Skin self-examinations (SSEs) for the detection of primary or recurrent melanomas may be an effective surveillance strategy. The protocol design for a randomized, controlled trial to assess such a program was published in Trials.
Clinician-led surveillance for melanomas is a resource-intensive strategy with little evidence of improved health outcomes. The MEL-SELF trial was designed with the primary objective of assessing the efficacy of a self-led melanoma screening program and secondary objectives of psychological outcomes, adherence to skin self-examination, acceptability, cost, and resource management.
Patients with stage 0/I/II melanomas will be recruited from clinics in New South Wales in Australia with a goal sample size of 600 patients. Participants will be randomly assigned in a 1:1 ratio to undergo usual care or the self-led surveillance.
All patients will receive an educational booklet entitled Managing Melanoma Risk. Participants in the usual care group will have routinely scheduled clinic visits according to each clinician’s usual practice.
Those assigned to the intervention cohort will receive SSE instructional videos and email reminders to perform SSE every 3 months for 12 months. They also will receive a polarized dermatoscope device or a nonpolarized dermatoscope device, given in a random 1:1 ratio, for patient-performed dermoscopy. Patients will receive feedback about their teledermoscopy data from their dermatologist within 72 hours, with fast-tracked unscheduled clinic visits as well as regularly scheduled visits, based on the teledermatologist report, where applicable.
At 12 months, all new and recurrent melanomas diagnosed will be assessed as well as all secondary endpoints. At 24 months, clinical outcomes from patients who develop skin cancer as well as total program costs will be evaluated. Patient and clinician opinions about the self-examination program will be elucidated via an interview conducted by telephone.
Patient recruitment is set to begin in July 2021, and the trial is projected to be completed in June 2023.
These study results may inform evidence-based follow-up care guidelines that are cost-effective and improve early detection of subsequent new primary or recurrent melanoma.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Ackermann DM, Smit AK, Janda M, et al. 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. Trials. 2021;22(1):324. doi:10.1186/s13063-021-05231-7