Objective To determine whether patient-led surveillance compared with clinician-led surveillance in patients with prior localized primary cutaneous melanoma is safe, feasible and acceptable.
Design Randomized controlled trial.
Setting Two specialist-led clinics in metropolitan Sydney and a primary care skin cancer clinic run by general practitioners in metropolitan Newcastle.
Participants 100 patients previously treated for localized melanoma, who owned a
smartphone, had a partner to assist with skin self-examination (SSE), and were attending routinely scheduled follow-up.
Intervention Participants were randomized (1:1) to six months of patient-led surveillance (intervention: usual care plus reminders to perform SSE, patient performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (control: usual care).
Main outcomes and measures The primary outcome was the proportion of eligible
18 and contacted patients who were randomized. Secondary outcomes included
patient-reported outcomes (SSE knowledge, attitudes and practice, psychological outcomes, other healthcare use) and clinical outcomes (clinic visits, skin surgeries, subsequent new primary or recurrent melanoma).
Between November 2018 and May 2019, 326 patients were found to be
eligible and contacted, and 100 (31%; 95%CI:26% to 36%) were randomized to patient-led surveillance (n=49) or clinician-led surveillance (n=51). Data were available on patient-reported outcomes for 66 participants, and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance increased SSE frequency and thoroughness, had no detectable effect on psychological outcomes, but did increase clinic visits, skin lesion excisions, and subsequent new primary melanoma diagnoses. New primary melanomas and one local recurrence were diagnosed in 8 intervention group participants (16%) including 5 at unscheduled visits (10%), and 3 control group participants (6%), with none at unscheduled visits (0%) (between-group difference: 10%; 95%CI: 2% to 19%).
Conclusion Patient-led surveillance following treatment of localized melanoma appears safe, feasible and acceptable. Difficulties that some participants experienced with adherence, response to questionnaires, and retention in the trial, as well the potential of the intervention to cause medical overuse, have prompted changes to trial processes for a larger trial of the same intervention.