BACKGROUND: Melanoma is common with increasing incidence. Guidelines recommend monthly total skin self-examinations (TSSEs) by survivors to detect recurrent and new primary melanomas. TSSE is underperformed despite evidence of benefit.
OBJECTIVE: This study compares the effect on psychological well-being and TSSE practice of a self-directed digital intervention with treatment as usual in patients treated for a first stage 0 to IIC primary cutaneous melanoma within the preceding 60 months.
METHODS: This randomized clinical trial was conducted at 2 UK National Health Service hospitals (Aberdeen Royal Infirmary, Grampian, and Addenbrooke's, Cambridge). Adults (≥18 years) diagnosed with a first 0 to IIC primary cutaneous melanoma were randomized to receive Achieving Self-directed Integrated Cancer Aftercare (ASICA), a tablet-based intervention prompting and supporting TSSE in survivors of melanoma, or to usual care. The hypothesis was that ASICA would increase TSSE practice in users affected by melanoma and compared with controls without affecting psychological well-being. The main primary outcomes were melanoma worry (Melanoma Worry Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and quality of life (EQ-5D-5L) as well as secondary outcomes collected using postal questionnaires 3, 6, and 12 months following randomization.
RESULTS: A total of 240 recruits were randomized (1:1) into the ASICA (n=121, 50.4%) or control (n=119, 49.6%) groups. There were no significant differences between groups for melanoma worry at 12 months (mean difference: 0.12, 95% CI -0.6 to 0.84; P=.74), 3 months (0.23, 95% CI -0.31 to 0.78; P=.40), or 6 months (-0.1, 95% CI -0.7 to 0.51; P=.76). The ASICA group had lower anxiety scores at 12 months (-0.54, 95% CI -1.31 to 0.230; P=.17), 3 months (-0.13, 95% CI -0.79 to 0.54; P=.71), and significantly at 6 months (-1.00, 95% CI -1.74 to -0.26; P=.009). Depression scores were similar, being lower at 12 months (-0.44, 95% CI -1.11 to 0.23; P=.20) and 3 months (-0.24, 95% CI -0.84 to 0.35; P=.42) but only significantly lower at 6 months (-0.77, 95% CI -1.41 to -0.12; P=.02). The ASICA group had significantly higher quality of life scores at 12 months (0.044, 95% CI 0.003-0.085; P=.04) and 6 months (0.070, 95% CI 0.032-0.107; P<.001) and nonsignificantly at 3 months (0.024, 95% CI -0.006 to 0.054; P=.11). ASICA users reported significantly more regular (>5) TSSEs during the study year and significantly higher levels of self-efficacy in conducting TSSE. They also reported significantly higher levels of planning and intention to perform TSSE in the future.
CONCLUSIONS: Using ASICA for 12 months does not increase melanoma worry, can reduce anxiety and depression, and may improve quality of life. ASICA has the potential to improve the well-being and vigilance of survivors of melanoma and enable the benefits of regular TSSE.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3453-x.
The authors gratefully acknowledge Joanna Kaniewska, Anne Duncan, and Alison MacDonald (trial management) for their contributions to the protocol and management of the study and Andrea Fraser for secretarial support and data coordination. They also acknowledge Bolanle Birkinns and Susie Hall, who were the research nurses who trained participants and collected case note data at the Aberdeen and Cambridge sites, respectively. The authors thank Mr Mark Forrest and Mr Michael Chung for supporting the digital aspects of the intervention and data collection. They also thank Ms Ilja De Vries and her team from Medical Illustration for providing digital skin maps at the Aberdeen site and Mr Mark Bartley and the Medical Photography team at Addenbrooke’s Media Studio for providing skin maps for the Cambridge participants. The authors also thank Dr Aileen Neilson, who provided advice on collecting data about service use. They also wish to acknowledge the contribution of Rebecca Woods, Patricia Fairbrother, and Dr Doug Smith, who were members of the trial steering committee. The authors also acknowledge the 19 people affected by melanoma who participated in their early feasibility study. This study was supported by a grant from a Cancer Research UK Population Research Committee project award (C10673/A21685). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of Cancer Research UK. The funder (through their peer review and funding board review process) approved the study proposal but had no role in the collection, analysis, or interpretation of the data; the writing of the report; or the decision to submit this paper for publication. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates.
- primary care
- randomized controlled trial
- seld-directed care