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

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 ha...

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Bibliographic Details
Published in:	Current controlled trials in cardiovascular medicine 2021-05, Vol.22 (1), p.324-324, Article 324
Main Authors:	Ackermann, Deonna M, Smit, Amelia K, Janda, Monika, van Kemenade, Cathelijne H, Dieng, Mbathio, Morton, Rachael L, Turner, Robin M, Cust, Anne E, Irwig, Les, Hersch, Jolyn K, Guitera, Pascale, Soyer, H Peter, Mar, Victoria, Saw, Robyn P M, Low, Donald, Low, Cynthia, Drabarek, Dorothy, Espinoza, David, Emery, Jon, Murchie, Peter, Thompson, John F, Scolyer, Richard A, Azzi, Anthony, Lilleyman, Alister, Bell, Katy J L
Format:	Article
Language:	eng
Subjects:	Cancer Cancer surveillance Clinical trials Coronaviruses Corporate sponsorship Cost control Dermatology Early detection of cancer Health care expenditures Health sciences Hospitals Medical prognosis Medical research Melanoma Mortality Patients Preventive medicine Public health Self-examination Smartphones Study Protocol Teledermoscopy Telehealth Telemedicine
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Summary:	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. 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 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). 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 soci
ISSN:	1745-6215 1745-6215 1468-6694