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

Официальное название

The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients

Обзор

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.

Вмешательства

• Другое 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 Assessmen

Первичные конечные точки

• Fear of cancer recurrence [Срок оценки: The primary outcome will be evaluated at approx. 6-8 months after randomization.]
• Fear of cancer recurrence [Срок оценки: The primary outcome will be evaluated at approx. 12 months follow-up]
• Fear of cancer recurrence [Срок оценки: The primary outcome will be evaluated at approx. 24 months follow-up]

Вторичные конечные точки (12)

• Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Anxiety score will be evaluated at approx.12 months follow-up]
• Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7) [Срок оценки: Anxiety score will be evaluated at approx. 24 months follow-up]
• Evaluation of change from baseline in distress score by the validated distress thermometer [Срок оценки: Distress score will be evaluated at approx. 6-8 months after randomization.]
• Evaluation of change from baseline in distress score by the validated distress thermometer [Срок оценки: Distress score will be evaluated at approx.12 months follow-up]
• Evaluation of change from baseline in distress score by the validated distress thermometer [Срок оценки: Distress score will be evaluated at approx. 24 months follow-up]
• Evaluation of change from baseline in activation score by the validated patient activation measure [Срок оценки: Activation measure will be evaluated at approx. 6-8 months after randomization.]
• Evaluation of change from baseline in activation score by the validated patient activation measure [Срок оценки: Activation measure will be evaluated at approx.12 months follow-up]
• Evaluation of change from baseline in activation score by the validated patient activation measure [Срок оценки: Activation measure will be evaluated at approx. 24 months follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Дания · 1 центр

• Herlev and Gentofte Hospital — Copenhagen

Публикации

• 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

Идентификаторы

NCT: NCT05253872 · Melacare v1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗