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Taking people in DenmarkNo phase

Tests a new follow-up method for people with early-stage melanoma

Tests a new self-check follow-up method in adults with early melanoma.

Plain-language title generated from the registry record
Registry title: The MELAcare Study: A New Method for Surveillance of Melanoma Patients

Key facts

Where
Copenhagen, DenmarkSee the site

Where in Denmark

  • Herlev and Gentofte HospitalCopenhagen, DenmarkTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Herlev and Gentofte Hospital
Trial code
NCT05253872
Record updated
26 June 2023
Original description
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.Read full original descriptionShow less

The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients

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.

Inclusion: 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.

Exclusion: History of melanoma skin cancer prior to the index diagnosis; Patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma); 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); Advanced melanoma, clinical stages IIB, IIC, III, or IV; non-detection of sentinel node in IB and IIA patients.

ClinicalTrials.gov NCT05253872