Protocol for the MelaTools Skin Self-Monitoring Trial: a phase II randomised controlled trial of an intervention for primary care patients at higher risk of melanoma

K Mills (Corresponding Author), JD Emery, R Lantaff, M Radford, MM Pannebakker, P Hall, NP Burrows, KM Williams, CL Saunders, Peter Murchie, Fiona M Walter

Research output: Contribution to journalArticlepeer-review

5 Citations (Scopus)
12 Downloads (Pure)


Melanoma is the fifth commonest 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 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 a skin self-monitoring ‘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: ISCTRN registry, ISCTRN16061621
Original languageEnglish
Article number017934
JournalBMJ Open
Early online date28 Nov 2017
Publication statusPublished - Nov 2017

Bibliographical note

This work was 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 funding source has no role in the design of this study, the interpretation of data, or the decision to submit results.
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. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health,


  • melanoma
  • skin cancer
  • randomised controlled trial
  • risk-stratified
  • primary care


Dive into the research topics of 'Protocol for the MelaTools Skin Self-Monitoring Trial: a phase II randomised controlled trial of an intervention for primary care patients at higher risk of melanoma'. Together they form a unique fingerprint.

Cite this