Employing skin self-examination and fear of cancer recurrence management in early-stage melanoma follow-up: evaluation of the MELACARE intervention in a randomised controlled trial

PurposeThe MELACARE intervention aimed to evaluate a nurse-led follow-up program incorporating skin self-examination (SSE) education and psychosocial support to address fear of cancer recurrence (FCR) in early-stage melanoma survivors. This study assessed the MELACARE intervention's impact on FCR, psychological well-being, SSE performance, and healthcare usage compared to standard physician-led follow-up.MethodsA two-group randomised controlled trial was conducted at Herlev and Gentofte Hospital, Denmark. Participants included 153 patients with surgically treated melanoma (stages IA-IIA). Patients were randomised to either the MELACARE intervention (n = 78) or a control group provided treatment as usual (n = 75). The intervention involved nurse-led sessions focusing on SSE techniques and metacognitive strategies. Outcomes included FCR (primary), distress, anxiety, depression, health-related quality of life (HRQoL), patient activation, and SSE frequency and confidence (secondary) at 6 months. Trial registration: ClinicalTrials.gov (NCT05253872).ResultsAt 6 months, the mean of the primary outcome FCR was lower in the intervention compared to the control groups, but the difference was not statistically significant (- 0.86 [- 3.34;1.62]). Intervention patients reported higher HRQoL (18% [3;32]) and patient activation (0.43 [0.15;0.71]) as the only significant secondary outcomes. Confidence in SSE was higher in the intervention group, with most performing SSE at recommended intervals.ConclusionsThe MELACARE intervention may improve HRQoL and patient activation but did not reduce FCR. High fidelity of delivery and patient adherence highlight its potential utility.Implications for Cancer SurvivorsThe MELACARE approach empowers melanoma survivors through structured SSE education and psychosocial support. Future analyses will investigate long-term safety and efficacy.