The Achieving Self-Directed Integrated Cancer Aftercare (ASICA) intervention for detection of recurrent and second primary melanoma: a randomized pilot trial (Preprint)

BACKGROUND Melanoma is common and incidence increasing. 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. OBJECTIVE To compare a self-directed digital intervention (intervention group) with treatment as usual (control group) in patients treated for a first stage 0-IIC primary cutaneous melanoma within the preceding 60 months. METHODS This randomized clinical trial was conducted at two UK NHS hospitals (Aberdeen Royal Infirmary, Grampian and Addenbrookes, Cambridge). Adults (aged ≥18) diagnosed with a first 0-IIC primary cutaneous melanoma were randomised to receive ASICA (Achieving Self-directed Integrated Cancer Aftercare) a tablet-based digital intervention to prompt and support TSSE in melanoma survivors, or to usual care. The hypothesis tested was that ASICA would increase TSSE practice in those affected by melanoma using it, and compared to controls, without affecting psychological well-being. The main 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. RESULTS 241 recruits 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 CONCLUSIONS 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. CLINICALTRIAL Clinical Trials.gov:Trial registration number NCT03328247. Registered 01 November 2017, https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1. First participant randomised on 25 January 2018. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-019-3453-x