Dataset Information

Achieving integrated self-directed Cancer aftercare (ASICA) for melanoma: how a digital intervention to support total skin self-examination was used by people treated for cutaneous melanoma

ABSTRACT:

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

SUBMITTER: Reilly F

PROVIDER: S-EPMC8590778 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMelanoma 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.ObjectiveThis 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.MethodsThis 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.ResultsA 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.ConclusionsUsing 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 registrationClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247.International registered report identifier (irrid)RR2-10.1186/s13063-019-3453-x.

Project description: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.

Project description:BackgroundMelanoma is a relatively common cancer type with a high survival rate, but survivors risk recurrences or second primaries. Consequently, patients receive regular hospital follow-up, but this can be burdensome to attend and not optimally timed to detect arising problems. Total skin self-examination (TSSE) supports improved clinical outcomes from melanoma via earlier detection of recurrences and second primaries, and digital technology has the potential to support TSSE. Recent research with app-based interventions aimed at improving the well-being of older adults has found that they can use the technology and benefit from it, supporting the use of digital health care in diverse demographic groups. Thus, the Achieving Self-directed Integrated Cancer Aftercare (ASICA) digital health care intervention was developed. The intervention provided melanoma survivors with a monthly prompt to perform a TSSE as well as access to a dermatology nurse who provided them with feedback on photographs and descriptions of their skin.ObjectiveWe aimed to explore participants' attitudes, beliefs, and experiences regarding TSSE practices. Furthermore, we explored how participants experienced technology and how it influenced their practice of TSSE. Finally, we explored the practical and technical experiences of ASICA users.MethodsThis was a nested qualitative evaluation within a dual-center randomized controlled trial of the ASICA intervention. We conducted semistructured telephone interviews with the participants during a randomized controlled trial. The participants were purposively sampled to achieve a representative sample with representative proportions by age, sex, and residential geography. Interviews were transcribed verbatim and analyzed using a framework analysis approach applied within NVivo 12.ResultsA total of 22 interviews were conducted with participants from both groups. In total, 40% (9/22) of the interviewed participants were from rural areas, and 60% (13/22) were from urban areas; 60% (13/22) were from the intervention group, and 40% (9/22) were from the control group. Themes evolved around skin-checking behavior, other people's input into skin checking, contribution of health care professionals outside ASICA and its value, ideas around technology, practical experiences, and potential improvements. 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 health care. Overall, ASICA was experienced positively by participants. Several practical suggestions were made for the improvement of ASICA.ConclusionsThe ASICA intervention appeared to have positively influenced the attitudes and TSSE practices of melanoma survivors. This study provides important qualitative information about how a digital health care intervention is an effective means of prompting, recording, and responding to structured TSSE by melanoma survivors. Technical improvements are required, but the app offers promise for technologically enhanced melanoma follow-up in future.Trial registrationClinicalTrials.gov NCT03328247; https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1.International registered report identifier (irrid)RR2-10.1186/s13063-019-3453-x.

Project description:ImportanceSkin self-examination (SSE) is a key factor in the early detection of melanoma, and many new and recurrent melanomas are first detected by patients themselves or their family members.ObjectiveTo explore the views of patients with melanoma regarding SSE in general, as well as their attitudes toward using novel digital technologies to support their own SSE.Design, setting, and participantsQualitative study with semistructured interviews that were conducted from June 20 to December 12, 2016, with 37 individuals in Sydney, Australia, who were previously treated for a first primary localized melanoma during 2014 and had not had a recurrence or new primary melanoma in the time since treatment.Main outcomes and measuresPatients' views and experiences, analyzed thematically.ResultsA total of 37 patients (11 women and 26 men; median age, 67 years [interquartile range, 59.5-72 years]) were interviewed. Participants perceived SSE as important for the early identification of local recurrence or new primary melanomas. Despite this belief, participants did not report undertaking full-body SSE on a regular basis. Factors that influenced their low engagement in thorough SSE included lack of self-efficacy, reliance on clinician consultations as the primary means of melanoma detection, and fear of cancer recurrence. Regarding the use of digital technology to assist with SSE, the key motivating factors in favor of such tools were the ability to track changes in lesions over time and the use of automated reminders to undertake SSE. Deterrents included a lack of confidence in undertaking SSE and in using new technology.Conclusions and relevancePatients with melanoma are aware of the importance of thorough skin examinations. However, a lack of confidence in their ability to undertake SSE and reliance on clinicians as the primary means of melanoma detection may inhibit patients from undertaking regular and thorough SSE. Patients may benefit from new digital technologies that assist them in undertaking SSE, provided they have appropriate education and technical support.