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
Abstract: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 imp… Show more
“…Trial participants in the intervention arm will receive the intervention (patient-led surveillance) as an adjunct to their usual care, including: An educational booklet ‘Your guide to early melanoma’; Routinely scheduled visits as recommended by their treating clinician; Unscheduled clinic visits, if needed (not prompted through teledermatology); Continued access to the ASICA skin checker instructional videos on how to perform SSE (including checking for locoregional recurrence) [ 30 , 39 ]; A mobile dermatoscope (with a polarised or non-polarised light source) to attach to their phone, with detailed written and video instructions on how to use the smartphone app and dermatoscope Training for themselves and a partner/friend/support person in using the dermatoscope and app, delivered one-on-one by web conferencing; Email or SMS text reminders every 3 months to perform SSE; Teledermatology (see Fig. 2 ) Fig.…”
Section: Methods: Participants Interventions and Outcomesmentioning
confidence: 99%
“…Continued access to the ASICA skin checker instructional videos on how to perform SSE (including checking for locoregional recurrence) [ 30 , 39 ];…”
Section: Methods: Participants Interventions and Outcomesmentioning
Background
Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma.
Methods
Stage 0/I/II melanoma patients (n = 600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n = 300) or control (usual care, n = 300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n = 150) or non-polarised (n = 150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician’s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician’s usual practice.
The primary outcome, measured at 12 months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised).
Discussion
The findings from this study may inform guidance on evidence-based follow-up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society.
Trial registration
Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered on 18 February 2021.
“…Trial participants in the intervention arm will receive the intervention (patient-led surveillance) as an adjunct to their usual care, including: An educational booklet ‘Your guide to early melanoma’; Routinely scheduled visits as recommended by their treating clinician; Unscheduled clinic visits, if needed (not prompted through teledermatology); Continued access to the ASICA skin checker instructional videos on how to perform SSE (including checking for locoregional recurrence) [ 30 , 39 ]; A mobile dermatoscope (with a polarised or non-polarised light source) to attach to their phone, with detailed written and video instructions on how to use the smartphone app and dermatoscope Training for themselves and a partner/friend/support person in using the dermatoscope and app, delivered one-on-one by web conferencing; Email or SMS text reminders every 3 months to perform SSE; Teledermatology (see Fig. 2 ) Fig.…”
Section: Methods: Participants Interventions and Outcomesmentioning
confidence: 99%
“…Continued access to the ASICA skin checker instructional videos on how to perform SSE (including checking for locoregional recurrence) [ 30 , 39 ];…”
Section: Methods: Participants Interventions and Outcomesmentioning
Background
Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma.
Methods
Stage 0/I/II melanoma patients (n = 600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n = 300) or control (usual care, n = 300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n = 150) or non-polarised (n = 150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician’s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician’s usual practice.
The primary outcome, measured at 12 months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised).
Discussion
The findings from this study may inform guidance on evidence-based follow-up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society.
Trial registration
Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered on 18 February 2021.
“…It was also said that it is important that apps contain enough information for them to be used effectively and that they signpost the user to further help if needed. In the ASICA trial, the primary outcomes measured were psychological wellbeing and quality of life measured by the Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADS) and the EQ5-D. [Murchie et al, 2019] A mixture of views were expressed on this point by the users interviewed here. Two participants indicated an initial increase in concern when they began using ASICA but suggested this decreased as they continued to use it.…”
BackgroundMelanoma is a common cancer with a high survival rate, as well as a high chance of recurrence. Combined, this leads to a high burden of follow-up. Total-Skin-Self-Examination (TSSE) improves clinical outcomes of melanoma via early detection of new primaries and recurrences, and technology is an increasingly popular means of facilitating TSSE. Thus, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) digital healthcare intervention was developed. Embedded within a randomised control trial (RCT), this nested study used qualitative interviews to explore in depth participants’ experiences of TSSE, their orientation toward technology and both participant and professionals’ practical and technical experiences of the ASICA intervention.MethodsSemi-structured telephone interviews were undertaken during the RCT with participants and the coordinating Dermatology Nurse Practitioner (DNP). Participants were purposively sampled to achieve a representative sample. Interviews were transcribed verbatim and analysed using a Framework Analysis approach applied within NVivo12.ResultsTwenty-two interviews were completed with participants and one with the coordinating DNP. ASICA appeared to change participants’ perceptions of skin checking: users were more likely to report routinely performing TSSE thoroughly. There was some variation in beliefs about skin-checking and using technology for healthcare generally. Overall, ASICA was experienced positively by participants and the DNP. Several clear practical suggestions were made for how ASICA can be improved.ConclusionThe ASICA app appears to have positively influenced the attitudes and TSSE practices of melanoma survivors. Technical improvements are required, but the app offers promise for technologically enhanced melanoma follow-up in future.Trial RegistrationClinical Trials.gov, NCT03328247. Registered on 1 November 2017 - https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1
“…1 ). Following development and feasibility testing, ASICA has undergone a feasibility randomised controlled trial (RCT) with a nested qualitative component to gather data on the experiences of users and intermediate clinical outcomes (to be reported elsewhere) [ 22 ]. The ASICA clinical trial aimed to improve clinical outcomes of melanoma recurrence and reduce the burden on patients and health services [ 22 ].…”
Section: Introductionmentioning
confidence: 99%
“…Following development and feasibility testing, ASICA has undergone a feasibility randomised controlled trial (RCT) with a nested qualitative component to gather data on the experiences of users and intermediate clinical outcomes (to be reported elsewhere) [ 22 ]. The ASICA clinical trial aimed to improve clinical outcomes of melanoma recurrence and reduce the burden on patients and health services [ 22 ]. If the trial, completed in April 2020 (to be reported elsewhere), shows positive outcomes, the ASICA app may become a useful tool in melanoma aftercare within the NHS, particularly in rural areas.…”
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
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
