The MELAcare Study: A New Method for Surveillance of Melanoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cutaneous Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

The MelaCare intervention

Intervention Type OTHER

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.

Control group

Patients in the control arm will receive clinical follow-up according to the current standard of care for their clinical stage.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No