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

Trials

Robin M. Turner¹  Anne E. Cust²  Amelia K. Smit²  Donald Low³  Cynthia Low³  Jon Emery⁴  Monika Janda⁵  H. Peter Soyer⁶  Peter Murchie⁷  Robyn P. M. Saw⁸  John F. Thompson⁸  Pascale Guitera⁹  Richard A. Scolyer^1,10  Rachael L. Morton^1,11  Mbathio Dieng^1,12  David Espinoza^1,12  Anthony Azzi^1,13  Alister Lilleyman^1,13  Deonna M. Ackermann^1,14  Katy J. L. Bell^1,14  Dorothy Drabarek^1,14  Jolyn K. Hersch^1,14  Cathelijne H. van Kemenade^1,14  Les Irwig^1,14  Victoria Mar^1,15 

[1] Biostatistics Centre, University of Otago, Dunedin, New Zealand;Cancer Epidemiology and Prevention Research, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia;Melanoma Institute Australia, The University of Sydney, Sydney, Australia;Cancer Voices NSW, Sydney, Australia;Centre for Cancer Research, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia;Centre for Health Services Research, The University of Queensland, Brisbane, Australia;Dermatology Research Centre, The University of Queensland Diamantina Institute, The University of Queensland, Brisbane, Australia;Department of Dermatology, Princess Alexandra Hospital, Brisbane, Australia;Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, United Kingdom;Melanoma Institute Australia, The University of Sydney, Sydney, Australia;Faculty of Medicine and Health, The University of Sydney, Sydney, Australia;Division of Surgery, Royal Prince Alfred Hospital, Sydney, Australia;Melanoma Institute Australia, The University of Sydney, Sydney, Australia;Faculty of Medicine and Health, The University of Sydney, Sydney, Australia;Sydney Melanoma Diagnostic Centre, Royal Prince Alfred Hospital, Sydney, Australia;Melanoma Institute Australia, The University of Sydney, Sydney, Australia;Faculty of Medicine and Health, The University of Sydney, Sydney, Australia;Tissue Pathology and Diagnostic Oncology, Royal Prince Alfred Hospital and NSW Health Pathology, Sydney, Australia;Melanoma Institute Australia, The University of Sydney, Sydney, Australia;NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia;NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia;Newcastle Skin Check, Newcastle, Australia;Faculty of Medicine, University of Queensland, Brisbane, Australia;Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia;Victorian Melanoma Service, Alfred Health, Melbourne, Australia;School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia;

关键词: Melanoma;    Cancer surveillance;    Early detection of cancer;    Self-examination;    Teledermoscopy;    Telehealth;    Randomised controlled trial;    Health services research;   

DOI  :  10.1186/s13063-021-05231-7

来源: Springer

【 摘 要 】

BackgroundMost 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.MethodsStage 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).DiscussionThe 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 registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered on 18 February 2021.

【 授权许可】

CC BY