Abstract
BackgroundMelanoma 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.MethodsWe 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.DiscussionIf 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 registrationClinical Trials.gov, NCT03328247. Registered on 1 November 2017.
Highlights
Melanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years
If the Achieving Self-directed Integrated Cancer Aftercare (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 study will determine if a full-scale randomised controlled trial can be undertaken in the UK National Health Service (NHS) to provide the high-quality evidence needed to determine the effectiveness of the intervention
Summary
Study design This is a two-arm, open multi-centre randomised controlled trial (RCT) comparing ASICA, a digital intervention to increase TSSE by people treated for melanoma, with usual follow up. Participants will complete a questionnaire collecting data on quality of life (EQ-5D-5 L [29]), anxiety and depression (HADS [30]), worry about melanoma (MWS) [31]), selfreport of health service use, self-report of TSSE practice (frequency and coverage) and ratings of intention, selfefficacy and planning for future TSSE [32]. The research nurse will re-review participants’ medical records at outcome to collect data on skin-related NHS resource use during the study year, including details of any new skin-related diagnoses and details of melanoma follow-up appointments and other. The process evaluation will follow the principles of the Medical Research Council (MRC) process evaluation guidance and will primarily investigate the practical issues around the implementation of the ASICA intervention [33] It will consider how the intervention has produced any observed and statistically significant changes between the intervention and control groups with respect to the primary and secondary outcomes. Sponsor and Research Ethics Committee (REC) approval will be sought for any new proposal, if appropriate
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
