Introduction Melanoma is the fifth most common cancer in the UK. Incidence rates have quadrupled over the last 30 years and continue to rise, especially among younger people. As routine screening of the general population is not currently recommended in the UK, a focus on secondary prevention through early detection and prompt treatment in individuals at increased risk of melanoma could make an important contribution to improve melanoma outcomes. This paper describes the protocol for a phase II, multisite, randomised controlled trial, in the primary care setting, for patients at increased risk of melanoma. A skin self-monitoring (SSM) smartphone ‘App’ was used to improve symptom appraisal and encourage help seeking in primary care, thereby promoting early presentation with skin changes suspicious of melanoma.
Methods and analysis We aim to recruit 200 participants from general practice waiting rooms in the East of England. Eligible patients are those identified at higher melanoma risk (using a real-time risk assessment tool), without a personal history of melanoma, aged 18 to 75 years. Participants will be invited to a primary care nurse consultation, and randomised to the intervention group (standard written advice on skin cancer detection and sun protection, loading of an SSM ‘App’ onto the participant’s smartphone and instructions on use including self-monitoring reminders) or control group (standard written advice alone). The primary outcomes are consultation rates for changes to a pigmented skin lesion, and the patient interval (time from first noticing a skin change to consultation). Secondary outcomes include patient sun protection behaviours, psychosocial outcomes, and measures of trial feasibility and acceptability.
Ethics and dissemination NHS ethical approval has been obtained from Cambridgeshire and Hertfordshire research ethics committee (REC reference 16/EE/0248). The findings from the MelaTools SSM Trial will be disseminated widely through peer-reviewed publications and scientific conferences.
Trial registration number ISRCTN16061621.
- skin cancer
- randomised controlled trial
- primary care
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Contributors FMW and JE developed the initial idea for the trial, and all authors (except MP) have assisted with the development of the protocol, study design and refinement of study materials. PM and JE provided experience of primary care trials, and NB and PH provided clinical expertise. MR led the 2015 SSM Apps review. KM conducted the focus groups and interviews, and led trial preparations with RL and MP, and supported by trials and governance expertise from KW. CS is leading the statistical analysis. KM and FMW wrote the manuscript and revised it in response to critical revisions from all authors. FMW is the guarantor of the study. The International Committee of Medical Journal Editors authorship eligibility guidelines have been followed and no professional writers have been used.
Funding This study is supported by the UK Clinical Research Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners, which is part-funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London and the NIHR Evaluation, Trials and Studies Coordinating Centre. This work was also supported by FMW’s Clinician Scientist award (RG 68235) from the National Institute for Health Research (NIHR). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health. The paper also presents independent research funded/supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research & Care (CLAHRC) East of England, at Cambridgeshire and Peterborough NHS Foundation Trust.
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Ethics approval Cambridgeshire and Hertfordshire NHS REC committee, reference 16/EE/0248, protocol version 2 24th June 2016. Requests for the final dataset should be addressedto the corresponding author.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement A summary of the results will be disseminated to the study participants. We plan to publish the main trial outcomes in a single paper. Further publications are anticipated after exploring the data in more detail relating to implementation of this novel intervention. Findings will be presented at national and international conferences from late 2018.