The Achieving Self-directed Integrated Cancer Aftercare Intervention for Detection of Recurrent and Second Primary Melanoma in Survivors of Melanoma: Pilot Randomized Controlled Trial

Abstract

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

Strategies to Improve Adherence to Skin Self-examination and Other Self-management Practices in People at High Risk of Melanoma

“…Studies were from the US, the United Kingdom, and Australia and ranged in size from 40 to 724 participants and in duration from 3 to 24 months (eTable 3 in the Supplement). They included people with personal history of melanoma, patients attending high-risk melanoma clinics, first-degree relatives of people with melanoma, primary care patients assessed as high risk, and previous melanoma trial participants . All interventions aimed to improve SSE practice.…”

“…Many strategies simultaneously targeted several of the 5 WHO dimensions of adherence (adapted for the trial context, Table). Overall, 15 RCTs used trial design, 5 used social and economic support, 18 used intervention design, 10 used intervention support, and 18 used participant support (including the provision of knowledge, skills, and support for behavioral change). Reporting of adherence strategies was rarely sufficiently detailed to allow replication.…”

“…A total of 14 trials limited eligibility criteria to participants likely to be able to adhere to the intervention. Participants were excluded if they had visual impairment, cognitive impairment, comorbidities, or no internet or smartphone access . In the trial by Manahan et al, participants completed a screening questionnaire to confirm acceptance of teledermatology before enrollment .…”

“…A total of 5 trials used strategies that provided social support to participants. Research staff in 2 trials facilitated urgent clinical appointments, another 2 trials provided information on how to access care, and 1 trial enabled calendar scheduling to make a doctor’s appointment . Two trials of an internet-based education tool to improve communication about melanoma risk within families included a chat room for communication between participants .…”

“…The mode, number, and frequency of reminders varied from trial to trial, and reported details were often limited. Options included offering a choice of SMS or email, email prompts every 3 months, monthly in-app notifications, and calendar scheduling . No trials reported the use of incentives (financial or otherwise) to encourage adherence.…”