MelaTools skin self-monitoring study for primary care patients at higher risk of melanoma

Not Applicable

Completed

• Conditions: Melanoma; Cancer

• Registration Number: ISRCTN16061621
• Lead Sponsor: niversity of Cambridge

Brief Summary

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32101302 results (added 27/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-17
• Study Completion: 2018-03-31
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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

Name	Time	Method
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<br>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<br>3. Melanoma incidence across participating practices, to contextualise trial findings and after 5 years identified by data collected from primary care records