A Randomised Patient-Focused Trial of the Achieving Self-Directed Integrated Cancer Aftercare (ASICA) Intervention for Detection of Recurrent and Second Primary Melanoma: Effect on Psychological Well-Being and Quality of Life

Background: Melanoma is common and incidence is increasing. UK guidelines recommend monthly Total-Skin-Self-Examination (TSSE) performed by melanoma survivors to detect recurrent and new primary melanoma. TSSE is underperformed despite evidence of benefit. ASICA (Achieving Self-directed Integrated Cancer Aftercare) is a tablet-based digital intervention to prompt and support TSSE in melanoma survivors.       Methods: Adults diagnosed with 0-IIC primary cutaneous melanoma from two UK NHS hospitals (Grampian and Cambridge) were recruited and randomised (1:1) to ASICA or control. Data on co-primary outcomes: melanoma worry (Melanoma Worry Scale, MWS), anxiety and depression (Hospital Anxiety and Depression Scale; HADs),  and quality of life (EuroQoL EQ-5D-5L) were collected by postal questionnaire 3, 6 and 12-months following randomisation.  Findings: Recruits were randomised (1:1) to ASICA (n=141) or control, n=140). There were no significant differences between groups for melanoma worry at 12 months (mean difference 0⸱12 95% confidence interval (-0⸱6, 0⸱84), p=0⸱743), at 3 months (0⸱23 (-0⸱31, 0⸱78) p=0.402) or 6 months (-0⸱1 (-0⸱7, 0⸱51) p=0⸱757). The ASICA group had lower anxiety scores at 12 months (-0.54 (-1.31, 0.230 p=0.168), at 3 months (-0⸱13; -0⸱.79, 0⸱54; p=0⸱711) and significantly at 6 months  (-1⸱00 (-1⸱74, -0⸱26) p=0⸱009). Depression scores were similar being lower at 12 months (-0⸱44 (-1⸱11, 0⸱23), p=0.195) and 3 months (-0⸱24 (-0⸱84, 0⸱35)p=0⸱421) but only significantly lower at 6 months (-0⸱77 (-1⸱41, -0⸱12) p=0⸱020). The ASICA group had significantly higher quality of life scores at 12 months (0⸱044; (0⸱003, 0⸱085); p=0⸱036) and 6 months (0⸱070 (0⸱032, 0⸱107) p<0⸱001) and non-signifcantly at 3 months 0⸱024(-0⸱006, 0⸱054) p=0⸱112).  Interpretation: Using ASICA for 12 months does not increase melanoma worry, and can reduce anxiety and depression and improves quality of life. ASICA has the potential to improve well-being of melanoma survivors and enable the benefits of regular TSSE.   Trial Registration: Clinical Trials.gov:Trial registration number NCT03328247. Funding: Cancer Research UK (Project Number funded the work C10673/A21685). Declaration of Interest: No authors have any competing interests to declare. Ethical Approval: This project received full approval from the North of Scotland Research Ethics Committee on 28th April 2017 ((17/NS/0040).