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 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 on 18 February 2021.

Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF)

“…We are collecting more detailed information on recruitment processes in a larger ongoing trial of the same intervention. 39 The increased detection of melanoma observed in the intervention group raises the possibility of overdiagnosis, that is, the detection of indolent lesions that would not cause harm if left untreated. 40,41 Melanoma overdiagnosis may produce substantial financial and opportunity costs to the health care system, 4,10,42 as well as psychological distress.…”

“…[46][47][48] The difficulties that were encountered have provided important information for refining the design and conduct of a larger ongoing RCT of patient-led surveillance. 39 Improvements to address the patient burden include the introduction of an active run-in phase prior to randomization to ensure participants are able to adhere to the protocol and use of a "target lesion" (chosen by the treating physician) that the patient will monitor via teledermoscopy along with any other suggestive lesions they identify. We are providing more 1-on-1 training on the intervention technologies to patients, and we are training the skin-check partners as well.…”

“…The larger ongoing RCT of patient-led surveillance aims to assess comparative effects on health, psychological, and resource use outcomes in patients with localized melanoma. 39 If the intervention is found to be beneficial, it may then be tested in other clinical populations at higher risk of new primary or recurrent melanoma, including patients with stage III disease 12,53 and organ transplant recipients. 54 This evidence may transform melanoma surveillance models of care for diverse patient populations.…”

Exploring the Integration of Environmental Impacts in the Cost Analysis of the Pilot MEL-SELF Trial of Patient-Led Melanoma Surveillance

“…This prevented any meaningful comparison between randomised groups, and any notional difference in costs or impacts should not be interpreted as a true difference between the study groups. We have improved data collection processes in a larger RCT of the same MEL-SELF intervention that is underway, including use of a digital diary to measure health resource use [ 32 ]. Second, the current study is limited in scope, particularly for the environmental impact estimates, which were limited to patient transport to treating melanoma clinic appointments only and did not include travel for other clinics or healthcare use, nor emissions related to the manufacture and use of the mobile dermatoscope, or the delivery of healthcare services.…”

Perspectives and Experiences of Patient-Led Melanoma Surveillance Using Digital Technologies From Clinicians Involved in the MEL-SELF Pilot Randomized Controlled Trial: Qualitative Interview Study

“…Commercial teledermatology services offer a store-and-forward modality of teledermatology as part of remote service delivery models where there is no prior patient-doctor relationship and without referral [14][15][16][17]. More recently, store-and-forward teledermoscopy has become available in clinical trial settings, whereby patients take dermoscopic images of concerning lesions using a mobile dermatoscope attached to their smartphone camera and transmit these securely to a dermatologist via a smartphone app [18][19][20][21]. If shown to be safe, cost-effective, and acceptable to patients, acceptance by teledermatologists assessing images and by treating doctors is also needed before this new model of care is adopted into routine practice [7,22].…”