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

NCT05253872 | Recruiting

• 1 other identifier: Melacare v1.0
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Melanoma

Keywords

cutaneous melanoma; follow-up; nurse-led follow-up; skin self-examination; survivorship

Outcome Measures

Primary Outcomes (3)

• Fear of cancer recurrence

  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 primary outcome will be evaluated at approx. 6-8 months after randomization.

• Fear of cancer recurrence

  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 primary outcome will be evaluated at approx. 12 months follow-up

• Fear of cancer recurrence

  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 primary outcome will be evaluated at approx. 24 months follow-up

Secondary Outcomes (38)

• Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)

  Depression score will be evaluated at approx. 6-8 months after randomization.

• Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)

  Depression score will be evaluated at approx. 12 months follow-up

• Evaluation of change from in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)

  Depression score will be evaluated at 24 months follow-up

• Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)

  Anxiety score will be evaluated at approx. 6-8 months after randomization.

• Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)

  Anxiety score will be evaluated at approx.12 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: The MelaCare intervention

Control group

NO INTERVENTION

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

Interventions

The MelaCare intervention 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to read and understand Danish language
• Willing and able to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Herlev and Gentofte Hospital

Copenhagen, 2730, Denmark

RECRUITING

Related Publications (1)

• Hansen SM, Johansen C, Kasparian NA, Grand MK, Bidstrup PE, Holmich LR. Employing skin self-examination and fear of cancer recurrence management in early-stage melanoma follow-up: evaluation of the MELACARE intervention in a randomised controlled trial. J Cancer Surviv. 2025 Jun 12. doi: 10.1007/s11764-025-01841-1. Online ahead of print.

  PMID: 40504479 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lisbet R Hölmich, Professor

  Herlev and Gentofte Hospital

  STUDY CHAIR

Central Study Contacts

Sara M Hansen, MD

CONTACT

+4538681296; sara.moelgaard.hansen@regionh.dk

Lisbet R Hölmich, Professor

CONTACT

+4538681243; lisbet.rosenkrantz.hoelmich@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 24, 2022
• Study Start: March 9, 2022
• Primary Completion: June 1, 2024
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)