Abstract
Background: Melanoma is common, 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased five-fold in 30 years. Melanoma affects old and young people with poor prognosis once metastatic. UK guidelines recommends people treated for cutaneous melanoma receive extended outpatient hospital follow-up to detect recurrence or new primaries. Such follow-up to the growing population of melanoma survivors is burdensome for both individuals and health services. Follow-up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4-8% develop a new primary, the risk of both is highest in the first five years. ASICA (Achieving Self-directed Integrated Cancer Aftercare) is a digital intervention to increase Total-Skin-Self-Examination (TSSE) by people treated for melanoma, with usual follow-up.
Methods: We aim to recruit 240 adults with a previous first stage 0-2C primary cutaneous melanoma from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL EQ-5D-5L, and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomisation along with a 12 month review of clinical data. 12 months following randomisation will be considered the primary timepoint for outcome analyses.
Discussion: If the ASICA intervention improves total-skin-self-examination practice in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and NHS resources. This study will determine if a full scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed determine the effectiveness ASICA is a pilot study evaluating the effectiveness of total skin self-examination practice in those affected by melanoma.
Trial Registration: 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.
Keywords: Primary care, Melanoma, Cancer, Randomised Controlled Trial, Survivorship, Self-directed care, e-health, ASICA.
Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at 6‐month follow‐up: protocol for a randomised controlled trial
