Supporting Melanoma Survivors with Digital Healthcare - a Randomized Clinical Trial of the ASICA Intervention

Context: 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.

Study design: Randomized clinical trial.

Setting: Two UK NHS hospitals (Aberdeen Royal Infirmary, Grampian and Addenbrookes, Cambridge

Population studied: Adults (aged ≥18) diagnosed with a first 0-IIC primary cutaneous melanoma.

Intervention: ASICA (Achieving Self-directed Integrated Cancer Aftercare) is a tablet-based digital intervention to prompt and support TSSE in melanoma survivors. 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.

Outcomes Measures: 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<0·001) and non-signifcantly at 3 months 0·024(-0·006, 0·054) p=0·112).

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.