., Bristol-Myers Squibb, Myriad Genetics, GlaxoSmithKline.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"324"}}