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A research study of digitally supported skin self-examination compared to usual care in people treated for localised melanoma

A pilot randomised controlled trial of digitally supported skin self-examination compared to usual care in people treated for localised melanoma

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001716459
Acronym
MEL-SELF
Enrollment
100
Registered
2016-12-14
Start date
2018-11-12
Completion date
2019-05-24
Last updated
2020-05-04

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

Conditions

None listed

Brief summary

The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been treated for stage 0/I/II melanoma who are attending regular melanoma follow-ups at the Melanoma Institute Australia (MIA), Royal Prince Alfred Hospital (RPAH) and the Newcastle Skin Check . Study details People who are found to be eligible and who consent to participate will be randomised (allocated by chance) to the intervention or usual care in a 1:1 ration. Usual care group will receive an educational booklet on early melanoma and the usual number of routine clinic visits. In addition to usual care, participants allocated to intervention group will download the MoleScope app on to a smartphone and a mobile dermatoscope which they will use to perform total self-examinations every 2 months for 12 months in total along with a web-based ASICA app survey. Email and SMS reminders will also be sent every two months to participants in the intervention group. We will document how well participants are able to perform self-examination, their levels of melanoma-related anxiety, the number of skin lesions biopsied or removed, and the costs of follow-up to the participant and to the healthcare system. Frequent follow-up of localised melanoma is time and resource intensive, and has not shown improved outcomes. This pilot study will provide evidence on which model is best for follow-up care after treatment for localised melanoma

Interventions

Participants allocated to the intervention will receive: • An educational booklet ‘Your guide to early melanoma’, • Web-based ASICA skin checker log-in. The web-based ASICA skin checker combines instructional videos, guided total skin self-examination and electronic reporting,15 • A dermatoscope to attach to their phone similar to that reported in Manahan et al.16. • Detailed written instructions on how to use the Molescope App and dermatoscope. • Training on how to use Molescope App and derma

Participants allocated to the intervention will receive: • An educational booklet ‘Your guide to early melanoma’, • Web-based ASICA skin checker log-in. The web-based ASICA skin checker combines instructional videos, guided total skin self-examination and electronic reporting,15 • A dermatoscope to attach to their phone similar to that reported in Manahan et al.16. • Detailed written instructions on how to use the Molescope App and dermatoscope. • Training on how to use Molescope App and dermatoscope in the form of Face to face training and/or training via live or recorded webinar. Patients may be invited to attend study sites for face to face training and/or offered training by webinar. This training will be conducted by site staff and/or qualified Molescope trainers. • Email and SMS text reminders every 2 months to perform SSE. • Teledermoscopy: participants are required to take dermoscopic images of at least 3 lesions and up to 9 lesions on each SSE, including all lesions that concern them, and submit these through the dermatoscope App (Molescope App). They are also required to enter a text description of the results of SSE for each part of the body and submit this through the web-based ASICA skin checker. Both dermoscopic images and text reports will be sent securely to one of the study dermatologists, who will undertake teledermatology review within 3 days and feedback the results to the participant. • Unscheduled visits as needed in addition to those prompted through Teledermatology. • Scheduled visits as per treating clinician All participants will receive three study questionnaires; one at baseline, one at 6 months and at 12 months.

Sponsors

Dr Catherine Bell
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Patients treated for stage 0/I/II melanoma who are attending regular melanoma follow-up as indicated by scheduled visit within next 12 months in clinic patient booking system and; • Are able to self-examine; • Have a suitable study partner (spouse, partner, family member, friend); • Own a Smartphone (and have access to Wifi / email / SMS text messaging); • Are able to give informed consent; • Have sufficient English language skills to read the materials and complete the questionnaires; • Aged 18+ years old.

Exclusion criteria

• Unable to perform self-examination • No partner or friend to help with self-examination • Do not own a Smartphone • With a known past or current diagnosis of cognitive impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026