Actively Recruiting
The MELAcare Study: A New Method for Surveillance of Melanoma Patients
Led by Herlev and Gentofte Hospital · Updated on 2023-06-26
378
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
Sponsors
H
Herlev and Gentofte Hospital
Lead Sponsor
D
Danish Cancer Society
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
The MELAcare Study: A New Method for Surveillance of Melanoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Herlev and Gentofte Hospital
Copenhagen, Denmark, 2730
Actively Recruiting
Research Team
S
Sara M Hansen, MD
CONTACT
L
Lisbet R Hölmich, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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