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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16061621

Enrollment

200

Registered

2016-08-17

Start date

2016-08-15

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma Cancer Melanoma

Interventions

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 o

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Contacts

Public ContactMerel Pannebakker

mmp32@medschl.cam.ac.uk+44 1223 746867

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026