Clinical trial NCT05253872: The MELAcare Study: A New Method for Surveillance of Melanoma Patients
Official title: The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cutaneous Melanoma
Keywords: cutaneous melanoma
follow-up
nurse-led follow-up
skin self-examination
survivorship
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2022-02-24
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Fear of cancer recurrence
timeFrame: The primary outcome will be evaluated at approx. 6-8 months after randomization.
measure: Fear of cancer recurrence
timeFrame: The primary outcome will be evaluated at approx. 12 months follow-up
measure: Fear of cancer recurrence
timeFrame: The primary outcome will be evaluated at approx. 24 months follow-up
Secondary outcomes:
measure: Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)
timeFrame: Depression score will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)
timeFrame: Depression score will be evaluated at approx. 12 months follow-up
measure: Evaluation of change from in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)
timeFrame: Depression score will be evaluated at 24 months follow-up
measure: Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)
timeFrame: Anxiety score will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)
timeFrame: Anxiety score will be evaluated at approx.12 months follow-up
measure: Evaluation of change from baseline in anxiety score by the validated General Anxiety Disorder-7 questionnaire (GAD-7)
timeFrame: Anxiety score will be evaluated at approx. 24 months follow-up
measure: Evaluation of change from baseline in distress score by the validated distress thermometer
timeFrame: Distress score will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of change from baseline in distress score by the validated distress thermometer
timeFrame: Distress score will be evaluated at approx.12 months follow-up
measure: Evaluation of change from baseline in distress score by the validated distress thermometer
timeFrame: Distress score will be evaluated at approx. 24 months follow-up
measure: Evaluation of change from baseline in activation score by the validated patient activation measure
timeFrame: Activation measure will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of change from baseline in activation score by the validated patient activation measure
timeFrame: Activation measure will be evaluated at approx.12 months follow-up
measure: Evaluation of change from baseline in activation score by the validated patient activation measure
timeFrame: Activation measure will be evaluated at approx. 24 months follow-up
measure: Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
timeFrame: Health status will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
timeFrame: Health status will be evaluated at approx.12 months follow-up
measure: Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
timeFrame: Health status will be evaluated at approx. 24 months follow-up
measure: Evaluation of change from baseline in work ability by the validated work ability index
timeFrame: Work ability will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of change from baseline in work ability by the validated work ability index
timeFrame: Work ability will be evaluated at approx.12 months follow-up
measure: Evaluation of change from baseline in work ability by the validated work ability index
timeFrame: Work ability will be evaluated at approx. 24 months follow-up
measure: Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
timeFrame: Time and costs spend will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
timeFrame: Time and costs spend will be evaluated at approx.12 months follow-up
measure: Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
timeFrame: Time and costs spend will be evaluated at approx. 24 months follow-up
measure: Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
timeFrame: the number of extra clinical consultations with a doctor will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
timeFrame: the number of extra clinical consultations with a doctor will be evaluated at approx. 12 months follow-up
measure: Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
timeFrame: the number of extra clinical consultations with a doctor will be evaluated at approx. 24 months follow-up
measure: Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
timeFrame: the number of extra clinical consultations with a doctor will be evaluated at approx. 60 months follow-up
measure: Evaluation of the number and characteristics of new primary melanomas and/or recurrences
timeFrame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of the number and characteristics of new primary melanomas and/or recurrences
timeFrame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx.12 months follow-up
measure: Evaluation of the number and characteristics of new primary melanomas and/or recurrences
timeFrame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 24 months follow-up
measure: Evaluation of the number and characteristics of new primary melanomas and/or recurrences
timeFrame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 60 months follow-up
measure: Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
timeFrame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
timeFrame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 12 months follow-up
measure: Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
timeFrame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 24 months follow-up
measure: Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
timeFrame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 60 months follow-up
measure: Evaluation of health care costs of the new follow-up program compared to the current
timeFrame: Health care costs evaluation will be evaluated at approx. 60 months follow-up
measure: Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
timeFrame: the number of extra scans will be evaluated at approx. 6-8 months after randomization.
measure: Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
timeFrame: the number of extra scans will be evaluated at approx. 12 months follow-up
measure: Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
timeFrame: the number of extra scans will be evaluated at approx. 24 months follow-up
measure: Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
timeFrame: the number of extra scans will be evaluated at approx. 60 months follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
affiliation: Herlev and Gentofte Hospital
name: Lisbet R Hölmich, Professor
role: STUDY_CHAIR
References: