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The MELAcare Study: A New Method for Surveillance of Melanoma Patients
Sponsor: Herlev and Gentofte Hospital
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.
Official title: The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
378
Start Date
2022-03-09
Completion Date
2028-03
Last Updated
2023-06-26
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Herlev and Gentofte Hospital
Copenhagen, Denmark