Background Melanoma is common with increasing incidence. Guidelines recommend monthly total skin self-examinations (TSSEs) by survivors to detect recurrent and new primary melanomas. TSSE is underperformed despite evidence of benefit. Objective This study compares the effect on psychological well-being and TSSE practice of a self-directed digital intervention with treatment as usual in patients treated for a first stage 0 to IIC primary cutaneous melanoma within the preceding 60 months. Methods This randomized clinical trial was conducted at 2 UK National Health Service hospitals (Aberdeen Royal Infirmary, Grampian, and Addenbrooke’s, Cambridge). Adults (≥18 years) diagnosed with a first 0 to IIC primary cutaneous melanoma were randomized to receive Achieving Self-directed Integrated Cancer Aftercare (ASICA), a tablet-based intervention prompting and supporting TSSE in survivors of melanoma, or to usual care. The hypothesis was that ASICA would increase TSSE practice in users affected by melanoma and compared with controls without affecting psychological well-being. The main primary outcomes were melanoma worry (Melanoma Worry Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and quality of life (EQ-5D-5L) as well as secondary outcomes collected using postal questionnaires 3, 6, and 12 months following randomization. Results A total of 240 recruits were randomized (1:1) into the ASICA (n=121, 50.4%) or control (n=119, 49.6%) groups. There were no significant differences between groups for melanoma worry at 12 months (mean difference: 0.12, 95% CI −0.6 to 0.84; P=.74), 3 months (0.23, 95% CI −0.31 to 0.78; P=.40), or 6 months (−0.1, 95% CI −0.7 to 0.51; P=.76). The ASICA group had lower anxiety scores at 12 months (−0.54, 95% CI −1.31 to 0.230; P=.17), 3 months (−0.13, 95% CI −0.79 to 0.54; P=.71), and significantly at 6 months (−1.00, 95% CI −1.74 to −0.26; P=.009). Depression scores were similar, being lower at 12 months (−0.44, 95% CI −1.11 to 0.23; P=.20) and 3 months (−0.24, 95% CI −0.84 to 0.35; P=.42) but only significantly lower at 6 months (−0.77, 95% CI −1.41 to −0.12; P=.02). The ASICA group had significantly higher quality of life scores at 12 months (0.044, 95% CI 0.003-0.085; P=.04) and 6 months (0.070, 95% CI 0.032-0.107; P<.001) and nonsignificantly at 3 months (0.024, 95% CI −0.006 to 0.054; P=.11). ASICA users reported significantly more regular (>5) TSSEs during the study year and significantly higher levels of self-efficacy in conducting TSSE. They also reported significantly higher levels of planning and intention to perform TSSE in the future. Conclusions Using ASICA for 12 months does not increase melanoma worry, can reduce anxiety and depression, and may improve quality of life. ASICA has the potential to improve the well-being and vigilance of survivors of melanoma and enable the benefits of regular TSSE. Trial Registration ClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-019-3453-x
Background Melanoma incidence has quadrupled since 1970 and melanoma is now the second most common cancer in individuals under 50. Targeted immunotherapies for melanoma now potentially enable long-term remission even in advanced melanoma, but these melanoma survivors require ongoing surveillance, with implications for NHS resources and significant social and psychological consequences for patients. Total skin self-examination (TSSE) can detect recurrence earlier and improve clinical outcomes but is underperformed in the UK. To support survivors, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) intervention was developed to prompt and improve TSSE performance, with subsequent reporting of concerns and submission of skin photos to a Dermatology Nurse Practitioner (DNP). ASICA was delivered as a randomized pilot trial. Methods This paper reports on process evaluation. Data on participants’ demographics and the concerns they reported during the trial were tabulated and displayed using Microsoft Excel and SPSS. We explored which participants used ASICA, and how frequently, to report any skin concerns. We also determined how the interactions had worked in terms of quality of skin photographs submitted, clinical assessments made by the DNP, and the assessments and decisions made for each concern. Finally, we explored significant events occurring during the trial. Data on participants’ demographics and the concerns they reported during the trial were tabulated and displayed using SPSS. A semi-structured interview was undertaken with the DNP to gain perspective on the range of concerns presented and how they were resolved. Results Of 121 recruited melanoma patients receiving ASICA for 12 months, 69 participants submitted a total of 123 reports detailing 189 separate skin-related concerns and including 188 skin photographs. Where participants fully complied with follow-up by the DNP, concerns were usually resolved remotely, but 19 (10.1%) were seen at a secondary care clinic and 14 (7.4%) referred to their GP. 49 (25.9%) of concerns were not completely resolved due to partial non-compliance with DNP follow-up. Conclusion Melanoma patients randomized to the ASICA intervention were able to report skin-related concerns that could be resolved remotely through interaction with a DNP. Feasibility issues highlighted by ASICA will support further development and optimization of this digital tool. Trial registration Clinical Trials.gov, NCT03328247. Registered on 1 November 2017
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.
The coronavirus disease 2019 (COVID-19) pandemic has dramatically impacted healthcare provision in the UK and skin cancer services have had to adapt to ensure continuity of safe care. As we return to “normality” we reflect on lessons learned and the impact of the pandemic on skin cancer services. We looked at data on Public Health Scotland Dashboard, which compiles data from 14 local health boards across Scotland, comparing melanoma and non-melanoma skin cancer diagnoses during the years 2020 and 2019 (pre-COVID-19 pandemic). We looked at skin cancer cases within the North Cancer Alliance (NCA) and all of Scotland. Within the NCA, 518 cases of melanoma were diagnosed in 2019, compared to 429 in 2020. Within Scotland, 1950 cases of melanoma were diagnosed in 2019, compared to 1605 in 2020. In 2019, 5103 non-melanoma skin cancer cases were diagnosed in NCA, compared to 4071 in 2020. In Scotland, 21,626 non-melanoma skin cancer cases were diagnosed in 2019, compared to 16,193 in 2020. The COVID-19 pandemic has had a significant impact on skin cancer care within the NCA and the whole of Scotland. A significantly lower number of melanoma and non-melanoma skin cancer cases have been diagnosed within the NCA and in Scotland in 2020 compared to 2019. The trend is similar between NCA and other areas of Scotland. We must raise awareness of melanoma and non-melanoma skin cancer to improve timely presentation of patients during a global health crisis and a multidisciplinary approach is needed to address this problem.
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