Characteristics of Participants Screened and Randomized to the Melanoma Self Surveillance Trial

Abstract

Importance: The MEL-SELF randomized clinical trial (RCT) evaluated patient-led surveillance as an alternative model of follow-up. The baseline characteristics of participants provide insights into current unmet clinical needs of this population. Objective: To describe the baseline characteristics of people screened for and randomized to the MEL-SELF RCT, and those potentially eligible but not randomized. Design, Setting, and Participants: Baseline data from the RCT's recruitment processes, from December 2021 to June 2024, were analyzed. Data were collected from dermatologist- and general practitioner-led skin cancer clinics in Australia, and included adults previously treated for early-stage melanoma (by American Joint Committee on Cancer Staging Manual [AJCC, 0-II]) attending routinely scheduled clinics, with a skin self-examination (SSE) partner, and a smartphone. Analysis took place between August 2025 and December 2025. Interventions: Participants were invited to participate in the MEL-SELF trial with randomization (1:1) to patient-led surveillance (usual care plus reminders to perform SSE, mobile dermatoscope, teledermatologist assessment, fast-tracked unscheduled clinic visits) or clinician-led surveillance (usual care) for 12 months. Main Outcomes and Measures: The main outcomes were enrollment; active run-in and allocation results, sociodemographic and clinical characteristics; SSE knowledge, attitudes, and practice (frequency and thoroughness); and psychological measures including fear of cancer recurrence (FCR) at baseline. Results: Of 1226 patients screened and potentially eligible, 504 were randomized to patient-led (n = 251) or clinician-led (n = 253) surveillance. Overall, 295 were female individuals (59%) and 209 were male individuals (41%), most were aged 50 years and older (mean [SD] age, 56.0 [11.6] years) and had a highest substage of melanoma in situ (245 [49%]) or IA (217 [43%]). SSE practice varied substantially, ranging from no SSE in the previous 12 months (103 [20%]) to weekly or monthly SSE (160 [32%]). A high proportion (232 [46%]) reported clinically significant levels of FCR, which was associated with being female, younger age, and higher depression, anxiety, and stress scores. FCR was associated with a higher perceived lifetime risk of melanoma, but not with participants' actual calculated risk of a subsequent new primary melanoma (OR, 1.00; 95% CI, 0.99-1.01). Characteristics were similar between the trial population and potentially eligible patients who completed the baseline questionnaire but were not randomized (n = 225). Conclusions: This secondary analysis of baseline characteristics in the MEL-SELF trial indicates suboptimal SSE practice and clinically significant levels of FCR. Future reports will evaluate comparative effects of patient-led surveillance on health, psychological and health resource use outcomes. Trial Registration: anzctr.org.au Identifier: ACTRN12621000176864.