Clinical trial · Interventional
The MELAcare Study: A New Method for Surveillance of Melanoma Patients
The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The MelaCare intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention 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
- interventionNames
- Other: The MelaCare intervention
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage.
Primary outcomes (3)
- measure
- Fear of cancer recurrence
- timeFrame
- The primary outcome will be evaluated at approx. 6-8 months after randomization.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHansen SM, Johansen C, Kasparian NA, Grand MK, Bidstrup PE, Holmich LR. Employing skin self-examination and fear of cancer recurrence management in early-stage melanoma follow-up: evaluation of the MELACARE intervention in a randomised controlled trial. J Cancer Surviv. 2025 Jun 12. doi: 10.1007/s11764-025-01841-1. Online ahead of print. PMID 40504479