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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 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 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. METHODS This randomized clinical trial was conducted at two UK NHS hospitals (Aberdeen Royal Infirmary, Grampian and Addenbrookes, Cambridge). Adults (aged ≥18) diagnosed with a first 0-IIC primary cutaneous melanoma were randomised to receive ASICA (Achieving Self-directed Integrated Cancer Aftercare) a tablet-based digital intervention to prompt and support TSSE in melanoma survivors, or to usual care. 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. The main outcomes 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. CLINICALTRIAL 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. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-019-3453-x
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