Cutaneous MelanomaNCT05253872
The MELAcare Study: A New Method for Surveillance of Melanoma Patients
A study testing The MelaCare intervention in people with Cutaneous Melanoma, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- The MelaCare intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Mar 2022to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte Hospital
Copenhagen, 2730
Sara M Hansen, MD, +4538681296, sara.moelgaard.hansen@regionh.dk
Lisbet R Hölmich, Professor, +4538681243, lisbet.rosenkrantz.hoelmich@regionh.dk
About this study
Official title: The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
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
- Being tested
- The MelaCare intervention
- Keywords
- cutaneous melanoma, follow-up, nurse-led follow-up, skin self-examination, survivorship
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MelaCare interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity
Measured: 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)
The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity
Measured: 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)
The PhQ-9 has a scale from 0-27, and a higher score is associated with increase in depression severity
Measured: 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)
The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.
Measured: 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)
The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.
Measured: 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)
The GAD-7 has a scale from 0-21, and a higher score is associated with increase in anxiety severity.
Measured: Anxiety score will be evaluated at approx. 24 months follow-up
Evaluation of change from baseline in distress score by the validated distress thermometer
The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity
Measured: 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
The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity
Measured: Distress score will be evaluated at approx.12 months follow-up
Evaluation of change from baseline in distress score by the validated distress thermometer
The distress thermometer has a scale from 0-10, and a higher score is associated with increase in distress severity
Measured: 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
The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level
Measured: 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
The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level
Measured: 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
The patient activation measure has a 100-point scale, and a higher score is associated with increase in activation level
Measured: Activation measure will be evaluated at approx. 24 months follow-up
Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status
Measured: Health status will be evaluated at approx. 6-8 months after randomization.
Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status
Measured: Health status will be evaluated at approx.12 months follow-up
Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
The EQ-5D-3L has a 3-level scale, and a higher level is associated with decrease in health status
Measured: Health status will be evaluated at approx. 24 months follow-up
Evaluation of change from baseline in work ability by the validated work ability index
The work ability index has a scale from 7-49, where higher scores indicates better work ability.
Measured: Work ability will be evaluated at approx. 6-8 months after randomization.
Evaluation of change from baseline in work ability by the validated work ability index
The work ability index has a scale from 7-49, where higher scores indicates better work ability.
Measured: Work ability will be evaluated at approx.12 months follow-up
Evaluation of change from baseline in work ability by the validated work ability index
The work ability index has a scale from 7-49, where higher scores indicates better work ability.
Measured: Work ability will be evaluated at approx. 24 months follow-up
Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits
Measured: Time and costs spend will be evaluated at approx. 6-8 months after randomization.
Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits
Measured: Time and costs spend will be evaluated at approx.12 months follow-up
Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
The patients will fill in a study specific questionnaire informing time and money spent for transportation to and from the follow-up visits
Measured: Time and costs spend will be evaluated at approx. 24 months follow-up
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
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.
Measured: the number of extra clinical consultations with a doctor will be evaluated at approx. 6-8 months after randomization.
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
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.
Measured: the number of extra clinical consultations with a doctor will be evaluated at approx. 12 months follow-up
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
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.
Measured: the number of extra clinical consultations with a doctor will be evaluated at approx. 24 months follow-up
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
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.
Measured: the number of extra clinical consultations with a doctor will be evaluated at approx. 60 months follow-up
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
The investigator will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.
Measured: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 6-8 months after randomization.
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
The investigator will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.
Measured: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx.12 months follow-up
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.
Measured: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 24 months follow-up
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
The investigators will register any new melanomas and recurrences detected, and deaths. The data will be collected using medical records.
Measured: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 60 months follow-up
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
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.
Measured: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 6-8 months after randomization.
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
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.
Measured: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 12 months follow-up
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
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.
Measured: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 24 months follow-up
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
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.
Measured: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 60 months follow-up
Evaluation of health care costs of the new follow-up program compared to the current
We will evaluate the health care cost of new follow-up program compared to the current. Data will be collected using national registries.
Measured: Health care costs evaluation will be evaluated at approx. 60 months follow-up
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.
Measured: the number of extra scans will be evaluated at approx. 6-8 months after randomization.
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.
Measured: the number of extra scans will be evaluated at approx. 12 months follow-up
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.
Measured: the number of extra scans will be evaluated at approx. 24 months follow-up
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
The investigators will evaluate number of extra scans. The data will be collected using electronic patient journal.
Measured: the number of extra scans will be evaluated at approx. 60 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start9 Mar 2022
- Primary completionJun 2024 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Sara Molgaard Hansen, Herlev and Gentofte Hospital
- Investigators
- Lisbet R Hölmich, Professor, Study chair, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253872
- Sponsor's protocol ID
- Melacare v1.0
- Status last verified
- Jun 2023
- First submitted
- 24 Jan 2022
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plan to share IPD with other researchers.
Publications
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.
PubMed 40504479
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MELAcare Study: a Randomized Controlled Trial of a New Method for Surveillance of Melanoma Patients
- ClinicalTrials.gov ID
- NCT05253872
- Acronym / sponsor ID
- Melacare v1.0
- Conditions
- Cutaneous Melanoma
- Keywords
- cutaneous melanoma, follow-up, nurse-led follow-up, skin self-examination, survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: The MelaCare interventionPatients 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The MelaCare interventionThe 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. | Other | Intervention group |
Primary outcome
Fear of cancer recurrence
Time frame: The primary outcome will be evaluated at approx. 6-8 months after randomization.
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.
Fear of cancer recurrence
Time frame: The primary outcome will be evaluated at approx. 12 months follow-up
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.
Fear of cancer recurrence
Time frame: The primary outcome will be evaluated at approx. 24 months follow-up
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.
38 secondary outcomes
Evaluation of change from baseline in depression score by the validated Patient Health Questionnaire-9 (PhQ-9)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Anxiety score will be evaluated at approx. 24 months follow-up
Evaluation of change from baseline in distress score by the validated distress thermometer
Time frame: 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
Time frame: Distress score will be evaluated at approx.12 months follow-up
Evaluation of change from baseline in distress score by the validated distress thermometer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Activation measure will be evaluated at approx. 24 months follow-up
Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
Time frame: Health status will be evaluated at approx. 6-8 months after randomization.
Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
Time frame: Health status will be evaluated at approx.12 months follow-up
Evaluation of change from baseline in health status by the validated Euroqol 5 dimensions, 3 levels questionnaire (EQ-5D-3L)
Time frame: Health status will be evaluated at approx. 24 months follow-up
Evaluation of change from baseline in work ability by the validated work ability index
Time frame: Work ability will be evaluated at approx. 6-8 months after randomization.
Evaluation of change from baseline in work ability by the validated work ability index
Time frame: Work ability will be evaluated at approx.12 months follow-up
Evaluation of change from baseline in work ability by the validated work ability index
Time frame: Work ability will be evaluated at approx. 24 months follow-up
Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
Time frame: Time and costs spend will be evaluated at approx. 6-8 months after randomization.
Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
Time frame: Time and costs spend will be evaluated at approx.12 months follow-up
Evaluation of the time and costs spend by the patients getting to and from the follow-up visits
Time frame: Time and costs spend will be evaluated at approx. 24 months follow-up
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 6-8 months after randomization.
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 12 months follow-up
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 24 months follow-up
Evaluation of the number of extra clinical consultations with a doctor at the outpatient clinic
Time frame: the number of extra clinical consultations with a doctor will be evaluated at approx. 60 months follow-up
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 6-8 months after randomization.
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx.12 months follow-up
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 24 months follow-up
Evaluation of the number and characteristics of new primary melanomas and/or recurrences
Time frame: Number and characteristics of new primary melanoma and/or recurrences will be evaluated at approx. 60 months follow-up
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 6-8 months after randomization.
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 12 months follow-up
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 24 months follow-up
Evaluation of time to diagnosis of a new primary melanoma and/or recurrence
Time frame: Time to diagnosis of a new primary melanoma and/or recurrence will be evaluated at approx. 60 months follow-up
Evaluation of health care costs of the new follow-up program compared to the current
Time frame: Health care costs evaluation will be evaluated at approx. 60 months follow-up
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
Time frame: the number of extra scans will be evaluated at approx. 6-8 months after randomization.
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
Time frame: the number of extra scans will be evaluated at approx. 12 months follow-up
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
Time frame: the number of extra scans will be evaluated at approx. 24 months follow-up
Evaluation of the number of extra scans: Magnetic Resonance Imaging (MRI), computed tomography (CT), ultrasound, or positron emission tomography/computed tomography (PET/CT)
Time frame: the number of extra scans will be evaluated at approx. 60 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 40504479Hansen 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.
- Individual participant dataSharing planned: No. There are no plan to share IPD with other researchers.
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Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisbet R Hölmich, Professor study chair
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MelaCare intervention in people with Cutaneous Melanoma, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M Hansen, MD (+4538681296, sara.moelgaard.hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of cancer recurrence (time frame: The primary outcome will be evaluated at approx. 6-8 months after randomization.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253872, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.