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Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial.

Authors
  • Ackermann, Deonna M1
  • Dieng, Mbathio2
  • Medcalf, Ellie1
  • Jenkins, Marisa C1
  • van Kemenade, Cathelijne H1
  • Janda, Monika3
  • Turner, Robin M4
  • Cust, Anne E1, 5, 6
  • Morton, Rachael L2
  • Irwig, Les1
  • Guitera, Pascale5, 7, 8
  • Soyer, H Peter9
  • Mar, Victoria10
  • Hersch, Jolyn K1
  • Low, Donald11
  • Low, Cynthia11
  • Saw, Robyn P M5, 8
  • Scolyer, Richard A5, 7, 8, 12, 13
  • Drabarek, Dorothy1
  • Espinoza, David2
  • And 6 more
  • 1 School of Public Health, The University of Sydney, Sydney, New South Wales, Australia. , (Australia)
  • 2 National Health and Medical Research Council (NHMRC) Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia. , (Australia)
  • 3 Centre for Health Services Research, The University of Queensland, Brisbane, Queensland, Australia. , (Australia)
  • 4 Biostatistics Centre, University of Otago, Dunedin, Otago, New Zealand. , (New Zealand)
  • 5 Melanoma Institute Australia, The University of Sydney, Sydney, New South Wales, Australia. , (Australia)
  • 6 The Daffodil Centre, The University of Sydney, Sydney, New South Wales, Australia. , (Australia)
  • 7 Royal Prince Alfred Hospital, Sydney, New South Wales, Australia. , (Australia)
  • 8 Faculty of Medicine and Health, Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia. , (Australia)
  • 9 Dermatology Research Centre, The University of Queensland Diamantina Institute, The University of Queensland, Brisbane, Australia. , (Australia)
  • 10 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia. , (Australia)
  • 11 Cancer Voices New South Wales, Sydney, New South Wales, Australia. , (Australia)
  • 12 New South Wales Health Pathology, Sydney, New South Wales, Australia. , (Australia)
  • 13 Charles Perkins Centre, The University of Sydney, Sydney, New South Wales, Australia. , (Australia)
  • 14 Newcastle Skin Check, Newcastle, New South Wales, Australia. , (Australia)
  • 15 Academic Primary Care Research Group, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, Scotland, United Kingdom. , (United Kingdom)
Type
Published Article
Journal
JAMA dermatology
Publication Date
Jan 01, 2022
Volume
158
Issue
1
Pages
33–42
Identifiers
DOI: 10.1001/jamadermatol.2021.4704
PMID: 34817543
Source
Medline
Language
English
License
Unknown

Abstract

Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma. To determine whether patient-led surveillance in patients with prior localized primary cutaneous melanoma is as safe, feasible, and acceptable as clinician-led surveillance. This was a pilot for a randomized clinical trial at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia. The participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits. The study was conducted from November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020. Participants were randomized (1:1) to 6 months of patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care). The primary outcome was the proportion of eligible and contacted patients who were randomized. Secondary outcomes included patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma). Of 326 patients who were eligible and contacted, 100 (31%) patients (mean [SD] age, 58.7 [12.0] years; 53 [53%] men) were randomized to patient-led (n = 49) or clinician-led (n = 51) surveillance. 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 was associated with increased SSE frequency (odds ratio [OR], 3.5; 95% CI, 0.9 to 14.0) and thoroughness (OR, 2.2; 95% CI, 0.8 to 5.7), had no detectable adverse effect on psychological outcomes (fear of cancer recurrence subscale score; mean difference, -1.3; 95% CI, -3.1 to 0.5), and increased clinic visits (risk ratio [RR], 1.5; 95% CI, 1.1 to 2.1), skin lesion excisions (RR, 1.1; 95% CI, 0.6 to 2.0), and subsequent melanoma diagnoses and subsequent melanoma diagnoses (risk difference, 10%; 95% CI, -2% to 23%). New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%). This pilot of a randomized clinical trial found that patient-led surveillance after treatment of localized melanoma appears to be safe, feasible, and acceptable. Experiences from this pilot study have prompted improvements to the trial processes for the larger trial of the same intervention. http://anzctr.org.au Identifier: ACTRN12616001716459.

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