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

This research project is funded by a National Health and Medical Research Council (NHMRC) Project grant (#1163054). The funder had no role in the design of the study and will have no role in the collection, analysis, and interpretation of the data; the writing of the report; or the decision to submit the report for publication. Funding Information: AEC is funded by a Career Development Fellowship from the National Health and Medical Research Council (NHMRC; 1147843). JFT is a recipient of an NHMRC Program Grant (1093017). RPMS is supported by Melanoma Institute Australia. RAS is supported by a NHMRC Program Grant and Practitioner Fellowship. For RAS, support from the from colleagues at Melanoma Institute Australia, Royal Prince Alfred Hospital and NSW Health Pathology is also gratefully acknowledged. RLM is supported with an NHMRC Investigator grant (1194703) and a University of Sydney Robinson Fellowship. HPS holds an NHMRC MRFF Next Generation Clinical Researchers Program Practitioner Fellowship (APP1137127). JH is supported by an NHMRC Early Career Fellowship (1112509). KB is supported by an NHMRC Investigator Grant (1174523) and a University of Sydney Research Accelerator (SOAR) Prize.Peer reviewedPublisher PD

Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF) A Pilot Randomized Clinical Trial

Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma. Objective To determine whether patient-led surveillance in patients with prior localized primary cutaneous melanoma is as safe, feasible, and acceptable as clinician-led surveillance. Design, Setting, and Participants This was a pilot for a randomized clinical trial at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia. The participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits. The study was conducted from November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020. Intervention Participants were randomized (1:1) to 6 months of patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care). Main Outcomes and Measures The primary outcome was the proportion of eligible and contacted patients who were randomized. Secondary outcomes included patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma)