The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Herlev and Gentofte Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Sara M Hansen, MD
sara.moelgaard.hansen@regionh.dk
+4538681296
Backup
Lisbet R Hölmich, Professor
lisbet.rosenkrantz.hoelmich@regionh.dk
+4538681243
Time Frame
Start Date: 2022-03-09
Estimated Completion Date: 2028-03
Participants
Target number of participants: 378
Treatments
Experimental: Intervention group
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
No_intervention: Control group
Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage.
Related Therapeutic Areas
Sponsors
Leads: Herlev and Gentofte Hospital
Collaborators: Danish Cancer Society