RecruitingRecruiting
The MELAcare Study: A New Method for Surveillance of Melanoma Patients
NCT05253872 · Herlev and Gentofte Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
About this study
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.
Eligibility 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
Study design
Enrollment target: 378 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2022-03-09
Estimated completion: 2028-03
Last updated: 2023-06-26
Interventions
Other: The MelaCare intervention
Primary outcomes
- • Fear of cancer recurrence (The primary outcome will be evaluated at approx. 6-8 months after randomization.)
- • Fear of cancer recurrence (The primary outcome will be evaluated at approx. 12 months follow-up)
- • Fear of cancer recurrence (The primary outcome will be evaluated at approx. 24 months follow-up)
Sponsor
Herlev and Gentofte Hospital · other
With: Danish Cancer Society
Contacts & investigators
ContactSara M Hansen, MD · contact · sara.moelgaard.hansen@regionh.dk · +4538681296
ContactLisbet R Hölmich, Professor · contact · lisbet.rosenkrantz.hoelmich@regionh.dk · +4538681243
InvestigatorLisbet R Hölmich, Professor · study_chair, Herlev and Gentofte Hospital
All locations (1)
Herlev and Gentofte HospitalRecruiting
Copenhagen, Denmark