The MELAcare Study: A New Method for Surveillance of Melanoma Patients
Recruiting · NCT05253872 · Interventional (participants receive a specific treatment) · Lead sponsor: Herlev and Gentofte Hospital
View the official record on ClinicalTrials.gov →Interventions studied
The MelaCare intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Herlev and Gentofte Hospital - Copenhagen, Denmark