MEL-SELF: a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance in people treated for localised melanoma.

Before randomisation, all potential participants undergo an active run-in phase. In the active run-in phase participants will be asked to: • complete an online Baseline Questionnaire measuring demographics, knowledge, attitudes and confidence on self-examination and smartphone applications, and their baseline level of fear of new or recurrent melanoma (using a melanoma specific version of the Fear of Cancer Recurrence Index) • log-in to the web-based ASICA skin checker platform, view instructional videos, and undertake guided total skin self-examination and electronic reporting of their findings • upload a macroscopic digital photo, using their smartphone, of a predetermined target lesion and a photo of their back (to document sun damage) to the study’s web-based platform (in REDCap). The active run-in phase will occur approximately one week prior to randomisation and participants who successfully complete all activities will continue in the trial. Intervention details The intervention arm will receive the intervention (patient-led surveillance) as an adjunct to usual care (clinician-led surveillance) for 12 months from the date of randomisation. They receive clinician-led surveillance: • An educational booklet ‘Your guide to early melanoma’ (freely available at https://www.melanoma.org.au/melanoma/assets/File/Stage%20I%20and%20II%20(Early%20Stage)%20Melanoma%20Information%20Packs_FINAL.pdf) • Routinely scheduled visits as per treating clinician. • Unscheduled (short notice) visits as needed through usual referral pathways (e.g. local general practitioner). In addition, they receive patient-led surveillance: • Continued access to web-based ASICA skin checker instructional videos as described in Murchie P, Allan JL, Brant W, et al: Total skin self-examination at home for people treated for cutaneous melanoma: development and pilot of a digital intervention. BMJ Open 5:e007993, 2015. • A mobile dermatoscope to attach to their phone, with random allocation to either low cost (non-polarised light source) or higher cost device (polarised light source). Detailed written and video instructions on how to use the dermatoscope and accompanying smartphone app (readily available to anyone who purchases the device – i.e. not study specific). • One-to-one training for the participant and their partner on how to use the dermatoscope and accompanying app, delivered by web conferencing. The frequency and duration of training will be tailored to the participants needs and preferences • Email or SMS text (dependent on participant preference) reminders every 3 months to perform skin self-examination. • Teledermatology: Participants take dermoscopic images of a “target” lesion determined by their treating clinician and up to 8 additional lesions of concern. These images are submitted through the dermatoscope smartphone app and transmitted to one of the study teledermatologists who will undertake review within 3 working days. The results are reported to the participant and study personnel. • A fast-tracked unscheduled clinic visit is facilitated by study staff if recommended by the teledermatologist. Adherence will be measured through self-report in questionnaires at baseline, 6 and 12 months and through the submission of a minimum of one and a maximum of eight images at the end of each three-month cycle. In addition, a nested qualitative study will be conducted to understand patients’ and clinicians’ acceptability and satisfaction with the intervention and explore components which may need to be changed for implementation into routine clinical practice. A sub-set of participants from both study arms and all clinicians of intervention arm patients will be approached and invited to take part in semi structured telephone interviews. Up to 45 semi-structured interviews will be held with patients, and up to 10 semi-structured interviews will be held with clinicians. We will invite participants who indicated their interest in taking part in the interviews. We will use purposive sampling of participants who opt-in to this additional interview component to maximise diversity of experience. We anticipate recruiting 30-45 participants for the nested qualitative study, a sample size commonly sufficient to reach saturation in themes and topics.