NCT05253872

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 378 (estimated)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Melanoma

Interventions

Type	Name	Description
OTHER	The MelaCare intervention	The primary principles applied will be: * Meta-cognitive strategies and normalization of emotions * Self efficacy related to SSE and knowledge on when to seek a doctor for clinical examination The intervention will include 4 components: * An educational booklet * Doctor consultation to ensure correct SSE skills and compliance to the protocol * 3-5 sessions with a experienced and specially trained melanoma nurse * Use of patients' answers from the Patient Reported Outcome 'Functional Assessment of Cancer Treatment - Melanoma' (FACT-M) at the nurse sessions to address current emotional and/or physical sequelae.

Timeline

• Start date: 2022-03-09
• Primary completion: 2024-06-01
• Completion: 2028-03-01
• First posted: 2022-02-24
• Last updated: 2023-06-26

Locations

1 site across 1 country: Denmark