NCT05253872Recruiting
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 · Last updated 26 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 378 (estimated)
- First submitted
- 24 Jan 2022
- Start date
- 9 Mar 2022
- Primary completion date
- Jun 2024
- Lead sponsor
- Herlev and Gentofte Hospital
- Diseases
- Melanoma
- NCT number
- NCT05253872
What you commit to
- Study type: Interventional
- Planned participants: 378
- From 9 Mar 2022 to the primary completion date, Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of melanoma skin cancer prior to the index diagnosis
Other illness
- Patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma)
- 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)
Other
- Advanced melanoma, clinical stages IIB, IIC, III, or IV
- non-detection of sentinel node in IB and IIA patients
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.