RecruitingNot ApplicableNCT05253872

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

Sponsor

Herlev and Gentofte Hospital

Enrollment

378 participants

Start Date

Mar 9, 2022

Study Type

INTERVENTIONAL

Conditions

Cutaneous Melanoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new follow-up method for melanoma patients who have had their early-stage skin cancer removed. Instead of regular hospital check-ups, participants will be trained to examine their own skin at home. Researchers want to see if this approach keeps patients safe while reducing the burden of frequent clinic visits. **You may be eligible if...** - You can read and understand Danish - You have had a stage IA-IIA melanoma surgically removed within the last 3 months - You are willing to learn and perform regular skin self-exams **You may NOT be eligible if...** - You have advanced melanoma (stage IIB, IIC, III, or IV) - You have dysplastic nevus syndrome or a strong family history of melanoma - You have had a previous melanoma - You have had another cancer (other than non-melanoma skin cancer) - You have a physical or mental disability that makes skin self-examination impossible - Your sentinel lymph node could not be detected (for stage IB-IIA patients) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThe 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.