Patient-led Surveillance Compared to Clinician-led Surveillance in People Treated for Localised Melanoma. (MEL-SELF)

University of Sydney

Status: Completed

Conditions: Melanoma (Skin)

Treatments: Behavioral: Clinician-led surveillance; Device: Patient-led surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT03581188

ACTRN12616001716459 (Registry Identifier)

ANZMTG 02.17

Details and patient eligibility

About

The purpose of this pilot study is to evaluate digitally supported skin self-examination compared to usual care in people treated for localised melanoma.

Full description

Patients may be eligible to join this study if they are aged 18 years or above, have been treated for stage 0/I/II melanoma and are attending regular melanoma surveillance follow-ups at the Melanoma Institute Australia (MIA), Royal Prince Alfred Hospital (RPAH) or the Newcastle Skin Check Clinic.

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 ratio. 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 the intervention group will be required to download a skin checker App to their smartphone and will use a mobile dermatoscope to perform total body skin self-examinations every 2 months for 6 months in total. Email and SMS reminders will also be sent every two months to participants in the intervention group. Participants will be documented on how well they are able to perform a self skin 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients treated for stage 0/I/II melanoma and 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);
• Have a smart phone with 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;

Exclusion criteria

• Unable to perform self-examination
• No partner or friend to help with self-examination
• Do not have access to a smart phone with Wifi/email/SMS text messaging
• With a known past or current diagnosis of cognitive impairment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patient-led surveillance

Experimental group

Description:

Participants receive a mobile dermatoscope that attaches to their smartphone to take photos of skin lesions for teledermatology, instructions on skin self-examination from the ASICA skin checker App, text and email reminders to perform self-examination every 2 months, an educational booklet 'Your guide to early melanoma', and scheduled visits to their clinician as required.

Treatment:

Device: Patient-led surveillance

Clinician-led surveillance

Active Comparator group

Description:

Participants receive an educational booklet 'Your guide to early melanoma' and scheduled visits to their clinician as required.

Treatment:

Behavioral: Clinician-led surveillance