BACKGROUND: There are no universally accepted guidelines for the follow-up of individuals with cutaneous melanoma. Furthermore, to date, there have been no randomised controlled trials of different models of melanoma follow-up care. This randomised controlled trial was conducted to evaluate the effects of GP-led melanoma follow-up on patient satisfaction, follow-up guideline compliance, anxiety and depression, as well as health status. METHODS: A randomised controlled trial of GP-led follow-up of cutaneous melanoma was conducted over a period of 1 year with assessment by self-completed questionnaires and review of general practice-held medical records at baseline and 12 months later. It took place in 35 general practices in North-east Scotland. Subjects were 142 individuals (51.4% women 48.6% men; mean (s.d.) age 59.2 (15.2) years previously treated for cutaneous melanoma and free of recurrent disease. The intervention consisted of protocoldriven melanoma reviews in primary care, conducted by trained GPs and supported by centralised recall, rapid access pathway to secondary care and a patient information booklet. The main outcome measure was patient satisfaction measured by questionnaire. Secondary outcomes were adherence to guidelines, health status measured by Short Form-36 and the Hospital Anxiety and Depression Scale. RESULTS: There were significant improvements in 5 out of 15 aspects of patient satisfaction during the study year in those receiving GP-led melanoma follow-up (all Pp0.01). The intervention group was significantly more satisfied with 7 out of 15 aspects of care at follow-up after adjustment for potential confounders. There was significantly greater adherence to guidelines in the intervention group during the study year. There was no significant difference in health status or anxiety and depression between intervention and control groups at either baseline or outcome. CONCLUSIONS: GP-led follow-up is feasible, engenders greater satisfaction in those patients who receive it, permits closer adherence to guidelines and does not result in adverse effects on health status or anxiety and depression when compared with traditional hospital-based follow-up for melanoma.