A new method for monitoring melanoma patients
The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
This study tests a new way to support and educate patients with low to intermediate risk melanoma to see if it helps them feel less anxious about cancer coming back and encourages them to check their skin regularly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 378 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05253872 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel follow-up approach for patients with low and intermediate risk melanoma (stages IA-IIA). It compares various patient support and education tools, along with clinician-supported skin self-examination (SSE), against the current standard care. The goal is to reduce fear of cancer recurrence and encourage regular SSE without compromising the detection of new melanomas or metastases.
Who should consider this trial
Good fit: Ideal candidates are patients with clinical stage IA-IIA melanoma who can read and understand Danish and are willing to provide informed consent.
Not a fit: Patients with advanced melanoma or those at high risk for new primary melanomas will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient self-management and reduce anxiety related to cancer recurrence.
How similar studies have performed: Other studies have shown promise in using self-examination and supportive strategies for cancer follow-up, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen
- Herlev and Gentofte Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Sara M Hansen, MD
- Email: sara.moelgaard.hansen@regionh.dk
- Phone: +4538681296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.