The MELAcare Study: A New Method for Surveillance of Melanoma Patients

Recruiting now · Not applicable

Conditions studied: Cutaneous Melanoma

In brief

The aim of this study is to evaluate a new method of follow-up for patients with low and intermediate risk (stages IA-IIA) melanoma. The investigators will compare different tools for patient support and education combined with clinician supported skin self-examination (SSE) to the current standard-of-care. The hypothesis is that meta-cognitive strategies and clinician supported SSE can lower fear of cancer recurrence (FCR) and promote effective SSE on a regular basis without compromising the detection of new primary melanomas and/or metastases.

Key facts

Study ID

NCT05253872

Run by

Herlev and Gentofte Hospital

People needed

378

Starts

2022-03-09

Expected to finish

2028-03-01

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to read and understand Danish language
• Willing and able to give written informed consent
• Surgical treatment of a clinical stage IA-IIA melanoma within 3 months of inclusion

You may not qualify if…

• Advanced melanoma, clinical stages IIB, IIC, III, or IV
• Patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma)
• History of melanoma skin cancer prior to the index diagnosis
• Previous cancer, excluding non-melanoma skin cancer
• Comorbidity that makes skin self-examination impossible (e.g. physical or mental disabilities, dementia or decreased cognitive function)
• non-detection of sentinel node in IB and IIA patients

Where it is running

• Herlev and Gentofte Hospital — Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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