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

Herlev and Gentofte Hospital

Status: Enrolling

Conditions: Cutaneous Melanoma

Treatments: Other: The MelaCare intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05253872

Melacare v1.0

Details and patient eligibility

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.

Enrollment: 378 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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378 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patients in the intervention arm will receive follow-up conducted by melanoma nurses, where the patients will get tools to cope with the melanoma diagnosis and structured training in skin self-examination

Treatment:

Other: The MelaCare intervention

Control group

No Intervention group

Description:

Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage.