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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05253872
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Herlev and Gentofte Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lisbet R Hölmich, Professor
Principal Investigator Affiliation	Herlev and Gentofte Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Melanoma

Arms & Interventions

Arms

Experimental: 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

No Intervention: Control group

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Herlev and Gentofte Hospital, Copenhagen, Denmark

Status

Recruiting

Address

Herlev and Gentofte Hospital

Copenhagen, , 2730

Site Contact

Sara M Hansen, MD

[email protected]

+4538681296

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