Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

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

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

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.

The MelaCare intervention

Sara M Hansen, MD

Lisbet R Hölmich, Professor

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.

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

There are no plan to share IPD with other researchers.

The primary outcome is the score of the validated 4-item Concerns About Recurrence Questionnaire (CARQ-4). A higher score indicates a higher level of FCR. A score of 12 or above is considered clinically relevant fear of cancer recurrence.

The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity

The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.

The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity

The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level

The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status

The work ability index has a scale from 7-49, where higher scores indicates better work ability.

The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits

The investigators will evaluate number of extra clinical consultations with a doctor the patients will attend at the outpatient clinic. The data will be collected using electronic patient journal.

The investigator will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.

The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.

The investigators will evaluate time to diagnosis of a new melanomas using Breslows thickness as a proxy for time, and time to diagnosis recurrence measured by type of recurrence (local, regional or distant). The data will be collected using medical records.

We will evaluate the health care cost of new follow-up program compared to the current. Data will be collected using national registries.

The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The MELAcare Study: A New Method for Surveillance of Melanoma Patients	NCT05253872	Cutaneous Melan...	The MelaCare in...	18 Years -	Herlev and Gentofte Hospital
The MELAcare Study: A New Method for Surveillance of Melanoma Patients	NCT05253872	Cutaneous Melan...	The MelaCare in...	18 Years -	Herlev and Gentofte Hospital

Spots Global Cancer Trial Database for the melacare intervention