Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma.
P Murchie, J Masthoff, F M Walter, K Rahman, J L Allan, N Burrows, C Proby, A J Lee, M Johnston, A Durrani, I Depasquale, B Brant, A Neilson, F Meredith, S Treweek, S Hall, A McDonald
Author Information
P Murchie: Academic Primary Care Research Group, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. p.murchie@abdn.ac.uk. ORCID
J Masthoff: Department of Computing Science, University of Aberdeen, Meston Building, King's College, Aberdeeen, AB24 3UE, UK.
F M Walter: The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, CB1 8SR, UK.
K Rahman: Aberdeen Royal Infirmary, NHS Grampian, Foresterhill, Aberdeen, AB25 2ZN, UK.
J L Allan: Health Psychology Group, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
N Burrows: Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.
C Proby: University of Dundee, Division of Cancer Research, James Arrott Drive, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK.
A J Lee: Medical Statistics Group, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
M Johnston: Health Psychology Group, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
A Durrani: Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.
I Depasquale: Aberdeen Royal Infirmary, NHS Grampian, Foresterhill, Aberdeen, AB25 2ZN, UK.
B Brant: NHS Grampian, Dr Gray's Hospital, Elgin, IV30 1SN, UK.
A Neilson: Academic Primary Care Research Group, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
F Meredith: Aberdeen Royal Infirmary, NHS Grampian, Foresterhill, Aberdeen, AB25 2ZN, UK.
S Treweek: Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
S Hall: Academic Primary Care Research Group, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
A McDonald: Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
BACKGROUND: Melanoma is common; 15,906 people in the UK were diagnosed with Melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK guidelines recommend people treated for cutaneous Melanoma receive extended outpatient, hospital follow up to detect recurrence or new primaries. Such follow up of 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 either is highest in the first 5 years. Achieving Self-directed Integrated Cancer Aftercare (ASICA) 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 5-dimension 5-level questionnaire (EQ-5D-5 L), 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 randomization, along with a 12-month review of clinical data. The primary timepoint for outcome analyses will be12 months after randomisation. DISCUSSION: If the ASICA intervention improves the practice of TSSE 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 National Health Service (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 to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by Melanoma. TRIAL REGISTRATION: Clinical Trials.gov, NCT03328247 . Registered on 1 November 2017.
