Condition category
Cancer
Date applied
09/08/2016
Date assigned
17/08/2016
Last edited
18/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Melanoma is a common skin cancer that can spread to other organs in the body. It Is the leading cause of skin cancer deaths in the UK. If the disease is not diagnosed early enough the cancer will spread and may result in death. Early, timely detection and prompt treatment can therefore make the difference as to whether someone recovers from melanoma or not. The use of a smartphone application for detecting skin changes could potentially assist in earlier diagnosis of melanoma, in prompting users to monitor their skin over time, and in suggesting professional, timely review of any suspicious moles detected. The purpose of this study is to test a novel skin self-monitoring (SSM) intervention (a smartphone app) in general practice aimed at promoting timely consulting by people that are considered to be at particular risk of developing melanoma.

Who can participate?
Patients aged 18-75 years old considered to be at higher than average risk of melanoma (roughly 25% of the UK population) will be recruited from GP practices in the East of England.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) have a standard consultation about prevention of skin cancer with the research nurse. They are then asked to use the SSM app for 12 months. Those in group 2 (control group) also have the consultation but are not given the SSM app. All participants in both groups are asked to complete a questionnaire about their health with the nurse and after 6 and 12 months. If participants go to see their GP or practice nurse about a skin change or mole during the study, they are also be asked to complete a questionnaire about why they decided to go.

What are the possible benefits and risks of participating?
Although there are no direct benefits for people taking part in this study, it is possible that they may find a skin change or mole that concerns them. If this happens, they are advised to make an appointment with their GP to have this checked. By taking part, participants will be contributing to research that could help patients and doctors in the future.

Where is the study run from?
The study is being organised by the Primary Care Unit, University of Cambridge and run in GP practices in the East of England.

When is study starting and how long is it expected to run for?
April 2016 to March 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Katie Mills
ko298@medschl.cam.ac.uk

Trial website

http://www.melatools.org

Contact information

Type

Public

Primary contact

Dr Katie Mills

ORCID ID

Contact details

Primary Care Unit
Strangeways Research Laboratory
2 Worts Causeway
Cambridge
CB1 8RN
United Kingdom
+44 1223 746867
ko298@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Skin self-monitoring for primary care patients at higher risk of melanoma: a phase II randomised controlled trial

Acronym

MelaTools-SSM Trial

Study hypothesis

1. The MelaTools SSM Trial intervention (use of a skin self-monitoring smartphone application) will increase the number of consultations for pigmented skin lesions in people at above-population risk of melanoma
2. The MelaTools SSM Trial intervention will be acceptable and will reduce the patient interval (including symptom appraisal and help-seeking intervals) in people at above-population risk of melanoma
3. The MelaTools SSM Trial intervention will not cause significant distress or worry in people at above population risk of melanoma

Ethics approval

East of England - Cambridgeshire and Hertfordshire Research Ethics Committee, 11/07/2016, ref: 16/EE/0248

Study design

Phase II multi-site randomised controlled feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Other

Patient information sheet

Not available in web format; please use the contact details to request an participant information sheet.

Condition

Melanoma

Intervention

All participants will attend a consultation with a research nurse. With all participants, the nurse will follow a scripted explanation of the standardised information on skin cancer detection, based on Cancer Research UK’s publications ‘Skin Cancer: How to spot the signs and symptoms’, and ‘Be sun-smart: cut your cancer risk’. All participants will be given these leaflets.

Participants will then be randomised 1:1 to either the control arm (standard information) or to the intervention arm (standard information and SSM App). A block randomisation method, using computer-generated, randomly permuted blocks of size 2, 4, and 6, established by a professional independent randomisation service, will be applied. Research nurses will log into an online system during the trial consultation at the point of randomisation.

With the help of the research nurse the intervention participants will then install the SSM App onto their smartphone during this consultation, and be given instructions how to use it. They will be asked to use the App for 12 months.

All participants will be sent follow up questionnaires at 6 and 12 months following randomisation.

More info about the SSM App:
The SSM App used in the trial is an existing App that is available on both the Android and Apple App stores. It encourages skin self-monitoring by photography of moles and provides reminder prompts to repeat this at intervals defined by the user. Photographs taken can be mapped to a body part and notes can be written to describe features of the mole for future reference. Photographs taken prior to usage of the App can also be imported for comparison. There is also the facility to complete a full body scan of all moles. In addition, the ABCDE-signs of melanoma guidance is available for reference.

Intervention type

Phase

Drug names

Primary outcome measures

1. Consultation rates for any skin changes/pigmented skin lesions presented to their GP/practice nurse during the 12 months following the trial consultation compared with the 12 months prior to the trial and; identified by auditing the general practice electronic medical records. All actions taken during the consultation will be recorded including: diagnosis, referral, excision in the GP surgery, advice to monitor.
2. The patient interval (time from first noticing a skin change to presentation) for all skin changes/pigmented skin lesions presented to their GP/practice nurse during the 12 months following the trial consultation. This will be measured by the completion of a skin questionnaire sent to the participant after presentation to their GP/practice nurse.

Secondary outcome measures

1. Patient-Reported Outcomes, including: sun protection habits, skin self-examination, melanoma worry and perceived melanoma risk, self-efficacy for consulting without delay; anxiety, depression and quality of life. This will be measured by the completion of a baseline questionnaire, 6 month and 12 month follow up questionnaires
2. Trial feasibility and acceptability, including: data on patient recruitment, attrition, and response rates to outcome measures to inform decisions about a future phase III trial
3. Melanoma incidence across participating practices, to contextualise trial findings and after 5 years identified by data collected from primary care records

Overall trial start date

01/04/2016

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 18-75 years
2. Own a smartphone

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Severe psychiatric or cognitive disorder
2. Inability to read English to a reasonable standard
3. Physical disorder severe enough to inhibit the use of a smartphone

Recruitment start date

15/08/2016

Recruitment end date

15/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Linton Health Centre
Coles Lane Linton
Cambridgeshire
CB21 4JS
United Kingdom

Trial participating centre

Sawston Medical Centre
London Road Sawston
Cambridgeshire
CB22 3HU
United Kingdom

Trial participating centre

New Queen Street Surgery
Syers Lane Whittlesey
Peterborough
PE7 1AT
United Kingdom

Trial participating centre

Royston Health Centre
Melbourn Street
Royston
SG8 7BS
United Kingdom

Trial participating centre

Flitwick Health Clinic
Highlands Flitwick
Bedfordshire
MK45 1DZ
United Kingdom

Trial participating centre

De Parys Medical Centre
23 De Parys Avenue Bedford
Bedfordshire
MK40 2TX
United Kingdom

Trial participating centre

Beccles Medical Centre
St Mary’s Road Beccles
Norfolk
NR34 9NX
United Kingdom

Trial participating centre

Sheringham Medical Centre
Cromer Road Sheringham
Norfolk
NR26 8RT
United Kingdom

Trial participating centre

Wymondham Medical Centre
18 Bridewell Street Wymondham
Norfolk
NR18 OAR
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

Research Operations Office
School of Clinical Medicine
Addenbrooke's Hospital
Box 111
Cambridge
CB2 0SP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. The trial findings will be disseminated at national and international meetings such as Society for Academic Primary Care , and Cancer Primary Care Research International meeting
2. Findings will be published in high-impact peer reviewed journals with the intention to publish within 12 months of the trial completion (December 2018)

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/08/2016: Internal review