Redesigning Skin Cancer Early Detection and Care Using a New Mobile Health Application: Protocol of the SKIN Research Project, a Randomised Controlled Trial

Abstract

Patients often detect melanoma themselves; therefore, regular skin self-examinations (SSEs) play an important role in the early detection and prompt treatment of melanoma. Mobile teledermoscopy is a technology that may facilitate consumer SSEs and rapid communication with a dermatologist. This paper describes the planned randomised controlled trial of an intervention to determine whether mobile technologies can help improve the precision of SSE in consumers. A randomised controlled trial will be conducted to evaluate mobile teledermoscopy-enhanced SSE versus naked-eye SSE. Participants in each group will conduct three home whole-body SSEs at baseline, 1 and 2 months, then present for a clinical skin examination (CSE) by a doctor after the 2-month SSE. Specifically, participants will identify skin lesions that meet the AC (asymmetry and colour) rule for detecting a suspicious skin spot. The primary outcomes are sensitivity and specificity of the skin lesions selected by the participants as needing attention by a doctor, compared to the clinical diagnosis by the dermatologist that will serve as the reference standard for this analysis. For the mobile teledermoscopy-enhanced SSE group, researchers will assess the number, location and type of lesions (1) sent by the participant via mobile teledermoscopy, (2) found at CSE or (3) missed by the participant. For the naked-eye SSE group, researchers will assess the number, location and type of lesions (1) recorded on their body chart by the participant, (2) found at CSE or (3) missed by the participant. Secondary outcomes are based on participants’ self-reported data via online questionnaires.